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Exercise and Manual Physiotherapy Arthritis Research Trial (EMPART) for Osteoarthritis of the Hip: A Multicenter Randomized Controlled Trial

Published:October 19, 2012DOI:https://doi.org/10.1016/j.apmr.2012.09.030

      Abstract

      Objectives

      To determine the effectiveness of exercise therapy (ET) compared with ET with adjunctive manual therapy (MT) for people with hip osteoarthritis (OA); and to identify if immediate commencement of treatment (ET or ET+MT) was more beneficial than a 9-week waiting period for either intervention.

      Design

      Assessor-blind randomized controlled trial with a 9-week and 18-week follow-up.

      Setting

      Four academic teaching hospitals in Dublin, Ireland.

      Participants

      Patients (N=131) with hip OA recruited from general practitioners, rheumatologists, orthopedic surgeons, and other hospital consultants were randomized to 1 of 3 groups: ET (n=45), ET+MT (n=43), and waitlist controls (n=43).

      Interventions

      Participants in both the ET and ET+MT groups received up to 8 treatments over 8 weeks. Control group participants were rerandomized into either ET or ET+MT groups after 9 week follow-up. Their data were pooled with original treatment group data: ET (n=66) and ET+MT (n=65).

      Main Outcome Measures

      The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function (PF) subscale. Secondary outcomes included physical performance, pain severity, hip range of motion (ROM), anxiety/depression, quality of life, medication usage, patient-perceived change, and patient satisfaction.

      Results

      There was no significant difference in WOMAC PF between the ET (n=66) and ET+MT (n=65) groups at 9 weeks (mean difference, .09; 95% confidence interval [CI] −2.93 to 3.11) or 18 weeks (mean difference, .42; 95% CI, −4.41 to 5.25), or between other outcomes, except patient satisfaction with outcomes, which was higher in the ET+MT group (P=.02). Improvements in WOMAC, hip ROM, and patient-perceived change occurred in both treatment groups compared with the control group.

      Conclusions

      Self-reported function, hip ROM, and patient-perceived improvement occurred after an 8-week program of ET for patients with OA of the hip. MT as an adjunct to exercise provided no further benefit, except for higher patient satisfaction with outcome.

      Keywords

      List of abbreviations:

      EMPART (Exercise and Manual Physiotherapy Arthritis Research Trial), ET (exercise therapy), HADS (Hospital Anxiety and Depression Scale), HEP (home exercise program), MCID (minimal clinically important difference), MT (manual therapy), OA (osteoarthritis), PF (physical function), PGA (Patient Global Assessment), RCT (randomized controlled trial), ROM (range of motion), SF-36 (Medical Outcomes Study 36-Item Short-Form Health Survey), WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
      Hip osteoarthritis (OA) is a painful and disabling condition that can impact on everyday activities and quality of life.
      • Dominick K.L.
      • Ahern F.M.
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      Health-related quality of life and health service use among older adults with osteoarthritis.
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      • Stam H.J.
      • et al.
      Actual everyday physical activity in patients with end-stage hip or knee osteoarthritis compared with healthy controls.
      A lifetime prevalence of 25.3% has been reported,
      • Murphy L.B.
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      • Schwartz T.A.
      • et al.
      One in four people may develop symptomatic hip osteoarthritis in his or her lifetime.
      and this is associated with increasing age. Conservative treatments include exercise therapy (ET) and manual therapy (MT).
      • French H.P.
      Physiotherapy management of osteoarthritis of the hip: a survey of current practice in acute hospitals and private practice in the Republic of Ireland.
      • Cowan S.M.
      • Blackburn M.S.
      • McMahon K.
      • Bennell K.L.
      Current Australian physiotherapy management of hip osteoarthritis.
      Although ET has demonstrated beneficial effects for hip OA in recommended core outcomes
      • Bellamy N.
      • Kirwan J.
      • Boers M.
      • et al.
      Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III.
      of pain
      • Fransen M.
      • McConnell S.
      • Hernandez-Molina G.
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      Exercise for osteoarthritis of the hip.
      • Hernández-Molina G.
      • Reichenbach S.
      • Zhang B.
      • Lavalley M.
      • Felson D.T.
      Effect of therapeutic exercise for hip osteoarthritis pain: results of a meta-analysis.
      and patient-perceived improvement (Patient Global Assessment [PGA])
      • van Baar M.E.
      • Dekker J.
      • Oostendorp R.A.
      • et al.
      The effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized clinical trial.
      • Veenhof C.
      • Koke A.J.
      • Dekker J.
      • et al.
      Effectiveness of behavioral graded activity in patients with osteoarthritis of the hip and/or knee: a randomized clinical trial.
      in the short and medium term, results for changes in physical function (PF) are conflicting. A number of randomized controlled trials (RCTs), some of which have included participants with hip or knee OA, have found functional benefits with exercise,
      • van Baar M.E.
      • Dekker J.
      • Oostendorp R.A.
      • et al.
      The effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized clinical trial.
      • Foley A.
      • Halbert J.
      • Hewitt T.
      • Crotty M.
      Does hydrotherapy improve strength and physical function in patients with osteoarthritis–a randomised controlled trial comparing a gym based and a hydrotherapy based strengthening programme.
      • Tak E.
      • Staats P.
      • Van Hespen A.
      • Hopman-Rock M.
      The effects of an exercise program for older adults with osteoarthritis of the hip.
      but a meta-analysis, based on data from participants with hip OA only, found no effect on PF.
      • Fransen M.
      • McConnell S.
      • Hernandez-Molina G.
      • Reichenbach S.
      Exercise for osteoarthritis of the hip.
      The small number of participants (n = 204) and interstudy heterogeneity may have influenced this finding. Long-term (>6mo) follow-ups of exercise-based RCTs have found that posttreatment improvements in pain and function were not maintained,
      • van Baar M.E.
      • Dekker J.
      • Oostendorp R.A.
      • Bijl D.
      • Voorn T.B.
      • Bjlsma J.W.
      Effectiveness of exercise in patients with osteoarthritis of hip or knee: nine months' follow up.
      • Hughes S.L.
      • Seymour R.B.
      • Campbell R.T.
      • et al.
      Long-term impact of Fit and Strong! on older adults with osteoarthritis.
      • Hopman-Rock M.
      • Westhoff M.H.
      The effects of a health educational and exercise program for older adults with osteoarthritis for the hip or knee.
      but it is unclear at what point benefits dissipate after treatment and long-term follow-up.
      There is, therefore, a need to identify the medium-term effects of physiotherapy for hip OA. MT, which is the use of hands-on techniques delivered to the joint or soft tissues to modulate pain and improve joint mobility,
      • Deyle G.D.
      • Henderson N.E.
      • Matekel R.L.
      • Ryder M.G.
      • Garber M.B.
      • Allison S.C.
      Effectiveness of manual physical therapy and exercise in osteoarthritis of the knee. A randomized, controlled trial.
      is used for the treatment of pain and disability associated with hip OA.
      • French H.P.
      Physiotherapy management of osteoarthritis of the hip: a survey of current practice in acute hospitals and private practice in the Republic of Ireland.
      • Cowan S.M.
      • Blackburn M.S.
      • McMahon K.
      • Bennell K.L.
      Current Australian physiotherapy management of hip osteoarthritis.
      It can be administered as high-velocity manipulative techniques or lower-grade joint mobilizations.
      • Mulligan B.
      Manual Therapy, NAGs, SNAGs, MWMs etc.
      • Hengeveld E.
      • Banks K.
      Maitland's peripheral manipulation.
      Although clinical guidelines recommend MT as an adjunctive therapy in the management of hip OA,

      National Institute of Clinical Excellence. Osteoarthritis: the care and management of osteoarthritis in adults. 2008. Available at: http://www.nice.org.uk/nicemedia/pdf/CG59NICEguideline.pdf. Accessed November 20, 2009.

      the scientific evidence supporting this recommendation is based on 1 RCT, which compared MT head to head with ET, rather than as an adjunct, and found that MT was superior in pain, function, and PGA outcomes.
      • Hoeksma H.L.
      • Dekker J.
      • Ronday H.K.
      • et al.
      Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.
      A more recent RCT found no difference in outcomes between targeted hip MT with exercise and full kinetic chain MT with exercise delivered by chiropractors.
      • Brantingham J.W.
      • Parkin-Smith G.
      • Cassa T.K.
      • et al.
      Full kinetic chain manual and manipulative therapy plus exercise compared with targeted manual and manipulative therapy plus exercise for symptomatic osteoarthritis of the hip: a randomized controlled trial.
      Neither of these trials included a control group. The aim of this RCT was to determine if the addition of MT to an 8-week program of ET for hip OA improved function and other clinical outcomes more than ET alone at 9 and 18 weeks. A secondary aim was to ascertain if immediate commencement of treatment (ET or ET+MT) resulted in better outcomes compared with a 9-week waiting period for either intervention.

      Methods

      Design

      The Exercise and Manual Physiotherapy Arthritis Research Trial (EMPART) multicenter RCT was conducted in 4 academic teaching hospitals in an urban area in Ireland.
      The study was approved by each of the hospital's research committees. An initial 3 group parallel arm trial (allocation ratio 1:1:1) was used, with a modified cross-over design, whereby control group participants were crossed over to 1 of 2 intervention arms after a 9-week period, thereby ensuring sufficient power to test the primary trial hypothesis. Details of EMPART protocol are published elsewhere.
      • French H.P.
      • Cusack T.
      • Brennan A.
      • et al.
      Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial.

      Participants

      The principal investigator (H.P.F.) screened all patients for trial eligibility and enrolled participants after receipt of written informed consent.
      Participants referred from rheumatologists, orthopedic surgeons, other hospital consultants, and general practitioners were recruited from physiotherapy waitlists. Waiting times for physiotherapy varied from 6 weeks to 6 months across the 4 trial sites. Participants were included if they had OA of the hip according to the American College of Rheumatology clinical and radiographic criteria
      • Altman R.
      • Alarcon G.
      • Appelrouth D.
      • et al.
      The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip.
      and were aged 40 to 80 years. Exclusion criteria included previous hip arthroplasty, congenital or adolescent hip disease, clinical signs of lumbar spine disease, physiotherapy in the previous 6 months for hip symptoms, pregnancy, hip fracture, contraindications to ET,
      • American Geriatrics Society Panel on Exercise and Osteoarthritis
      Exercise prescription for older adults with osteoarthritis pain: consensus practice recommendations.
      inflammatory arthritis, on the waitlist for hip joint replacement within the next 7 months, intra-articular hip corticosteroid injection in the previous 30 days, or insufficient understanding of the English language to complete questionnaires.

      Randomization

      Two computer generated randomization lists were compiled by an independent statistician. The first list randomized participants into 1 of 3 arms: ET, ET+MT, or a waitlist control group. The second list rerandomized control group participants into 1 of 2 intervention groups (ET or ET+MT) after the 9-week follow-up assessment. Both lists were maintained by a member of the research team (T.C.), who was located offsite from the 4 trial centers and was not involved in participant assessment or treatment. Simple randomization was conducted after email notification of patient recruitment by the principal investigator. Group allocation was communicated via email by the independent randomizer to the treating therapists in each treatment site.

      Blinding

      A single assessor (H.P.F.), blinded to group allocation and measurement data from previous assessment points, carried out all outcome assessments. Patients were requested not to divulge information regarding allocated treatment. Disclosure of group allocation was recorded prospectively by the blinded assessor.

      Interventions

      The ET and ET+MT interventions were administered by senior grade or clinical specialist physiotherapists (n=23) in the 4 participating hospitals. Training in the 2 treatment protocols was provided by the principal investigator (H.P.F.) along with a comprehensive written manual in order to ensure a standardized approach to treatment across the trial centers.
      All therapists at all sites provided either ET or ET+MT interventions.
      All participants were treated according to the protocol detailed in appendix 1.

      Exercise therapy

      Participants attended 6 to 8 individual 30-minute physiotherapy sessions over 8 weeks, which included flexibility and strengthening exercises delivered using a semi-structured protocol. The protocol provided guidance on exercise prescription and progression, but could be tailored to individual patient physical assessment findings.
      Strengthening focused on low-load exercise, commencing in nonweight-bearing positions, and progressing to functional positions. The key target muscles were the gluteal muscles, which are commonly atrophied in hip OA.
      • Grimaldi A.
      • Richardson C.
      • Durbridge G.
      • Donnelly W.
      • Darnell R.
      • Hides J.
      The association between degenerative hip joint pathology and size of the gluteus maximus and tensor fascia lata muscles.
      • Grimaldi A.
      • Richardson C.
      • Stanton W.
      • Durbridge G.
      • Donnelly W.
      • Hides J.
      The association between degenerative hip joint pathology and size of the gluteus medius, gluteus minimus and piriformis muscles.
      A daily home exercise program (HEP) supplemented the clinic-based treatment. Adherence to the HEP was measured using a self-report exercise diary.
      Participants were also encouraged to undertake aerobic exercise, such as walking, cycling, or swimming for at least 30 minutes, 5 days a week,
      American College of Sports Medicine
      ACSM guidelines for exercise prescription in OA.
      and were given written and verbal information on the principles of aerobic conditioning, such as pacing, gradually progressing intensity and time of exercise, and incorporating exercise into daily life.

      Exercise therapy and manual therapy

      Participants attended 6 to 8 individual 45-minute physiotherapy sessions over an 8-week period, which included 30 minutes of ET, as previously described, and up to 15 minutes of MT in line with current clinical practice at participating sites. A choice of nonmanipulative MT techniques based on pain/stiffness relations
      • Mulligan B.
      Manual Therapy, NAGs, SNAGs, MWMs etc.
      • Hengeveld E.
      • Banks K.
      Maitland's peripheral manipulation.
      and movement restrictions of the affected hip was available, with no more than 5 MT techniques allowed during an individual session.

      Control group

      Participants in the control group remained on the physiotherapy waitlist and completed a follow-up assessment with the blinded outcome assessor at 9 weeks, after which they were rerandomized into either the ET or ET+MT group.
      All 3 groups received standardized written information on hip OA.
      • Zhang W.
      • Moskowitz R.W.
      • Nuki G.
      • Abramson S.
      • Altman R.D.
      • Arden N.
      OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines.
      All nonconsenting and excluded participants were treated as usual by the physiotherapy department in each trial center. Participants were asked to avoid all other interventions for the duration of the RCT, apart from routine doctor care and analgesics. Participants with bilateral hip OA received clinic-based treatment for the more symptomatic hip only, but were provided with an HEP for both hips.

      Outcomes

      Outcomes were chosen according to internationally recommended core outcomes for hip or knee OA.
      • Bellamy N.
      • Kirwan J.
      • Boers M.
      • et al.
      Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III.
      The primary outcome was self-reported PF, as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert version) PF subscale for hip OA.
      • Bellamy N.
      • Buchanan W.W.
      • Goldsmith C.H.
      • Campbell J.
      • Stitt L.W.
      Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee.
      This has moderate to high validity and reliability,
      • McConnell S.
      • Kolopack P.
      • Davis A.M.
      The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties.
      with lower scores indicating better functional status. Secondary outcomes included observed PF measured with the 5 times sit-to-stand test
      • Simmonds M.J.
      Measuring and managing pain and performance.
      and the 50-foot walk test.
      • Grace E.M.
      • Gerecz E.M.
      • Kassam Y.B.
      • Buchanan H.M.
      • Buchanan W.W.
      • Tugwell P.S.
      50-foot walking time: a critical assessment of an outcome measure in clinical therapeutic trials of antirheumatic drugs.
      Active hip range of motion (ROM) was measured using goniometry for flexion, abduction, medial rotation, and the Thomas test.
      • Norkin C.
      • White D.
      Measurement of joint motion: a guide to goniometry.
      These scores were combined to give an aggregate ROM score. Flexion/abduction/external rotation (FABER) was measured separately using a measuring tape.
      • Theiler R.
      • Stucki G.
      • Schutz R.
      • et al.
      Parametric and non-parametric measures in the assessment of knee and hip osteoarthritis: interobserver reliability and correlation with radiology.
      ROM and physical performance procedures demonstrated excellent test-retest reliability (intraclass correlation coefficient >.90) in a subgroup of people with and without hip OA.
      • French H.P.
      A multi-centre randomised controlled trial evaluating exercise and manual therapy for osteoarthritis of the hip. PhD thesis.
      Pain severity (with activity and at night) was measured using a Numerical Rating Scale, and pain medication usage was quantified using the Medication Quantification Scale.
      • Gallizzi M.
      • Gagnon C.
      • Harden R.N.
      • Stanos S.
      • Khan A.
      Medication Quantification Scale Version III: internal validation of detriment weights using a chronic pain population.
      Other outcomes included general health status (Medical Outcomes Study 36-Item Short-Form Health Survey [SF-36]) and psychological well-being (Hospital Anxiety and Depression Scale [HADS]).
      • Zigmond A.S.
      • Snaith R.P.
      The hospital anxiety and depression scale.
      PGA of change was assessed using a 7-point scale (very much worse to very much better), and the Physiotherapy Outpatient Survey assessed patient satisfaction.
      • Hills R.
      • Kitchen S.
      Satisfaction with outpatient physiotherapy: a survey comparing the views of patients with acute and chronic musculoskeletal conditions.

      Sample size

      The WOMAC PF subscale was used to estimate the sample size required. Using a previously ascertained minimal clinically important difference (MCID) ± SD of 5.4 ± 11 on the WOMAC Likert scale,
      • Tubach F.
      • Ravaud P.
      • Baron G.
      • et al.
      Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement.
      with a significance level of .05 (2-tailed) and a power of 80%, 67 patients were required per group, based on the final group allocation to ET or ET+MT. This was increased to 74 patients per group to allow for 10% attrition at the 18-week follow-up, thus requiring a total sample of 148 participants.

      Statistical analysis

      Analyses were conducted on an intention-to-treat basis. Missing data were replaced using multivariate multiple imputation (Stata version 12a). Twenty imputed datasets were generated using a model whereby data were considered missing at random. Imputations were based on baseline demographic variables (age, sex, occupation, and body mass index) and predictor variables, such as symptom duration, baseline pain, PF, psychological health, and general health status. An overall significance level of P=.05 was set. To address the primary study aim, comparisons were made between the ET and ET+MT groups at baseline, 9 weeks, and 18 weeks, and participants in the control group were analyzed according to the intervention received after the 9-week follow-up. Comparisons were made between the control group and the 2 treatment groups combined (ET and ET+MT) at baseline and 9 weeks in order to address the secondary study aim. Linear regression modeling was used to examine between-group differences, with adjustment for baseline levels of the outcome. For the 2 group analysis, baseline WOMAC PF and aggregate ROM were included as covariates because of baseline differences. Pain medication usage, aggregate ROM, sit-to-stand, and WOMAC PF subscale were added as covariates for the 3 group analysis because of baseline differences in these variables.
      Quantile regression was used for nonnormally distributed outcomes. PGA ratings were dichotomized as improved (very much better, much better, somewhat better), no change, and worse (very much worse, much worse, and somewhat worse), and chi-square analysis was used to test for differences between the groups.

      Results

      Participants

      One hundred and thirty-one patients were recruited across the 4 sites between May 2008 and February 2010. In the initial 3 group allocation, 43 patients were randomized each to the ET+MT and control groups, and 45 were randomized to the ET group. Figure 1 shows participant flow through the trial. Eight patients (6.1%) withdrew from the trial at 9 weeks: 4 declined continuation, 1 had hip surgery, 1 developed cardiac symptoms, 1 could not be contacted by the researcher, and 1 withdrew for family reasons. By 18 weeks, a further 11 (8.4%) withdrew: 5 underwent hip surgery, 1 could not be contacted, and 5 declined follow-up for personal reasons. This resulted in an overall dropout rate of 14.5%. Table 1 shows the baseline characteristics as determined by the 2 group (ET and ET+MT) allocation. Baseline characteristics for the 3 groups are shown in table 2.
      Figure thumbnail gr1
      Fig 1Flow of participants through the trial. *Missing data were imputed using multiple imputation methods.
      Table 1Baseline characteristics for the ET and ET+MT groups
      VariableET (n=66)ET+MT (n=65)
      Sex
       Female44 (66.7)40 (61.5)
      Body mass index (kg/m2)
       Healthy15 (23.7)18 (27.7)
       Overweight/obese51 (76.3)47 (72.3)
      Referral source
       Orthopedics20 (30.3)17 (26.2)
       Rheumatology26 (39.4)37 (56.9)
       GP15 (22.7)7 (10.8)
       Other consultants5 (7.5)4 (6.1)
      Occupation
       Retired24 (36.4)16 (24.6)
       Homemaker22 (33.3)20 (30.8)
       Paid employment16 (24.2)23 (35.3)
       Other4 (6.0)6 (9.25)
      Pain medications
       No medication21 (31.8)17 (26.2)
       Analgesics37 (56.1)39 (60.0)
       NSAIDs24 (36.4)21 (32.3)
      Hip affected
       One55 (73.3)45 (69.2)
       Both11 (16.7)20 (30.8)
      Age (y)62.44±9.0961.43±10.76
      Symptom duration (mo)33.21±37.7736.43±51.75
      Comorbidities (no.)1.97±1.362.38±1.45
      WOMAC PF33.48±14.6735.57±13.57
      HADS anxiety6.10±3.866.17±4.27
      HADS depression4.92±3.404.50±3.01
      SF-36 PCS36.17±9.4234.31±8.95
      SF-36 MCS50.99±12.2450.65±11.02
      Aggregate ROM (deg)119.36±27.62125.18±24.36
      FABER ROM (cm)30.99±7.1532.09±6.57
      Sit-to-stand (s)13.60±6.1814.72±9.45
      50-foot walk test (s)14.14±7.2014.44±5.81
      Pain with activity5.64±2.805.88±2.28
      Pain at night5.12±3.274.59±3.34
      Pain medication usage (MQS)6.03±5.645.84±4.94
      NOTE. Values are mean ± SD or n (% within group).
      Abbreviations: FABER, flexion, abduction, external rotation; GP, general practitioner; MCS, Mental Component Summary; MQS, Medication Quantification Scale; NSAIDs, nonsteroidal anti-inflammatory drugs; PCS, Physical Component Summary.
      Table 2Baseline characteristics for the ET, ET+MT, and control groups
      VariableET

      (n=45)
      ET+MT

      (n=43)
      Control

      (n=43)
      No. (% within each group)No. (% within each group)No. (% within each group)
      Sex
       Male11 (24.40)16 (37.2)20 (46.50)
       Female34 (74.50)27 (62.8)23 (53.50)
      Body mass index (kg/m2)
       Healthy13 (28.90)9 (20.9)7 (16.30)
       Overweight/obese32 (71.10)34 (79.1)36 (84.70)
      Pain medications
      Proportions do not add up to 100%, as more than type of pain medication may have been taken.
       No medications14 (36.80)10 (26.3)14 (36.80)
       Analgesics24 (53.30)27 (62.8)25 (58.10)
       NSAIDs14 (31.10)16 (37.2)15 (34.90)
      Referral source
       Orthopedics14 (31.10)11 (25.6)12 (27.90)
       Rheumatology17 (37.80)27 (62.8)21 (48.80)
       GP12 (26.70)4 (9.3)5 (14.70)
       Other consultants2 (4.40)3 (6.6)3 (2.70)
      Occupation
       Retired16 (35.60)16 (35.6)15 (34.90)
       Homemaker11 (22.40)18 (41.9)13 (30.20)
       Paid employment16 (35.60)13 (30.2)11 (25.60)
       Other2 (4.50)4 (9.3)4 (9.30)
      Hip affected
       Left13 (28.95)8 (18.6)9 (23.35)
       Right23 (51.10)20 (46.5)26 (60.55)
       Both9 (20.00)15 (34.9)7 (16.35)
      Use of walking aids
       None38 (84.40)36 (83.7)39 (90.60)
       Stick for long walk4 (8.90)2 (4.7)2 (4.70)
      Stick most of time3 (6.70)5 (11.6)2 (4.70)
      Mean ± SDMean ± SDMean ± SD
      Age (y)61.76±9.7264.83±9.8260.81±9.73
      Symptom duration (mo)33.00±41.5637.16±59.833.30±30.04
      Comorbidities2.00±1.262.60±1.481.86±1.36
      WOMAC PF32.29±12.2135.56±13.3932.91±14.88
      HADS anxiety5.80±3.356.42±4.685.07±3.29
      HADS depression4.58±2.954.28±3.544.37±2.85
      SF-36 PCS36.51±9.8735.27±8.7536.60±9.11
      SF-36 MCS52.78±10.7550.56±11.0252.82±11.48
      Aggregate ROM (deg)122.65±21.62121.56±26.24124.87±24.47
      FABER ROM (cm)31.36±5.6833.42±5.8429.33±7.41
      Sit-to-stand (s)13.18±4.7115.88±11.2014.15±6.23
      50-foot walk test (s)13.72±4.3715.18±6.4413.52±5.69
      Median (IQR)Median (IQR)Median (IQR)
      Pain with activity6 (4)6 (3)5 (4)
      Pain at night5 (5)5 (6)4 (7)
      Pain at rest3 (5)4 (5)3 (5)
      Abbreviations: FABER, flexion, abduction, external rotation; GP, general practitioner; IQR, interquartile range; MCS, Mental Component Summary; NSAIDs, nonsteroidal anti-inflammatory drugs; PCS, Physical Component Summary.
      Proportions do not add up to 100%, as more than type of pain medication may have been taken.

      Success of blinding

      Group assignment was disclosed to the outcome assessor by 5 participants, who were all in the control group. No treatment disclosure occurred in the 2 intervention groups.

      Outcomes

      Two group analysis (ET and ET+MT)

      At both the 9- and 18-week time points, there was no significant difference between the ET and ET+MT groups for any outcomes (table 3), with the exception of patient satisfaction with outcome, which was higher for the ET+MT group (table 4).
      Table 3Primary and secondary outcomes for ET and ET+MT groups at baseline, 9 weeks, and 18 weeks
      OutcomeBaseline9wk18wkDifference Between Groups
      Adjusted for baseline outcome and the following covariates: baseline WOMAC and baseline aggregate ROM.
      ET+MT (n=65)ET (n=66)ET+MT (n=65)ET (n=66)ET+MT (n=65)ET (n=66)9wk18wk
      Mean ± SDMean ± SDMean ± SDMean ± SDMean ± SDMean ± SDMean (95% CI)Mean (95% CI)
      WOMAC PF (0–68)35.57±13.5733.48±14.6729.66±17.1629.50±17.9830.53±19.1630.30±19.330.09 (−2.93 to 3.11)0.42 (−4.41 to 5.25)
      HADS anxiety (0–21)6.17±4.276.10±3.866.00±5.576.48±4.906.06±5.766.36±4.990.60 (−0.86 to 2.07)0.343 (−1.01 to 1.86)
      HADS depression (0–21)4.50±3.014.92±3.404.80±4.394.89±3.824.34±3.995.16±4.100.19 (−1.33 to 0.95)0.58 (−0.58 to 1.75)
      SF-36 Physical Summary Score34.31±8.9536.17±9.4235.61±10.7237.50±11.3834.68±12.2736.45±12.360.77 (−2.20 to 3.74)0.98 (−2.61 to 4.57)
      SF-36 Mental Summary Score50.65±11.0250.99±12.2449.29±15.5849.33±13.4250.73±14.6847.78±14.41−0.28 (−4.09 to 3.53)−3.43 (−7.38 to 0.52)
      Aggregate ROM (deg)125.18±24.36119.36±27.62141.99±32.66132.94±36.93139.24±41.13131.83±39.79−5.40 (−14.29 to 3.49)−4.41 (−15.38 to 6.55)
      FABER ROM (cm)32.09±6.5730.99±7.1530.03±8.3529.23±7.9330.29±9.0729.79±8.541.0 (−1.88 to 2.06)0.54 (−1.75 to 2.83)
      Sit-to-stand (s)14.72±9.4513.60±6.1813.73±9.0713.17±7.3313.96±13.9312.80±9.24−0.02 (−2.03 to 2.09)−0.02 (−3.03 to 3.00)
      50-foot walk test (s)14.44±5.8114.14±7.2014.36±7.5014.70±10.5315.04±9.4915.10±11.210.50 (−1.59 to 2.59)0.36 (−2.10 to 2.82)
      Pain severity with activity (NRS)5.88±2.285.64±2.804.32±3.314.92±3.464.37±3.864.67±3.97−0.18 (−1.73 to 1.36)−0.22 (−2.14 to 1.71)
      Night pain severity (NRS)5.12±3.274.59±3.343.97±3.863.52±3.434.65±4.393.91±3.780.36 (−1.76 to 1.05)−0.67 (−2.27 to 1.71)
      Pain medication usage (MQS)5.84±4.946.03±5.645.17±5.075.64±5.913.97±5.195.49±6.60.64 (−1.39 to 2.67)1.85 (−0.82 to 4.52)
      Abbreviations: CI, confidence interval; FABER, flexion, abduction, external rotation; IQR, interquartile range; MQS, Medication Quantification Scale; NRS, Numerical Rating Scale; OR, odds ratio.
      Adjusted for baseline outcome and the following covariates: baseline WOMAC and baseline aggregate ROM.
      Table 4Patient satisfaction and global assessment of change outcomes for ET and ET+MT groups
      Physiotherapy Outpatient Survey at 18wkET+MT Median (IQR) (n=65)ET Median (IQR) (n=66)Median Difference Between Groups (95% CI)P (between group)
      Mann-Whitney U test.
      Expectations (0–5)3.40 (1.05)3.60 (1.00)−0.20 (−0.42 to 0.40)0.44
      Communication (0–5)4.5 (0.83)4.5 (0.83)0.00 (−0.34 to 0.35)0.27
      Therapist (0–5)4.67 (0.83)4.31 (0.67)0.36 (−0.50 to 0.01)0.12
      Organization (0–5)4.29 (0.93)4.14 (0.71)0.15 (−0.43 to 0.16)0.50
      Outcome (0–5)3.20 (1.20)2.80 (1.00)0.40 (0.60 to 0.00)0.02
      Satisfaction (0–5)4.17 (0.59)4.25 (0.67)−0.07 (−0.16 to 0.16)1.00
      Overall (0–5)4.01 (0.52)3.97 (0.56)−0.04 (0.32 to 0.06)0.17
      PGANo. (% improved)No. (% improved)OR (95% CI)P
      Chi-square analysis.
      (between group)
      9wk45 (69.7)40 (60.6)1.46 (0.72 to 2.98)0.73
      18wk33 (50.8)28 (42.4)1.39 (0.70 to 2.76)0.87
      Abbreviations: CI, confidence interval; IQR, interquartile range; OR, odds ratio.
      Chi-square analysis.
      Mann-Whitney U test.

      Three group analysis (control vs ET and ET+MT)

      At 9 weeks, analysis of data from the initial 3 group randomization (table 5) demonstrated significant improvements in the treatment groups compared with the control group in WOMAC PF, aggregate ROM, and PGA. There was no significant difference between the control and 2 treatment groups in the remaining outcomes.
      Table 5Outcomes for ET, ET+MT, and control groups at 9 weeks
      OutcomeET+MT (n=43)ET (n=45)Control (n=43)ET+MT and ET vs Control (95% CI)
      Adjusted for baseline outcome and the following covariates: baseline WOMAC PF, aggregate ROM, sit-to-stand, and MQS.
      P
      Mean ± SDMean ± SDMean ± SDMean Difference (95% CI)
      WOMAC PF (0–68)
       Baseline35.56±13.3932.29±12.2132.91±15.227.76 (2.80 to 12.72).002
       9wk29.31±17.0628.08±15.4836.09±16.41
      HADS anxiety (0–21)
       Baseline6.42±4.685.80±3.355.07±3.370.07 (−1.26 to 1.41).920
       9wk6.31±5.546.74±4.276.14±3.97
      HADS depression (0–21)
       Baseline4.28±3.544.58±2.954.37±2.92−0.67 (−1.85 to 0.51).260
       9wk4.83±4.635.02±3.395.58±3.45
      SF-36 Physical Component Summary (0–100)
       Baseline35.27±8.7536.51±9.8736.60±9.32−1.75 (−0.12 to 6.84).060
       9wk35.61±11.2237.03±11.2533.82±9.67
      SF-36 Mental Component Summary (0–100)
       Baseline50.56±11.0252.78±10.7552.82±11.750.02 (−3.72 to 3.69).990
       9wk49.92±15.4148.92±12.5048.52±13.75
      Aggregate ROM (deg)
       Baseline121.56±26.24118.88±30.16124.87±25.0315.85 (6.69 to 25.00).001
       9wk139.98±31.71136.09±28.86123.72±29.67
      FABER
       Baseline33.42±5.8431.19±6.3329.24±7.91−1.86 (−3.91 to 0.23).070
       9wk31.08±7.8929.67±6.9029.94±76.03
      Sit-to-stand (s)
       Baseline15.88±11.2013.18±4.7114.15±6.370.07 (−1.98 to 2.12).950
       9wk15.14±9.3012.94±5.7613.28±6.67
      50-foot walk test (s)
       Baseline15.18±6.4413.72±4.3713.30±4.77−0.38 (−2.48 to 1.73).720
       9wk14.94±7.6814.32±8.3313.94±8.49
      Mean ± SDMean ± SDMean ± SDMean Difference (95% CI)
      Pain with activity
      Baseline6.02±2.235.62±2.635.65±2.461.41 (−0.45 to 3.28).140
      9wk4.20±3.424.02±2.885.62±2.84
      Night pain
      Baseline4.97±3.354.42±3.244.69±3.24−0.44 (−2.18 to 1.31).620
      9wk3.41±3.673.21±2.935.13±3.57
      Pain medication usage scale (MQS)
      Baseline5.91±4.645.31±4.875.53±5.76−0.64 (−3.76 to 2.47.680
      9wk5.20±4.774.73±4.996.49±6.36
      PGA
      9wkNo. (% improved)No. (% improved)No. (% improved)ET+MT vs Control, OR (95% CI)ET vs Control, OR (95% CI)
      27 (60)28 (65.1)5 (11.6)11.4 (3.8 to 34.5)12.5 (4.1 to 38)
      Abbreviations: CI, confidence interval; FABER, flexion, abduction, external rotation; MQS, Medication Quantification Scale; OR, odds ratio.
      Adjusted for baseline outcome and the following covariates: baseline WOMAC PF, aggregate ROM, sit-to-stand, and MQS.

      Treatment

      Twenty-two physiotherapists treated the patients in EMPART. The mean number of treatments ± SD for the ET group was 5.62 ± 1.99 and for the ET+MT group was 5.22 ± 2.31. Fifty-two (78.8%) participants of the ET group and 50 (76.9%) participants of the ET+MT group received at least 4 of their planned treatments. A total of 38 that completed HEP diaries were available for analysis: 22 (40.7%) in the ET+MT group and 16 (28.1%) in the ET group. Mean duration of aerobic exercise ± SD per week undertaken by the ET group was 4.62 ± .91 hours and for the ET+MT group was 4.1 ± 0.6 hours. Mean duration ± SD of the HEP per week was 2.97 ± .49 hours for the ET group and 3.57 ± .31 hours for the ET+MT group.

      Discussion

      Primary research aim

      This assessor-blinded multicenter RCT assessed the effectiveness of the addition of MT to an 8-week ET program for the treatment of hip OA. There was no significant difference between the ET and ET+MT groups in the majority of outcomes at 9 or 18 weeks, except patient satisfaction with outcome. Because of the number of outcomes assessed in this study, this significant finding of satisfaction may have occurred by chance. Patients reported higher satisfaction with outcome for the ET+MT group, as in other trials of MT intervention for musculoskeletal disorders.
      • Deyle G.D.
      • Allison S.C.
      • Matekel R.L.
      • et al.
      Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy procedures versus a home exercise program.
      • Bronfort G.
      • Evans R.
      • Nelson B.
      • Aker P.D.
      • Goldsmith C.H.
      • Vernon H.
      A randomized clinical trial of exercise and spinal manipulation for patients with chronic neck pain.
      This coincides with the higher (although not statistically significant) proportion of participants who reported improvement with ET+MT compared with ET (see table 3). Satisfaction with other aspects of the physiotherapy interactions was comparable, possibly because both interventions were delivered by the same physiotherapists at the same locations.
      Comparison with other similar studies is limited, because no known studies have evaluated ET with or without MT for hip OA, although a similar trial is underway in New Zealand.
      • Abbott J.H.
      • Robertson M.C.
      • McKenzie J.E.
      • Baxter G.D.
      • Theis J.C.
      • Campbell A.J.
      Exercise therapy, manual therapy, or both, for osteoarthritis of the hip or knee: a factorial randomised controlled trial protocol.
      A recent study found no differences in targeted versus full kinetic chain MT, both with additive ET for hip OA.
      • Brantingham J.W.
      • Parkin-Smith G.
      • Cassa T.K.
      • et al.
      Full kinetic chain manual and manipulative therapy plus exercise compared with targeted manual and manipulative therapy plus exercise for symptomatic osteoarthritis of the hip: a randomized controlled trial.
      Hoeksma et al,
      • Hoeksma H.L.
      • Dekker J.
      • Ronday H.K.
      • et al.
      Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.
      who compared MT head to head rather than as an adjunct to ET, found that MT alone had a superior effect on pain, function, and PGA compared with ET. Reasons for these somewhat incongruous results may relate to the dosage of MT provided; Hoeksma
      • Hoeksma H.L.
      • Dekker J.
      • Ronday H.K.
      • et al.
      Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.
      used high-velocity manipulations, whereas lower-grade mobilization techniques were used
      • Mulligan B.
      Manual Therapy, NAGs, SNAGs, MWMs etc.
      • Hengeveld E.
      • Banks K.
      Maitland's peripheral manipulation.
      in EMPART. The setting in which our RCT was located may affect external validity of these findings. The heterogeneity in clinical severity of the sample may have attenuated the treatment effect, and the more severely affected patients may not be representative of those seen in a primary care setting. Heterogeneity may also have been because of the broad age profile of the participants, which was chosen in line with other studies.
      • van Baar M.E.
      • Dekker J.
      • Oostendorp R.A.
      • et al.
      The effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized clinical trial.
      • Brantingham J.W.
      • Parkin-Smith G.
      • Cassa T.K.
      • et al.
      Full kinetic chain manual and manipulative therapy plus exercise compared with targeted manual and manipulative therapy plus exercise for symptomatic osteoarthritis of the hip: a randomized controlled trial.
      • Fernandes L.
      • Storheim K.
      • Sandvik L.
      • Nordsleten L.
      • Risberg M.A.
      Efficacy of patient education and supervised exercise vs patient education alone in patients with hip osteoarthritis: a single blind randomized clinical trial.
      Although it is possible that treatment effects may differ for patients with varying OA severity, this trial was not powered to examine subgroup effects. Larger multicenter studies are required to identify if effects of ET and MT differ depending on OA severity.

      Secondary aim

      Both groups improved in self-reported PF, aggregate ROM, and patient-perceived improvement relative to the control group in the short term (9wk). These results conflict with a meta-analysis, which found no significant short-term benefit of exercise on PF for hip OA, despite a moderate treatment effect for pain.7 Their result was considered inconclusive because of the intertrial heterogeneity and small sample size (N=205). In our study, the deterioration in WOMAC scores in the control group along with improved scores in the intervention groups accounts for the significant results obtained (see table 5). This deterioration in the control group over such a short timeframe was a surprising outcome. The unblinded status of participants may have influenced these results, introducing a cognitive measurement bias, which can occur with subjective patient-reported outcomes, where control group participants report negative outcomes because of disappointment at not receiving the target intervention.
      • Fransen M.
      • Nairn L.
      • Winstanley J.
      • Lam P.
      • Edmonds J.
      Physical activity for osteoarthritis management: a randomized controlled clinical trial evaluating hydrotherapy or Tai Chi classes.
      It may also relate to the inclusion of patients with severe symptoms, compared with other studies, which included those with mild/moderate symptoms.
      • van Baar M.E.
      • Dekker J.
      • Oostendorp R.A.
      • et al.
      The effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized clinical trial.
      • Tak E.
      • Staats P.
      • Van Hespen A.
      • Hopman-Rock M.
      The effects of an exercise program for older adults with osteoarthritis of the hip.
      The participants in this trial were recruited in a hospital setting, where the majority of patients were initially referred from primary care physicians to rheumatology and orthopedic specialists, and onward to physiotherapy. This care pathway increases the waiting time for patients to receive rehabilitation from the time of onset of symptoms.
      Other studies, which showed positive effects for exercise over no treatment, included a variety of exercise types, such as graded behavioral exercise,
      • Veenhof C.
      • Koke A.J.
      • Dekker J.
      • et al.
      Effectiveness of behavioral graded activity in patients with osteoarthritis of the hip and/or knee: a randomized clinical trial.
      Tai Chi and hydrotherapy,
      • Power M.
      • Hopayian K.
      Exposing the evidence gap for complementary and alternative medicine to be integrated into science-based medicine.
      group-based strengthening,
      • Tak E.
      • Staats P.
      • Van Hespen A.
      • Hopman-Rock M.
      The effects of an exercise program for older adults with osteoarthritis of the hip.
      and individualized exercise.
      • van Baar M.E.
      • Dekker J.
      • Oostendorp R.A.
      • et al.
      The effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized clinical trial.
      • Hoeksma H.L.
      • Dekker J.
      • Ronday H.K.
      • et al.
      Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.
      However, some of these studies included people with hip or knee OA.
      • van Baar M.E.
      • Dekker J.
      • Oostendorp R.A.
      • et al.
      The effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized clinical trial.
      • Veenhof C.
      • Koke A.J.
      • Dekker J.
      • et al.
      Effectiveness of behavioral graded activity in patients with osteoarthritis of the hip and/or knee: a randomized clinical trial.
      • Power M.
      • Hopayian K.
      Exposing the evidence gap for complementary and alternative medicine to be integrated into science-based medicine.
      Exposing people with hip or knee OA to similar interventions in the same trial may result in undetected joint-specific effects. To date, the optimal exercise approach for hip OA alone has yet to be identified.
      • Fransen M.
      • McConnell S.
      • Hernandez-Molina G.
      • Reichenbach S.
      Exercise for osteoarthritis of the hip.
      The MCID for WOMAC PF has previously been determined as 5.4.
      • Tubach F.
      • Ravaud P.
      • Baron G.
      • et al.
      Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement.
      In our trial, the mean improvement at 9 weeks was 6.25 for ET+MT and 4.21 for ET (see table 5), which suggests that the clinical significance of the improvement in EMPART is borderline.
      The influence of the therapist-patient interaction cannot be eliminated as a reason for improvements in the 2 intervention groups compared with the control group. It has been shown that interventions that include a specific therapeutic relation may contribute to the treatment effect.
      • Boutron I.
      • Moher D.
      • Altman D.G.
      • Schulz K.F.
      • Ravaud P.
      Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.
      In EMPART, although self-reported PF improved as a result of both ET and ET+MT interventions, there was no change in physical performance tests. The 50-foot walk test may have been too short in distance to detect change, because longer walk tests have been shown to be more responsive to change in people with OA,
      • Parent E.
      • Moffet H.
      Comparative responsiveness of locomotor tests and questionnaires used to follow early recovery after total knee arthroplasty.
      and assessment of a range of physical performance tasks may be preferable.
      • van Baar M.E.
      • Dekker J.
      • Oostendorp R.A.
      • et al.
      The effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized clinical trial.
      Neither intervention in this RCT had a significant impact on psychological status or general health, even though reduced quality of life and depression prevail in OA.
      • Salaffi F.
      • Carotti M.
      • Stancati A.
      • Grassi W.
      Health-related quality of life in older adults with symptomatic hip and knee osteoarthritis: a comparison with matched healthy controls.
      Similar findings occurred in other RCTs of ET for lower limb OA,
      • van Baar M.E.
      • Dekker J.
      • Oostendorp R.A.
      • et al.
      The effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized clinical trial.
      • Veenhof C.
      • Koke A.J.
      • Dekker J.
      • et al.
      Effectiveness of behavioral graded activity in patients with osteoarthritis of the hip and/or knee: a randomized clinical trial.
      • Power M.
      • Hopayian K.
      Exposing the evidence gap for complementary and alternative medicine to be integrated into science-based medicine.
      and suggests that exercise on its own does not impact the wider psychosocial manifestations of OA.
      Although the exercise program in this trial provided information on self-management principles, it did not use behavioral or cognitive approaches to empower participants. Lack of significant change may also have been limited by the outcomes used (SF-36 and HADS), because both have previously demonstrated lower responsiveness to change than OA-specific measures.
      • Hoeksma H.L.
      • Van Den Ende C.H.
      • Ronday H.K.
      • Heering A.
      • Breedveld F.C.
      Comparison of the responsiveness of the Harris Hip Score with generic measures for hip function in osteoarthritis of the hip.
      • Angst F.
      • Aeschlimann A.
      • Steiner W.
      • Stucki G.
      Responsiveness of the WOMAC osteoarthritis index as compared with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention.
      This study used a rigorous methodology, such as blinding of the outcome assessor, independent central randomization, allocation concealment, validated outcome measures, highly reliable physical measures, and intention-to-treat analysis using multiple imputation.
      Simple randomization was used over block randomization, because the recruitment locations (acute teaching hospitals in an urban area) were comparable. The principal investigator who screened all participants was an experienced musculoskeletal physiotherapist and was able to effectively and systematically screen patients for suitability and ensure that patients with primary lumbar spine pathology were excluded.

      Study limitations

      A type II error may have occurred in relation to the 2 group analysis because of failure to reach the target sample size. Post hoc power analysis based on the 131 recruited patients and accounting for the dropout rate provided a power of 73.8%, at a significance level of .05, resulting in a loss of power of <7%. Attrition rate at the 18-week follow-up was higher than the a priori estimated rate of 10%. No long-term follow-up data are presented, thus limiting the interpretation of the results. The lack of blinding of both patients and physiotherapists can also be considered a limitation, although it is well recognized that blinding is virtually impossible to achieve in nonpharmacologic trials.
      • Boutron I.
      • Tubach F.
      • Giraudeau B.
      • Ravaud P.
      Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials.
      The low return of the completed HEP diaries is also worth noting but may be related to the study design. Participants were asked to return diaries to the treating therapists in order to maintain assessor blinding. Because of the high number of treating therapists, this proved difficult to implement successfully.

      Conclusions

      This RCT demonstrated that an 8-week program of ET, with and without adjunctive MT, for people with hip OA, showed similar improvements in self-report function, ROM, and PGA at 9 weeks, which were maintained at 18 weeks. However, the clinical meaningfulness of these changes is questionable. Patient satisfaction was higher for those who received adjunctive MT. These findings highlight the benefit of physiotherapy-based exercise for those with hip OA, but no additive benefit from the use of additional MT. More research is required to identify the optimal components of rehabilitation required to target the multifaceted elements of hip OA.

      Supplier

      • a.
        Statacorp, 4905 Lakeway Dr, College Station, TX 77845.

      Acknowledgments

      We thank the treating physiotherapists in this trial: Claire Gilsenan, MSc, Aisling Brennan, MSc, Vanessa Cuddy, BSc, Breon White, MSc, Martina Fitzpatrick, MSc, Aoife Caffrey, MSc, Jennifer Eadie, MSc, Fiona Lenehan, MSc, Rachel Egginton, BSc, Fiachra McLeid, MPhySt, Donal Scanlon, MManTher, Yvette Harte, BSc, Maire-Brid Casey, MManTher, Maura O'Rahilly, BSc, Ruth McCollum, BSc, Mary Cassells, MPhysio, Grainne Quinn, BSc, Fiona Cahill, BSc, Sarah O'Driscoll, MSc, Sheila McDermott, MManTher, Julie Sugrue, MManTher, Mairead Dockery, MManTher, Sarianne Farrell, MSc, and Mhairi Claire Burke, BSc.

      Appendix 1. EMPART: Exercise and Manual Physiotherapy Arthritis Research Trial treatment protocols

      Exercise therapy protocol

      The primary objective of the exercise program is to increase hip ROM to optimize hip stability and gluteal muscle strength for function.
      Warm up: Each exercise session will consist of a warm-up exercise; 5min cycling on a static bicycle (or pedals). Patients will be positioned to maximize hip ROM without resistance or excessive discomfort.
      Stretching: Muscle balance between tight hip flexors and weak hip extensors is restored through appropriate stretching exercises. Weeks 1–8, 30-s hold, 5 repetitions, 3 times a day
      Patients can be given stretches of the 2 most restricted movements, as indicated by the baseline assessment. In total, up to 5 exercises can be given as part of the HEP, including 2 stretches. Exercises can be chosen from the list below with progression from weeks 1–8, depending on patient's severity and progression in strength.
      • List of exercises
      (Extensive description and photographs of each exercise provided in protocol for treating physiotherapists)
      • Stretches (weeks 1–8)
        • 1.
          Hip extension in supine
        • 2.
          Hip extension/abduction in supine
        • 3.
          Hamstrings stretch in sitting or supine
        • 4.
          Flexion, abduction, external rotation stretch
        • 5.
          Hip flexion in 4 point kneel
        • 6.
          Hip flexion in supine
        • 7.
          Internal rotation in 4 point kneel
        • 8.
          Internal rotation in prone

        Strengthening

      • Week 1
        • 9.
          Activation of psoas major in side-lying
        • 10.
          Activation of psoas major in supine
        • 11.
          Bent knee fall outs (external rotation control)
        • 12.
          Isometric gluteus maximus in supine
        • 13.
          Isometric gluteus medius supine—knee flexed
        • 14.
          Isometric gluteus medius supine—knee extended
        • 15.
          Isometric gluteus maximus in prone
      • Week 2
        • 16.
          Gluteus maximus prone with knee flexion
        • 17.
          Isometric hip lateral rotation prone in knee flexion
        • 18.
          Bridging in supine
        • 19.
          Gluteus maximus prone preparation for hip extension
      • Week 3
        • 20.
          Walk stance level 1
        • 21.
          Gluteus medius hip extension in prone
      • Week 4
        • 22.
          Gluteus medius turn out in side-lying
        • 23.
          Walk stance level 2
        • 24.
          Gluteus medius abduction in side-lying
        • 25.
          Gluteus medius in standing side-on at wall
        • 26.
          Double-leg wall squat
      • Weeks 5–8
        • 27.
          Pelvic lowering in standing
        • 28.
          Lateral step-up
        • 29.
          Step-ups
        • 30.
          Step-downs
        • 31.
          Double-leg squat
        • 32.
          Lunge

      Manual therapy protocol

      All treatments start with general mobilization. Choose the top 2 most restricted movements from the assessment data. Determine treatment approach on each session based on direction of restriction and pain/stiffness relation. For patients with a combined pain/stiffness pattern, determine which is the predominant feature.
      This information will be given by the outcome assessor for the first treatment. For all other treatments, this can be re-evaluated by the treating therapist. Treatment approaches chosen can vary from treatment to treatment as directions of restriction, pain, and stiffness change.
      Between 2–5 treatment techniques may be used in any 1 session for an approximate total treatment time of no more than 15min. Manual therapy must be used in at least 4 treatment sessions.
      Tabled 1
      Pain>StiffnessPain=StiffnessStiffness>Pain
      General Mobilization (all treatments start with general mobilization)
      Femoral shaft rotations

      Long Caud Gr II

      Lateral belt traction Gr II

      Long Caud Gr II

      AP supine Gr II
      Femoral shaft rotations

      Long Caud Gr II/III

      Lateral belt traction Gr II/III

      Long Caud Gr II

      AP supine Gr II
      Femoral shaft rotations

      Long Caud Gr III

      Lateral belt traction Gr III

      Long Caud Gr III

      AP supine Gr III
      Flexion-related symptoms
       APs Gr II

      MWM into flexion with belt Flex/Add Gr II

      Physiol Flex Gr II

      AP supine Gr II
      MWM into flexion with belt Flex/Add Gr II/III

      Contract/hold relax flexion

      AP supine Gr II/III
      MWM into flexion with belt

      Flex/Add Gr III/IV

      Cyriax B mobilization

      AP supine Gr III
      Extension-related symptoms
       PA in prone Gr II

      PA Side-lying Gr I/II

      Hip flexor stretch (mild/moderate)

      Long Caud prone Gr II
      PA Gr II or III

      Hip flexor stretch

      Contract relax prone, then hip extension

      Long Caud prone Gr II
      PA Gr III/IV

      Contract/hold relax extension

      MWM lateral glide in standing

      Long Caud prone Gr III
      Abduction-related symptoms
       MWM lateral traction in standing

      Physiol Abd with distraction Gr II
      MWM lateral traction in standing

      Contract/hold relax abduction

      Physiol Abd with distraction Gr II/III
      MWM lateral traction in standing

      Contract/hold relax Abduction

      Cyriax B mobilization Abd
      IR-related symptoms
       Physiol IR Gr II in supine

      MWM in hip flexion
      Physiol IR Gr II/III in supine

      MWM in hip flexion
      Physiol IR Gr III in supine

      Physiol IR Gr III in supine

      MWM in hip flexion

      MWM in 4 point kneel
      ER-related symptoms
       MWM in supine

      Physiol ER Gr II in supine
      MWM in supine

      Physiol ER Gr II/III supine/prone

      FABER stretch

      Contract/hold relax ER
      MWM in supine

      Physiol ER Gr III in supine

      FABER stretch

      MWM in 4 point kneel

      Contract/hold relax ER
      Abbreviations: Abd, abduction; Add, adduction; AP, anteroposterior; Caud, caudad; ER, external rotation; FABER, flexion, abduction, external rotation; Flex, flexion; Gr, Grade; IR, internal rotation; MWM, mobilization with movement; PA, posteroanterior; Physiol, physiologic.
      At the beginning of each session, establish how the patient's status has changed since the last visit from the following, as appropriate:
      Pain status after previous treatment: How the pain was posttreatment (if increased or decreased)? How long did the change last? Numerical Rating Scale can be used.
      Changes in functional activities (eg, walking, stairs, sit to stand).
      Medication status: Any change since last treatment?
      ROM in supine (including endfeel): Flexion/abduction/external rotation/internal rotation/extension/flexion, abduction, external rotation (FABER).
      If pain worsens for more than 24h after treatment (treatment soreness), then the intensity of the mobilization techniques should be decreased in the next session, for example, from stiffness to pain and stiffness.

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      • Correction
        Archives of Physical Medicine and RehabilitationVol. 94Issue 3
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          In the article French HP, Cusack T, Brennan A, et al, Exercise and Manual Physiotherapy Arthritis Research Trial (EMPART) for osteoarthritis of the hip: a multicenter randomized controlled trial, Arch Phys Med Rehabil 2013;94:302-14, an author was inadvertently omitted from the final manuscript.
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