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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

      Abstract

      Brantingham JW, Parkin-Smith G, Cassa TK, Globe GA, Globe D, Pollard H, deLuca K, Jensen M, Mayer S, Korporaal C. 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.

      Objective

      To determine the short-term effectiveness of full kinematic chain manual and manipulative therapy (MMT) plus exercise compared with targeted hip MMT plus exercise for symptomatic mild to moderate hip osteoarthritis (OA).

      Design

      Parallel-group randomized trial with 3-month follow-up.

      Setting

      Two chiropractic outpatient teaching clinics.

      Participants

      Convenience sample of eligible participants (N=111) with symptomatic hip OA were consented and randomly allocated to receive either the experimental or comparison treatment, respectively.

      Interventions

      Participants in the experimental group received full kinematic chain MMT plus exercise while those in the comparison group received targeted hip MMT plus exercise. Participants in both groups received 9 treatments over a 5-week period.

      Main Outcome Measures

      Western Ontario and McMasters Osteoarthritis Index (WOMAC), Harris hip score (HHS), and Overall Therapy Effectiveness, alongside estimation of clinically meaningful outcomes.

      Results

      Total dropout was 9% (n=10) with 7% of total data missing, replaced using a multiple imputation method. No statistically significant differences were found between the 2 groups for any of the outcome measures (analysis of covariance, P=.45 and P=.79 for the WOMAC and HHS, respectively).

      Conclusions

      There were no statistically significant differences in the primary or secondary outcome scores when comparing full kinematic chain MMT plus exercise with targeted hip MMT plus exercise for mild to moderate symptomatic hip OA. Consequently, the nonsignificant findings suggest that there would also be no clinically meaningful difference between the 2 groups. The results of this study provides guidance to musculoskeletal practitioners who regularly use MMT that the full kinematic chain approach does not appear to have any benefit over targeted treatment.

      Key Words

      List of Abbreviations:

      ANCOVA (analysis of covariance), CI (confidence interval), HHS (Harris hip score), MCID (minimally clinically important difference), MMT (manual and manipulative therapy), OA (osteoarthritis), OTE (Overall Therapy Effectiveness), WOMAC (Western Ontario and McMasters Osteoarthritis Index)
      IN THE UNITED STATES, mild to moderate symptomatic osteoarthritis (OA) of the hip has a prevalence of 3% to 4% of the population, affecting 12 to 30 million people.
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      Tepper S, Hochberg MC. Factors associated with hip osteoarthritis: data from the First National Health and Nutrition Examination Survey (NHANES-I). Am J Epidemiol 993;137:1081-8.

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      Various drugs are effective in treating symptomatic hip OA, but they have little effect on the progression of hip OA,
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      OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines.
      and a considerable number of patients may not tolerate the side effects of these drugs, such as gastrointestinal upset and renal dysfunction, particularly with chronic use.
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      An alternative is surgical intervention, such as joint replacement, but this is regarded as premature for mild to moderate hip OA. Therefore, manual, manipulative, and exercise therapies are emerging as viable treatment options for symptomatic hip OA where drug or surgical intervention is limited.
      Manual and manipulative therapy (MMT), exercise therapy, or combinations of both, are commonly used by musculoskeletal practitioners to treat symptomatic hip OA, particularly among those practitioners with further training in MMT.
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      A controlled, prospective pilot study into the possible effects of chiropractic manipulation in the treatment of osteoarthritis of the hip.
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      Exercise for osteoarthritis of the hip.
      However, many of these therapies have not been tested in clinical trials.
      For example, the effectiveness of exercise therapy for symptomatic hip OA appears to be equivocal, and only 1 trial has compared exercise therapy with manual therapy, reporting that manual therapy was superior.
      • Hernandez-Molina G.
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      • Felson D.T.
      Effect of therapeutic exercise for hip osteoarthritis pain: results of a meta-analysis.
      • 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.
      Yet, exercise therapy is used routinely as a first-line treatment for symptomatic hip OA by musculoskeletal practitioners, with or without additional drug therapy.
      • Zhang W.
      • Moskowitz R.
      • Nuki G.
      • et al.
      OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines.
      • Hoeksma H.L.
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      • et al.
      Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.
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      Guideline Development Group
      Care and management of osteoarthritis in adults: summary of NICE guidance.
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      Exercise therapy, manual therapy, or both, for osteoarthritis of the hip or knee: a factorial randomised controlled trial protocol.
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      • Pearson N.
      • et al.
      Population requirement for primary hip-replacement surgery: a cross-sectional study.
      The addition of MMT to exercise therapy is emerging as a promising approach to reduce the symptoms of mild to moderate hip and knee OA.
      • 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.
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      Chiropractic management of the kinetic chain for the treatment of hip osteoarthritis: an Australian case series.
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      Effectiveness of manual physical therapy and exercise in osteoarthritis of the knee.
      • MacDonald C.
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      • Hoeksma H.
      Clinical outcomes following manual physical therapy and exercise for hip osteoarthritis: a case series.
      For example, 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.
      applied MMT to the hip joint with pre- and postpassive and active assisted stretching, which was shown to be superior to exercise therapy alone. Thus, a logical next step would be to expand the work of Hoeskma and compare MMT plus exercise with MMT plus exercise and treatment of other joints in the same kinematic chain.
      Deyle et al,
      • 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.
      in patients with knee OA, applied MMT by targeting both the knee joint and other joints within the local kinematic chain, like the hip, low back, and associated soft tissues, demonstrating improvement in symptoms. This kinematic chain approach, referred to by Brantingham et al
      • Brantingham J.W.
      • Globe G.A.
      • Jensen M.L.
      • et al.
      A feasibility study comparing two chiropractic protocols in the treatment of patellofemoral pain syndrome.
      as the “full kinematic chain” approach, where joints and soft tissues within the kinematic chain of the affected joint are also treated, is often used by musculoskeletal practitioners who offer MMT in clinical practice.
      • 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.
      • Brantingham J.W.
      • Globe G.A.
      • Jensen M.L.
      • et al.
      A feasibility study comparing two chiropractic protocols in the treatment of patellofemoral pain syndrome.
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      Chiropractic treatment of lower extremity conditions: a literature review.
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      Comparison of physiotherapy, manipulation, and corticosteroid injection for treating shoulder complaints in general practice: randomised, single blind study.
      Even though the full kinematic chain approach reflects a natural extension of hip MTT in clinical practice, the speculated benefit over targeted hip MMT has not yet been demonstrated.
      Thus, the purpose of this study was to determine the short-term effectiveness of full kinematic chain MMT plus exercise compared with targeted hip MMT plus exercise for symptomatic mild to moderate hip OA.
      • Abbott J.H.
      • Robertson M.C.
      • McKenzie J.E.
      • et al.
      Exercise therapy, manual therapy, or both, for osteoarthritis of the hip or knee: a factorial randomised controlled trial protocol.
      • French H.P.
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      • Brennan A.
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      Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial.
      • Brantingham J.W.
      • Globe G.
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      • Hoskins W.
      Manipulative therapy of lower extremity conditions: expansion of a literature review.
      • Bronfort G.
      • Haas M.
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      Effectiveness of manual therapies: the UK evidence report.
      The objective was to compare the experimental treatment (full kinematic chain MMT plus exercise) with the comparison treatment (targeted hip MMT plus exercise) in terms of hip-related symptoms in the short term, with 3-month follow-up. The research hypothesis was that the experimental treatment (full kinematic chain MMT plus exercise) would result in greater change in outcome measure scores over the comparison group (targeted hip MMT plus exercise) in terms of hip-related symptoms.

      Methods

      Setting, Practitioners, and Participants

      This study was implemented across 2 chiropractic outpatient teaching clinics. Thirteen senior chiropractic interns, under the supervision of 3 experienced chiropractors with a special interest in extremity joint disorders, participated as treating practitioners in this trial. The 13 practitioners provided treatment to participants in both treatment groups, respectively, and were not blind to the treatments provided in either intervention group. However, the practitioners did not collect data or have access to the collected data, in order to reduce the risk of bias.
      Participants were recruited through convenience sampling over a 2-year period where candidates presenting with hip pain were screened by phone or in person for eligibility. Eligible patients were then invited to participate in the study, but were allowed a cooling-off period of at least 5 days to consider volunteering for the study without feeling pressured to do so. One hundred and eleven eligible patients volunteered for the study, were consented, and then randomly allocated to a treatment group.

      Selection Criteria

      Inclusion criteria

      All eligible participants had a diagnosis of symptomatic mild to moderate hip OA based on the diagnostic criteria of the American College of Rheumatology and the Kellgren-Lawrence grade for hip OA; suitable grades for this study were grades 0 to 3.
      • Altman R.
      Criteria for classification of clinical osteoarthritis.
      • Kellgren J.H.
      • Lawrence J.S.
      Radiological assessment of osteo-arthrosis.
      This diagnosis was reached after thorough assessment of each eligible participant at their first encounter by a registered chiropractor.
      The inclusion criteria were: (1) hip pain with less than 15° of internal rotation and less than 115° flexion or hip pain with greater than 15° internal rotation with morning stiffness of less than 60 minutes; (2) a Kellgren-Lawrence grade of 0 to 3 on plain-film radiograph; (3) age of 40 years and older and 85 years or younger;
      • 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.
      • Fish D.
      • Kretzmann H.
      • Brantingham J.W.
      • Globe G.
      • Korporaal C.
      • Moen J.
      A randomized clinical trial to determine the effect of combining a topical capsaicin cream and knee joint mobilization in the treatment of osteoarthritis of the knee.
      • 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.
      • Altman R.
      • Alarcón G.
      • Appelrouth D.
      • et al.
      The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip.
      (4) ability to stand and walk without assistance for most (≥three-quarters) of the day, as keeping active and performing exercises would otherwise be difficult; and (5) a fall risk assessment: one leg standing test of more than 5 seconds to qualify for the Berg Balance Scale, and a Berg Balance Scale score of more than 45.

      Exclusion criteria

      Exclusion criteria included: (1) Kellgren-Lawrence grade 4 hip degenerative changes on plain-film radiograph, indicating severe hip OA and being more amenable to surgical intervention; (2) possibility of serious pathologic or psychiatric disorders; (3) possibility of a disorder that would prevent the participant performing exercises or receiving MMT; (4) history of lumbar herniated disk or low back injury, as the clinical outcome would be very different in such patients; (5) very poor scores for the Berg Balance Scale (ie, <5s and score of <45); and (6) bilateral symptomatic hip OA.
      This project received approval from the Institutional Review Board of Cleveland College of Chiropractic, USA, and the Research Ethics Committee of Macquarie University, Australia.

      Interventions

      Comparison group: targeted hip MMT plus exercise

      The treatment comprised of targeted hip MMT (using high-velocity, low-amplitude thrust-type manipulation) with pre- and posttreatment stretch of the same hip, provided at each treatment session (appendix 1, see fig 1) .
      • 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.
      • Hoskins W.
      • McHardy A.
      • Pollard H.
      • Windsham R.
      • Onley R.
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Brantingham J.W.
      • Globe G.
      • Pollard H.
      • Hicks M.
      • Korporaal C.
      • Hoskins W.
      Manipulative therapy of lower extremity conditions: expansion of a literature review.
      • Bronfort G.
      • Haas M.
      • Evans R.
      • Leiniger B.
      • Triano J.
      Effectiveness of manual therapies: the UK evidence report.
      General advice for safely increasing exercise (eg, walking, progressing toward aerobic exercise daily) was only formally provided after week 5 (ninth visit)—participants were advised to keep active and slowly increase their exercise routine, as able. No treatment was provided between the ninth visit (final session in week 5) and 3-month follow-up.
      Figure thumbnail gr1
      Fig 1Demonstration of manipulation of the hip joint, in a position of axial elongation and internal rotation while tolerated by the patient.

      Experimental group: full kinematic chain MMT plus exercise

      In addition to targeted hip MMT, joint mobilization and joint manipulation were applied to joints and soft tissues in the kinematic chain on the side of the affected hip.
      • Brantingham J.
      • Williams A.
      • Parkin-Smith G.
      • Weston P.
      • Wood T.
      A controlled, prospective pilot study into the possible effects of chiropractic manipulation in the treatment of osteoarthritis of the hip.
      • MacDonald C.
      • Whitman J.
      • Cleland J.
      • Smith M.
      • Hoeksma H.
      Clinical outcomes following manual physical therapy and exercise for hip osteoarthritis: a case series.
      • Brantingham J.W.
      • Globe G.A.
      • Jensen M.L.
      • et al.
      A feasibility study comparing two chiropractic protocols in the treatment of patellofemoral pain syndrome.
      • Hoskins W.
      • McHardy A.
      • Pollard H.
      • Windsham R.
      • Onley R.
      Chiropractic treatment of lower extremity conditions: a literature review.
      • Brantingham J.W.
      • Globe G.
      • Pollard H.
      • Hicks M.
      • Korporaal C.
      • Hoskins W.
      Manipulative therapy of lower extremity conditions: expansion of a literature review.
      • Brantingham J.W.
      • Globe G.
      • Cassa T.
      • et al.
      A single-group pre-test post-test design using full kinetic chain manipulative therapy with rehabilitation in the treatment of 18 patients with hip osteoarthritis.
      Treatment was applied to areas, such as the low back, knee, and ankle, at the discretion of the treating practitioner (see appendix 1, see fig 1).
      • 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.
      • 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.
      • Brantingham J.W.
      • Globe G.A.
      • Jensen M.L.
      • et al.
      A feasibility study comparing two chiropractic protocols in the treatment of patellofemoral pain syndrome.
      • Brantingham J.W.
      • Globe G.
      • Cassa T.
      • et al.
      A single-group pre-test post-test design using full kinetic chain manipulative therapy with rehabilitation in the treatment of 18 patients with hip osteoarthritis.
      General advice was provided in the same fashion as for the comparison group, with no additional treatment provided between the ninth visit (week 5) and 3-month follow-up.

      Treatment Period

      Participants in both the experimental group and the standard group received 9 treatments over a 5-week period, with follow-up at 3 months.

      Outcome Measures

      The primary outcome measure was the Western Ontario and McMasters Osteoarthritis Index (WOMAC), a 24-question survey used to assess and monitor hip OA, including the parameters of pain, joint stiffness, and function.
      • Bellamy B.
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      Validation of WOMAC: a health status instrument for measuring clinical important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip and knee.
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      The WOMAC Knee and Hip Osteoarthritis Indices: development, validation, globalization and influence on the development of the AUSCAN Hand Osteoarthritis Indices.
      • Barr S.
      • Bellamy N.
      • Buchanan W.W.
      • et al.
      A comparative study of signal versus aggregate methods of outcome measurement based on the WOMAC Osteoarthritis Index Western Ontario and McMaster Universities Osteoarthritis Index.
      Each parameter (question) was scored out of 100, with a maximum total score of 2400 (mm); for example pain was scored on a visual analog scale out of 100mm.
      The secondary outcome measures were (1) the Harris hip score (HHS), a 10-item scale used to score hip OA, including pain and hip function,
      • 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.
      • MacDonald C.
      • Whitman J.
      • Cleland J.
      • Smith M.
      • Hoeksma H.
      Clinical outcomes following manual physical therapy and exercise for hip osteoarthritis: a case series.
      • Bellamy B.
      • Buchanon W.W.
      • Goldsmith C.H.
      • Campbell J.
      • Stitt L.
      Validation of WOMAC: a health status instrument for measuring clinical important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip and knee.
      • 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.
      • Harris W.H.
      • Kirmit L.
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      • Sen A.
      • Gocen Z.
      The reliability of hip scoring systems for total hip arthroplasty candidates: assessment by physical therapists.
      where a score of 90 to 100 is excellent, 80 to 90 is good, 70 to 79 is fair, 60 to 69 is poor, and below 60 is a failed result; and 2 the Overall Therapy Effectiveness (OTE) tool, which measures patient-perceived satisfaction and improvement with care,
      • 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.
      • Juniper E.F.
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      Determining a minimal important change in a disease-specific Quality of Life Questionnaire.
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      Patient-reported gastrointestinal symptom burden and health-related quality of life following conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium.
      with the 2 sections of the OTE on a 15-point and 7-point scale, respectively.
      The WOMAC index is a valid and reliable measure of changes in pain and function, used in various hip OA trials, where a 20% overall change in score (ie, 480/2400) is reported as being clinically meaningful. For the HHS, a clinically meaningful posttreatment score appears to be an increase in score of more than 4 points (40%).
      • Bellamy B.
      • Buchanon W.W.
      • Goldsmith C.H.
      • Campbell J.
      • Stitt L.
      Validation of WOMAC: a health status instrument for measuring clinical important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip and knee.
      • Bellamy N.
      The WOMAC Knee and Hip Osteoarthritis Indices: development, validation, globalization and influence on the development of the AUSCAN Hand Osteoarthritis Indices.
      • Barr S.
      • Bellamy N.
      • Buchanan W.W.
      • et al.
      A comparative study of signal versus aggregate methods of outcome measurement based on the WOMAC Osteoarthritis Index Western Ontario and McMaster Universities Osteoarthritis Index.
      • Kirmit L.
      • Karatosun V.
      • Unver B.
      • Bakirhan S.
      • Sen A.
      • Gocen Z.
      The reliability of hip scoring systems for total hip arthroplasty candidates: assessment by physical therapists.
      • 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.
      • Farrar J.T.
      • Young Jr, J.P.
      • LaMoreaux L.
      • Werth J.L.
      • Poole R.M.
      Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale.
      The OTE data were amenable to being dichotomized into 2 categories, being improved and not improved, with a 30% or greater change in mean scores from baseline to the final treatment considered clinically meaningful and, therefore, improved.
      • Felson D.T.
      Epidemiology of hip and knee osteoarthritis.
      • Farrar J.T.
      • Young Jr, J.P.
      • LaMoreaux L.
      • Werth J.L.
      • Poole R.M.
      Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale.
      Various authors report that a 30% of more change in scores from baseline to the final treatment for patient satisfaction and overall perception of improvement is clinically meaningful.
      • Juniper E.F.
      • Guyatt G.H.
      • Willan A.
      • Griffith L.E.
      Determining a minimal important change in a disease-specific Quality of Life Questionnaire.
      • O'Meara E.
      • Lewis E.
      • Granger C.
      • et al.
      Patient perception of the effect of treatment with candesartan in heart failure Results of the Candesartan in Heart failure: assessment of reduction in mortality and morbidity (CHARM) programme.
      • Chan L.
      • Mulgaonkar S.
      • Walker R.
      • Arns W.
      • Ambühl P.
      • Schiavelli R.
      Patient-reported gastrointestinal symptom burden and health-related quality of life following conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium.
      • Farrar J.T.
      • Young Jr, J.P.
      • LaMoreaux L.
      • Werth J.L.
      • Poole R.M.
      Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale.
      • Guyatt G.H.
      • Juniper E.F.
      • Walter S.D.
      • Griffith L.E.
      • Goldstein R.S.
      Interpreting treatment effects in randomised trials.

      Randomization and Data Management

      Randomization was conducted using a random numbers process where a sequence of random numbers with sequence boundaries was generated using computer software, using an atmospheric noise approach (www.random.org). This randomization process was conducted by 1 of the authors who did not participate as a clinician in the trial or collect data. Each random treatment assignment was placed in a sealed opaque envelope, producing a series of sequentially numbered sealed envelopes, thus conferring allocation concealment. As each volunteer consented to participate, the treating intern then opened an envelope and identified the treatment group to which the participant was assigned. The data were collected and kept separate from the clinical records to reduce the chance of treatment contamination.
      • Saghaei M.
      Random allocation software for parallel group randomized trials.

      Sample Size Calculation

      The sample size was estimated using data from published trials investigating treatment for hip OA using the WOMAC index as the primary outcome measure.
      • Brantingham J.
      • Williams A.
      • Parkin-Smith G.
      • Weston P.
      • Wood T.
      A controlled, prospective pilot study into the possible effects of chiropractic manipulation in the treatment of osteoarthritis of the hip.
      • 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.
      • Cochrane T.
      • Davey R.C.
      • Matthes Edwards S.M.
      Randomised controlled trial of the cost-effectiveness of water-based therapy for lower limb osteoarthritis.
      • Allyson J.C.
      • Voaklander D.C.
      • Johnston D.W.C.
      • Suarez-Almazor M.
      The effect of age on pain, function, and quality of life after total hip and knee arthroplasty.
      • Angst F.
      • Aeschlimann A.
      • Michel B.A.
      • Stucki G.
      Minimal clinically important rehabilitation effects in patients with osteoarthritis of the lower extremities.
      A 30% (or 720/2400) difference in the WOMAC index was considered meaningful in this trial for estimating sample sizes, being a more conservative figure than some published estimates of around 20% (or 480/2400).
      • 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.
      • Chan L.
      • Mulgaonkar S.
      • Walker R.
      • Arns W.
      • Ambühl P.
      • Schiavelli R.
      Patient-reported gastrointestinal symptom burden and health-related quality of life following conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium.
      • 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.
      • Farrar J.T.
      • Young Jr, J.P.
      • LaMoreaux L.
      • Werth J.L.
      • Poole R.M.
      Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale.
      • Guyatt G.H.
      • Juniper E.F.
      • Walter S.D.
      • Griffith L.E.
      • Goldstein R.S.
      Interpreting treatment effects in randomised trials.
      The projected sample size to yield 80% power of detecting a difference at a 5% level of significance (2-tailed test; G*Power 3.0 softwarea) using a 3-point difference in outcome measures (effect size index=.29) was 50 participants per group. Allowing for a 15% dropout rate,
      • Portney L.
      • Watkins P.
      Foundations of clinical research: applications to practice.
      • Haneline M.
      Evidence-based chiropractic practice.
      60 participants per group were intended to be recruited (N≈120).
      • Portney L.
      • Watkins P.
      Foundations of clinical research: applications to practice.
      • Haneline M.
      Evidence-based chiropractic practice.
      • Faul F.
      • Erdfelder E.
      • Lang A.G.
      • Buchner A.
      G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences.
      • Faul F.
      • Erdfelder E.
      • Buchner A.
      • Lang A.G.
      Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses.

      Data Analysis

      Intention-to-treat analysis was performed by replacing missing data using a multiple imputations method (WinMICE prototype version 0.1b), and statistically comparing the original datasets with the datasets with missing data inserted. The calculations were performed using a multilevel regression model that created 5 multilevel imputations by the software.
      • Donders A.R.
      • van der Heijden G.J.
      • Stijnen T.
      • Moons K.G.
      Review: a gentle introduction to imputation of missing values.
      • Moons K.G.
      • Donders R.A.
      • Stijnen T.
      • Harrell Jr, F.E.
      Using the outcome for imputation of missing predictor values was preferred.
      The missing data were replaced with the mean value of the 5 multilevel imputations.
      • Donders A.R.
      • van der Heijden G.J.
      • Stijnen T.
      • Moons K.G.
      Review: a gentle introduction to imputation of missing values.
      • Moons K.G.
      • Donders R.A.
      • Stijnen T.
      • Harrell Jr, F.E.
      Using the outcome for imputation of missing predictor values was preferred.
      Datasets were amenable to the F test (analysis of covariance, [ANCOVA]) and t test.
      • Portney L.
      • Watkins P.
      Foundations of clinical research: applications to practice.
      • Moore A.
      Evidence based thinking about healthcare. Oxford c 1994-2007. Number needed to treat.
      Primary analysis was between-group analysis of WOMAC data, while secondary analysis was between-group analysis of the HHS and OTE data. In both primary and secondary analyses, weighted ANCOVA was used because ANCOVA accounts for the possibility of undetected differences between sample means at baseline and accommodated for possible data variance caused by the selected covariates of patient age and duration of symptoms. If a significant difference(s) was detected between datasets using ANCOVA, Tukey honestly significant difference analysis was conducted automatically to establish where the difference(s) lay.
      Within-group OTE data were amenable to dichotomization, producing 2 categories—improved and not improved—where a 30% change in score (720/2400) for WOMAC was the threshold for dichotomization. The frequency of within-group dichotomized data was then represented as a ratio (in %) of cases that either improved or did not improve.
      All statistical analyses were conducted, including confidence intervals (CIs), at a 95% confidence level (α=.05), using 2-tailed tests
      • Portney L.
      • Watkins P.
      Foundations of clinical research: applications to practice.
      • Haneline M.
      Evidence-based chiropractic practice.
      (SPSS version 12c) and G*Power software.
      • Faul F.
      • Erdfelder E.
      • Lang A.G.
      • Buchner A.
      G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences.
      • Faul F.
      • Erdfelder E.
      • Buchner A.
      • Lang A.G.
      Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses.
      The estimated differences in between-group means were explored to identify any clinically meaningful change as a result of the interventions. A difference in between-group means of 20% or more in the primary outcome measure,
      • 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.
      • Ostelo R.W.
      • Deyo R.A.
      • Stratford P.
      • et al.
      Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change.
      representing a minimally clinically important difference (MCID) of 20%, alongside a between-group effect size index of .20 or more in the primary outcome measure, was considered clinically meaningful in this trial. Differences in between-group mean scores of less than 20% or an effect size of less than .20 were considered too small to infer a clinical benefit of 1 treatment over the other.
      • Portney L.
      • Watkins P.
      Foundations of clinical research: applications to practice.

      Results

      Patient Characteristics and Baseline Data

      The flow of participants is represented in figure 2 (Consolidated Standards of Reporting Trials). Of the 398 subjects screened, 237 were assessed, with 111 eligible participants volunteering for the study. Eligible volunteers provided written informed consent prior to random allocation. Fifty-eight participants were randomized to the comparison group (targeted hip MMT plus exercise) and 53 to the experimental group (full kinematic chain MMT plus exercise). Blind assessment and data collection was carried out at both clinical sites according to a previously used format.
      • Brantingham J.W.
      • Globe G.A.
      • Jensen M.L.
      • et al.
      A feasibility study comparing two chiropractic protocols in the treatment of patellofemoral pain syndrome.
      Ten participants either dropped out of the study or had missing data (3 in the comparison group and 7 in the experimental group), with the data from 101 participants available for initial analysis.
      Figure thumbnail gr2
      Fig 2Patient flow (Consolidated Standards of Reporting Trials diagram).
      Each appointment was 30 minutes in duration, meaning that the overall treatment dose per treatment session was 30 minutes, with each participant in both groups receiving a total of 4.5 hours of treatment over the respective treatment periods.
      Examination of the descriptive and patient characteristics suggests that the 2 groups were similar at baseline (table 1). Baseline scores for the primary outcome measure indicated that the majority of participants in both groups had unilateral moderate symptomatic hip OA (see table 1), where the WOMAC scores at baseline for the comparison group was 1163 (48.5%) and 1148 (47.8%) for the experimental group. The HSS scores were 62 (62%, implying 38% disability) for both groups.
      Table 1Sample Characteristics–Descriptive Statistics and Group Comparison
      VariableComparison Group (targeted MMT plus exercise) n=58Experimental Group (full kinetic chain MMT plus exercise) n=53
      Age (y)62.8±10.363.3±10.7
      Age≥50y, number of cases (% of cases)51 (88)49 (92)
      Sex (% of cases)
       Men4544
       Women5556
      BMI23.9±3.624.2±3.8
      Duration of symptoms (d)67±8650±66
      45–9032–68
      Duration of symptoms
      Number of cases (% of cases)
       ≤42d32±5534±64
       43–168d23±402±4
       >168d3±517±32
      Radiographic findings (KL grades)
      KL grades: grade 0, none; grade 1, doubtful; grade 2, minimal; and grade 3, moderate.
      (% of cases)
       02630
       13021
       21925
       32524
      ACR criteria (% of cases)
      ACR criteria: criteria A, hip pain and <15° internal rotation and <115° flexion; criteria B, hip pain with >15° internal rotation causing hip pain and morning stiffness <60min.
       Criteria A3442
       Criteria B6658
      Baseline scores
       WOMAC (mm)
      WOMAC scores in millimeters out of a total possible score of 2400.
      1163±4151148±456
      1052–12711024–1276
       HHS
      HHS scores out of a total possible score of 100.
      62±962±12
      59–6458–65
      NOTE. Values are mean ± SD, 95% CI, or as otherwise indicated.
      Abbreviations: ACR, American College of Rheumatology; BMI, body mass index; KL, Kellgren-Lawrence.
      low asterisk KL grades: grade 0, none; grade 1, doubtful; grade 2, minimal; and grade 3, moderate.
      ACR criteria: criteria A, hip pain and <15° internal rotation and <115° flexion; criteria B, hip pain with >15° internal rotation causing hip pain and morning stiffness <60min.
      WOMAC scores in millimeters out of a total possible score of 2400.
      § HHS scores out of a total possible score of 100.

      Intention-to-Treat Analysis

      Examination of all the datasets in this trial revealed that 7% of the data were missing, which were accounted for by imputing missing values,
      • Rubin D.B.
      Multiple imputation for nonresponse in surveys.
      with the datasets with missing data replaced being used for all statistical analyses.

      Data Analysis

      Between-group statistical analysis of the primary outcome (WOMAC) and the secondary outcomes (HHS and OTE) did not reveal any significant differences (weighted ANCOVA; P=.45, P=.79, P=.88, respectively) between the 2 intervention groups on primary and secondary analysis, implying similar scores in both groups (Table 2, Table 3).
      Table 2Comparison of Scores of the Comparison Group (targeted hip MMT plus exercise) With the Experimental Group (full kinematic chain MMT plus exercise) for the WOMAC and HHS at Week 5 and 3-Month Follow-Up
      Week 53-mo Follow-Up
      Outcome MeasureMean ± SD or95% CIMean ± SD or95% CIAnalysis P
      WOMAC (mm)
      WOMAC scores in millimeters out of a total possible score of 2400.
       Total Score
        Comparison group618±405662±464.45 (ANCOVA)
         (targeted MMT plus exercise)507–720535–779
        Experimental group740±561764±567
         (full kinematic chain MMT plus exercise)590–899613–925
       Subscales Scores
      Pain
        Comparison group117±80136±100.58 (t test)
      90–144112–160
        Experimental group126±88122±73.10 (t test)
      76–13669–135
        Stiffness
        Comparison group62±4265±44.98 (t test)
      48–7650–80
        Experimental group62±4868±38.37 (t test)
      46–7855–81
      HHS
      HHS scores out of a total possible score of 100.
       Comparison group71±1371±13.79 (ANCOVA)
        (targeted MMT plus exercise)68–7567–74
       Experimental group72±1769±18
        (full kinematic chain MMT plus exercise)66–7664–74
      low asterisk WOMAC scores in millimeters out of a total possible score of 2400.
      HHS scores out of a total possible score of 100.
      Table 3Group Comparison–OTE Scores, Based on Dichotomised Data Where the Decision-Making Threshold Value is a 30% Change in Score for Dichotomization
      GroupWeek 5(% of cases)3-mo Follow-Up(% of cases)Analysis of Data From Week 5 (P)Analysis of Data From 3-mo Follow-Up (P)
      Comparison group (targeted MMT plus exercise)
       Improved8972
       Not improved1128.88.86
      Experimental group (full kinematic chain MMT plus exercise)
       Improved7966
       Not improved2134
      There was minimal difference (range, 1%–5%; <MCID value of 20%) between groups when comparing estimated means at the 5-week and 3-month follow-up points.
      Figure 3 shows the trend in outcomes for the 2 groups over the treatment period (baseline, week 5, and 3-month follow-up), providing insight into potential within-group outcomes, although no presumptions concerning effectiveness of the individual treatment groups can be inferred, because no control or placebo group is included in this trial. The change in WOMAC scores (out of 2400) from baseline to the ninth consultation (week 5), baseline to the 3-month follow-up, and ninth consultation (week 5) to the 3-month follow-up for the comparison group (MMT plus exercise) for the WOMAC was 545±442 (95% CI, 431–659), 501±474 (95% CI, 379–623), and −44±252 (95% CI, −109 to 21), respectively. The scores for the experimental group (full kinematic chain MMT plus exercise) at the same timepoints were 408±432 (95% CI, 242–574), 383±467 (95% CI, 255–511), and −24±259 (95% CI, −94 to 46), respectively.
      Figure thumbnail gr3
      Fig 3Trends in outcomes within each treatment group (WOMAC and HHS). The lines are the plotted baseline, week 5, and 3-month follow-up mean scores. The graphs, therefore, provide insight as to the trend in outcomes.
      The mean residual scores after the treatment period (week 5) are offered in table 2.

      Discussion

      To our knowledge, this is the first randomized controlled trial comparing full kinematic chain MMT plus exercise with targeted hip MMT plus exercise for symptomatic mild to moderate hip OA, with a 3-month follow-up.
      The outcomes of this trial demonstrate that there were neither statistically significant nor clinically meaningful differences when comparing the experimental group (full kinematic chain MMT plus exercise) with the comparison group (targeted hip MMT plus exercise). The distinctive contribution of this trial is that, particularly for those musculoskeletal practitioners who regularly use manual and manipulative therapies (in the form of joint and/or soft tissue manipulation), it provides guidance regarding the choice of MMT approach; in this case, full kinematic chain MMT does not appear have any benefit over targeted hip MMT.
      The within-group changes observed in trial are consistent with the positive outcomes reported with the use of MMT for hip OA in published trials.
      • Brantingham J.
      • Williams A.
      • Parkin-Smith G.
      • Weston P.
      • Wood T.
      A controlled, prospective pilot study into the possible effects of chiropractic manipulation in the treatment of osteoarthritis of the hip.
      • 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.
      • MacDonald C.
      • Whitman J.
      • Cleland J.
      • Smith M.
      • Hoeksma H.
      Clinical outcomes following manual physical therapy and exercise for hip osteoarthritis: a case series.
      • Thorman P.
      • Dixner A.
      • Sundberg T.
      Effects of chiropractic care on pain and function in patients with hip osteoarthritis waiting for arthroplasty: a clinical pilot trial.
      In addition, this study shows that the outcomes in both groups appear to be retained up to the 3-month follow-up without further treatment, which is unique to this study. However, these results only provide insight into the potential benefit of MMT and are not evidence of effectiveness.

      Study Limitations

      The limitation of this trial is that there is no control group featuring no treatment or a placebo treatment. Therefore, the natural history of symptomatic hip OA, which is often characterized by fluctuating signs and symptoms, alongside the potential effect of the Hawthorne phenomenon, may account for some of the improvement seen in each treatment group.
      Also, as a pragmatic trial, this study also does not permit conclusions to be drawn about the effect of individual treatments used as part of the treatment package in each group.
      This study excluded patients that had severe hip OA (Kellgren-Lawrence grade 4), because such cases are more amenable to surgical intervention rather than conservative treatment. However, 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.
      reported meaningful improvements in participants with grade 4 hip OA, implying that this grade of hip OA should be considered for inclusion in future studies.

      Conclusions

      There were no statistically significant or clinically meaningful differences in the primary or secondary outcome measure scores when comparing full kinematic chain MMT plus exercise with targeted hip MMT plus exercise for mild to moderate symptomatic hip OA. The results of this study provides guidance to musculoskeletal practitioners who regularly use MMT that full kinematic chain approach does not appear to have any benefit over targeted treatment.
      • a
        G*Power 3.0 software, 40225 Heinrich-Heine-University Dusseldorf, Germany.
      • b
        TNO Quality of Life, P.O. Box 2215, 2301 CE Leiden, The Netherlands
      • c
        SPSS Inc, 233 S Wacker Dr, 11th Fl, Chicago, IL 60606.

      Acknowledgment

      We thank Cheryl Hawk, DC, PhD, for her help, insights, and suggestions.

      APPENDIX 1. Glossary

      MMT: Manual and manipulative therapy
      Active-assisted stretch: a stretch or stretching technique that is accomplished by the operator with conscious assistance by the participant (patient).
      End feel (or end play): discrete, short-range movements of a joint independent of muscular action, determined by springing the joint at the limit of its passive range of motion.
      Mobilization: a form of manipulation applied within the physiologic passive range of motion, without thrust.
      Manipulation: a form of manipulation that involves a directed thrust applied to a joint through the physiologic passive range of motion, without exceeding the anatomic limit.
      Mortise separation and plantar snap: specific manipulative techniques that include a thrust to the mortise joint and tarsal joints, respectively.

      Hip OA Treatments

      Comment: All MMT and exercise procedures should take into account patient age, stiffness, abilities, tolerance, and contraindications before executing the hip axial elongation with high-velocity, low-amplitude, thrust-type manipulation (a distractive impulse pull) or passive and active-assistive stretch.

      Control Treatment: Targeted Hip MMT Plus Exercise

      • 1
        The procedure begins with premanipulative stretches of muscles around the affected hip joint, which may include psoas, quadriceps, hamstrings, tensor fasciae latae, gracilis, long adductors, and sartorius.
      • 2
        Premanipulative stretching is followed by axial elongation of the affected limb in slight hip abduction and hip flexion of about 30°, immediately followed by the application of a high-velocity low-amplitude, thrust-type manipulation (traction pull/thrust) in this position.
      • 3
        This is then followed by active assisted stretch of tight muscles around the hip.
      • 4
        Thereafter, hip flexion and hip end feel spring of the affected limb is assessed, and if not improved (ie, approximating or similar flexion and end-feel as the unaffected hip), the procedure is repeated. With the addition of some internal rotation, where:
      • 5
        Axial elongation of the affected limb in slight hip abduction and hip flexion of about 30° and with some internal rotation of the hip joint, immediately followed by the application of a high-velocity low-amplitude, thrust-type manipulation (traction pull/thrust) in this position. The addition of some internal rotation acts to “tighten up” the hip joint thereby approximating the close packed position of the joint.
      • 6
        This is then followed by active-assisted stretch of tight muscles around the hip.
      • 7
        Thereafter, hip flexion and hip end feel spring of the affected limb is assessed and if not improved (ie, approximating or similar flexion and end-feel of the unaffected hip), then repeat procedure (5) as required.
      • 8
        The procedure may be performed up to 5 times, checking hip flexion and end feel spring in flexion after each procedure. Stop applying the procedure when hip flexion and end feel spring in flexion of the affected limb is similar or the same as that of the unaffected hip joint, or after 5 procedures, whichever comes first; and
      • 9
        The treatment included pain-free exercise, gradually increasing the exercises within tolerance. Participants were advised to keep active and slowly increase their exercise routine, as able.

      Experimental Treatment: Full Kinematic Chain MMT

      Targeted MMT is applied to the affected hip joint in the manner described previously for the control group. MMT to other joints in the kinematic chain are only provided if the patient is able to tolerate the procedure and does not demonstrate contraindications to MMT.
      Additional MMT is applied, as indicated, where:
      • 1
        Joint mobilization and/or manipulation is applied to the lumbosacral and/or sacroiliac joints using joint mobilization techniques and high- or low-velocity, low-amplitude, thrust-type manipulation(s)appropriate.
      • 2
        Mobilize and/or manipulate the ipsilateral knee by applying flexion and extension mobilization, gentle axial elongation, and patellar mobilization, after which and add controlled end-range of motion thrusts (high-velocity, low-amplitude, thrust-type manipulation) if tolerated by the patient (including, for example, forced knee flexion to increase A-P or P-A proximal fibular joint glide).
      • 3
        Mobilize and/or manipulate the ipsilateral ankle by applying mortise separation (axial elongation of the ankle joint with and without an A-P scoop to increase talar A-P glide; or using a supine, dorsiflexed ankle with A-P mobilization of the distal tibia to increase ankle dorsiflexion and talar A-P glide), and A-P distal fibula mobilization and manipulation.
      • 4
        Additional foot mobilization and/or manipulation may be applied, as indicated, such as STJ eversion, inversion, or axial elongation, D-P small tarsal(s) mobilization or manipulation (D-P thrust on small tarsals applied like a mortise separation), forefoot figure of 8 mobilization, intermetatarsal glide mobilization, axial elongation of the metatarsophalangeal joints; and
      • 5
        The treatment included pain-free exercise, gradually increasing the exercises within tolerance. Participants were advised to keep active and slowly increase their exercise routine, as able.
      The core set of full kinematic chain MMT procedures is summarized in the list below:
      • 1
        Hip axial elongation manipulation
      • 2
        Spinal or SI manipulation
      • 3
        Knee flexion and extension mobilization
      • 4
        Knee axial elongation manipulation (mobilization or manipulation)
      • 5
        Patellar mobilization
      • 6
        Mortise separation (mobilization or manipulation of cuboid, etc)
      • 7
        A-P distal fibula
      • 8
        STJ eversion, inversion
      • 9
        D-P small tarsals (like mortice separation)
      • 10
        Forefoot figure of 8 mobilizations
      • 11
        Intermetatarsal glide (no forced end ROM thrust with knee OA)
      • 12
        Axial elongation of the toes or MTPJs
      • 13
        Plantar snap move (plantar to dorsal)
      • 14
        If indicated proximal fibular mobilization or HVLA adjustment
      Other MMT/adjustments as carefully indicated and inversion and axial elongation
      Abbreviations: A-P, anterior to posterior; HVLA, manipulation; MTPJ, metatarsophalangeal joint; P-A, posterior to anterior; SI, sacroiliac; STJ, subtalar joint.

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