Prosthetics, orthotics, devices| Volume 90, ISSUE 4, P701-706, April 2009

Effectiveness of Prefabricated and Customized Foot Orthoses Made From Low-Cost Foam for Noncomplicated Plantar Fasciitis: A Randomized Controlled Trial


      Baldassin V, Gomes CR, Beraldo PS. Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for noncomplicated plantar fasciitis: a randomized controlled trial.


      To evaluate the effectiveness of prefabricated and customized foot orthoses made from low-cost foam (ethylene vinyl acetate [EVA]) in plantar fasciitis.


      Double-blinded randomized controlled trial.


      Public rehabilitation referral medical center.


      One hundred forty-two adults (75% women) with plantar fasciitis, without anatomical alterations in the feet. Seventeen subjects (12%) were lost during the follow-up.


      Prefabricated and customized foot orthoses, both made from EVA, used for 8 weeks.

      Main Outcome Measures

      The primary outcome was pain (modified subscale of the Foot Function Index, [FFI] pain). The secondary outcomes were pain elicited by palpation in the medial calcaneal tuberosity and modified FFI total. Each participant was reviewed in the 4th and 8th weeks of follow-up.


      One hundred twenty-five participants returned to at least 1 of the follow-up evaluations (63 in the prefabricated and 62 in the customized groups). There was a significant improvement in both groups (P<.05), but there was no difference of modified FFI pain between intragroup differences at 4 (4.03 points; 95% confidence interval [CI], −4.2 to 12.3) and 8 weeks (3.93 points; 95% CI, −4.6 to 12.5).


      The low-cost prefabricated and customized foot orthoses, as used in this trial, had similar effectiveness in the treatment of noncomplicated plantar fasciitis after 8 weeks of use. Our results were similar to other trials, although those trials did not use orthoses made from EVA. Thus, EVA prefabricated inserts may be the best choice for the treatment of plantar fasciitis without complication.

      Key Words

      List of Abbreviations:

      CI (confidence interval), EVA (ethylene vinyl acetate), FFI (Foot Function Index)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Archives of Physical Medicine and Rehabilitation
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Buchbinder R.
        Clinical practice.
        N Engl J Med. 2004; 350: 2159-2166
        • Landorf K.B.
        • Keenan A.M.
        • Herbert R.D.
        Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial.
        Arch Intern Med. 2006; 166: 1305-1310
        • Landorf K.B.
        • Keenan A.M.
        • Herbert R.D.
        Effectiveness of different types of foot orthoses for the treatment of plantar fasciitis.
        J Am Podiatr Med Assoc. 2004; 94: 542-549
        • Kogler G.F.
        • Solomonidis S.E.
        • Paul J.P.
        Biomechanics of longitudinal arch support mechanisms in foot orthoses and their effect on plantar aponeurosis strain.
        Clin Biomech. 1996; 11: 243-252
        • Rome K.
        A study of the properties of materials used in podiatry.
        J Am Podiatr Med Assoc. 1991; 81: 73-83
        • Pfeffer G.
        • Bacchetti P.
        • Deland J.
        • et al.
        Comparison of custom and prefabricated orthoses in the initial treatment of proximal plantar fasciitis.
        Foot Ankle Int. 1999; 20: 214-221
        • Roos E.
        • Engström M.
        • Söderberg B.
        Foot orthoses for the treatment of plantar fasciitis.
        Foot Ankle Int. 2006; 27: 606-611
        • Lynch D.M.
        • Goforth W.P.
        • Martin J.E.
        • Odom R.D.
        • Preece C.K.
        • Kotter M.W.
        Conservative treatment of plantar fasciitis.
        J Am Podiatr Med Assoc. 1998; 88: 375-380
        • Martin J.E.
        • Hosch J.C.
        • Goforth W.P.
        • Murff R.T.
        • Lynch D.M.
        • Odom R.D.
        Mechanical treatment of plantar fasciitis.
        J Am Podiatr Med Assoc. 2001; 91: 55-62
        • Turlik M.A.
        • Donatelli T.J.
        • Veremis M.G.
        A comparison of shoe inserts in relieving mechanical heel pain.
        The Foot. 1999; 9: 84-87
        • Crawford F.
        • Thomson C.
        Interventions for treating plantar heel pain.
        Cochrane Database Syst Rev. 2003; 3 (CD000416)
        • Budiman-Mak E.
        • Conrad K.J.
        • Roach K.E.
        The Foot Function Index: a measure of foot pain and disability.
        J Clin Epidemiol. 1991; 44: 561-570
        • Saag K.G.
        • Saltzman C.L.
        • Brown C.K.
        • Budiman-Mak E.
        The Foot Function Index for measuring rheumatoid arthritis pain: evaluating side-to-side reliability.
        Foot Ankle Int. 1996; 17: 506-510
        • Kelly A.M.
        The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain.
        Emerg Med J. 2001; 18: 205-207
        • Todd K.H.
        Clinical versus statistical significance in the assessment of pain relief.
        Ann Emerg Med. 1996; 27: 439-441
        • Kelly A.M.
        Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain?.
        Acad Emerg Med. 1998; 5: 1086-1090
        • Vickers A.J.
        • Altman D.G.
        Statistics notes: analysing controlled trials with baseline and follow up measurements.
        BMJ. 2001; 323: 1123-1124
        • Dyck Jr, D.D.
        • Boyajian-O'Neill L.A.
        Plantar fasciitis.
        Clin J Sport Med. 2004; 14: 305-309
        • Gill L.H.
        • Kiebzak G.M.
        Outcome of nonsurgical treatment for plantar fasciitis [published erratum appears in Foot Ankle 1996;17:722].
        Foot Ankle Int. 1996; 17: 527-532
        • Raab G.M.
        • Day S.
        • Sales J.
        How to select covariates to include in the analysis of a clinical trial.
        Control Clin Trials. 2000; 21: 330-342
        • Twisk J.
        • Proper K.
        Evaluation of the results of a randomized controlled trial: how to define changes between baseline and follow-up.
        J Clin Epidemiol. 2004; 57: 223-228
        • Becker H.
        • Roberts G.
        • Voelmeck W.
        Explanations for improvement in both experimental and control groups.
        West J Nurs Res. 2003; 25: 746-755
        • Gotzsche P.C.
        Lessons from and cautions about noninferiority and equivalence randomized trials.
        JAMA. 2006; 295: 1172-1174
        • Maher C.G.
        • Sherrington C.
        • Herbert R.D.
        • Moseley A.M.
        • Elkins M.
        Reliability of the PEDro scale for rating quality of randomized controlled trials.
        Phys Ther. 2003; 83: 713-721