• 1

    du Toit V, Smith R: Survey of the effects of aerobic dance on the lower extremity in aerobic instructors. .JAPMA 91::528. ,2001. .

  • 2

    van Mechelen W: Running injuries: a review of the epidemiological literature. .Sports Med 14::320. ,1992. .

  • 3

    Landorf KB, Keenan AM: Efficacy of foot orthoses: what does the literature tell us?. JAPMA 90::149. ,2000. .

  • 4

    Walter JH Jr, Ng G, Stoltz JJ: A patient satisfaction survey on prescription custom-molded foot orthoses. .JAPMA 94::363. ,2004. .

  • 5

    Vicenzino B: Foot orthotics in the treatment of lower limb conditions: a musculoskeletal physiotherapy perspective. .Man Ther 9::185. ,2004. .

  • 6

    Pratt DJ: A critical review of the literature on foot orthoses. .JAPMA 90::339. ,2000. .

  • 7

    Rome K, Gray J, Stewart F, et al: Evaluating the clinical effectiveness and cost-effectiveness of foot orthoses in the treatment of plantar heel pain: a feasibility study. .JAPMA 94::229. ,2004. .

    • Search Google Scholar
    • Export Citation
  • 8

    Martin JE, Hosch JC, Goforth WP, et al: Mechanical treatment of plantar fasciitis: a prospective study. .JAPMA 91::55. ,2001. .

  • 9

    Roos E, Engstrom M, Soderberg B: Foot orthoses for the treatment of plantar fasciitis. .Foot Ankle Int 27::606. ,2006. .

  • 10

    Spadoni G, Stratford PW, Solomon PE, et al: The evaluation of change in pain intensity: a comparison of P4 and single-item numeric pain rating scales. .J Orthop Sports Phys Ther 34::187. ,2004. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 11

    Williamson A, Hoggart B: Pain: a review of three commonly used pain rating scales. .J Clin Nurs 14::798. ,2005. .

  • 12

    Farrar JT, Berlin JA, Strom BL: Clinically important changes in acute pain outcome measures: a validation study. .J Pain Symptom Manage 25::406. ,2003. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 13

    Stratford PW, Spadoni GF: The reliability, consistency and clinical application of a numeric pain rating scale. .Physiother Can 53::88. ,2001. .

    • Search Google Scholar
    • Export Citation
  • 14

    Salaffi F, Stancati A, Silvestri CA, et al: Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. .Eur J Pain 8::283. ,2004. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 15

    Trotter LC, Pierrynowski MR: Ability of foot care professionals to cast feet using the nonweightbearing plaster and the gait-referenced foam casting techniques. .JAPMA 98::14. ,2008. .

    • Search Google Scholar
    • Export Citation
  • 16

    Porthouse J, Torgerson DJ: The need for randomized controlled trials in podiatric medical research. .JAPMA 94::221. ,2004. .

  • 17

    Sackett D: Rules of evidence and clinical recommendations on the use of antithrombotic agents. .Chest 89::2S. ,1986. .

  • 18

    Kilmartin TE, Barrington RL, Wallace WA: A controlled prospective trial of a foot orthosis for juvenile hallux valgus. .J Bone Joint Surg Br 76::210. ,1994. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 19

    Mayo E: The Human Problems of an Industrial Civilization, MacMillan, New York. ,1933. .

  • 20

    Lynch DM, Goforth WP, Martin JE, et al: Conservative treatment of plantar fasciitis: a prospective study. .JAPMA 88::375. ,1998. .

  • 21

    DeMarchi A, Robba T, Ferrarese E, et al: Imaging in musculoskeletal injuries: state of the art. .Radiol Med 110::115. ,2005. .

The Short-term Effectiveness of Full-Contact Custom-made Foot Orthoses and Prefabricated Shoe Inserts on Lower-Extremity Musculoskeletal Pain

A Randomized Clinical Trial

Leslie C. Trotter DC, MBA, MSc, CPed(C)1 and Michael Raymond Pierrynowski PhD2
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  • 1 Foot-Knee-Back Clinic, Ancaster, Ontario, Canada.
  • | 2 School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.
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Background: Foot orthoses are commonly dispensed for musculoskeletal complaints of the foot and lower limb. Few randomized clinical trials evaluate the clinical effectiveness of foot orthoses.

Methods: In this randomized clinical trial with a crossover design, 42 participants wore custom orthoses and prefabricated inserts in their regular footwear for 4 weeks each, consecutively. Twenty-seven participants received prefabricated inserts first and 13 received custom orthoses first. A numeric pain rating scale (possible score, 0–10) was used to measure participant pain.

Results: Statistically and clinically important decreases in pain were reported after 3 weeks by participants wearing custom orthoses first (−1.39 pain units, t12 = 2.70, P = .02). Participants who wore prefabricated inserts first reported no statistically significant change in pain. When the alternative intervention was introduced, participants now wearing prefabricated inserts had greater pain after 1 and 2 weeks (1.1 pain units, t12 = 3.09, P = .01 and 0.9 pain units, t12 = 2.65, P = .02, respectively). Participants now wearing custom orthoses did not demonstrate significantly lower pain at any week compared with the second baseline but did have significantly lower pain scores compared with their initial baseline scores (−0.81 pain units, t12 = 2.31, P = .03).

Conclusion: Full-contact custom-made foot orthoses provide symptomatic relief after 3 weeks of use for patients with lower-extremity musculoskeletal pain if they are prescribed as the initial treatment. (J Am Podiatr Med Assoc 98(5): 357–363, 2008)

Corresponding author: Leslie C. Trotter, DC, MBA, MSc, CPed (C), Foot-Knee-Back Clinic, 3 Wilson St E, Ancaster, ON L9G 2B3, Canada. (E-mail: leslietrotter@cogeco.ca)