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Published in: BMC Musculoskeletal Disorders 1/2018

Open Access 01-12-2018 | Research article

Custom foot orthoses improve first-step pain in individuals with unilateral plantar fasciopathy: a pragmatic randomised controlled trial

Authors: Chris Bishop, Dominic Thewlis, Susan Hillier

Published in: BMC Musculoskeletal Disorders | Issue 1/2018

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Abstract

Background

Foot orthoses are routinely used to treat plantar fasciopathy in clinical practice. However, minimal evidence exists as to the effect of both truly custom designed foot orthoses, as well as that of the shoe the foot orthoses are placed into. This study investigated the effect of wearing custom foot orthoses and new athletic footwear on first-step pain, average 24-h pain and plantar fascia thickness in people with unilateral plantar fasciopathy over 12 weeks.

Methods

A parallel, three-arm randomised controlled trial with blinding of participants and assessors. 60 participants diagnosed with unilateral plantar fasciopathy were randomised to either custom foot orthoses and new shoes (orthoses group), a sham insole with a new shoes (shoe group) or a sham insole placed in the participant’s regular shoes (control group). Primary outcome was first-step pain. Secondary outcomes were average 24-h pain and plantar fascia thickness measured on ultrasound. Outcomes were assessed at baseline, 4 week and 12 week trial time-points.

Results

At 4 weeks, the orthoses group reported less first-step pain (p = 0.002) compared to the control group. At 12 weeks, the orthoses group reported less first-step pain compared to both the shoe (p = < 0.001) and sham (p = 0.01) groups. Both the orthoses (p = < 0.001) and shoe (p = 0.006) groups reported less average 24-h pain compared to the control group at 4 and 12 weeks. The orthoses group demonstrated reduced plantar fascia thickness on ultrasound compared to both the shoe (p = 0.032) and control groups (p = 0.011).

Conclusions

Custom foot orthoses in new shoes improve first-step pain and reduce plantar fascia thickness over a period of 12 weeks compared to new shoes alone or a sham intervention.

Trial registration

Australian New Zealand Clinical Trials Registry (ACTRN 12613000446763). Submitted on the 10th of April 2013 and registered on the 18th of April 2013.
Appendix
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Literature
1.
go back to reference Crawford F, Atkins D, Edwards J. Interventions for treating plantar heel pain. Foot. 2001;11(4):228–50.CrossRef Crawford F, Atkins D, Edwards J. Interventions for treating plantar heel pain. Foot. 2001;11(4):228–50.CrossRef
2.
go back to reference Tong KB, Furia J. Economic burden of plantar fasciitis treatment in the United States. Am J Orthop (Belle Mead NJ). 2010;39(5):227–31. Tong KB, Furia J. Economic burden of plantar fasciitis treatment in the United States. Am J Orthop (Belle Mead NJ). 2010;39(5):227–31.
3.
go back to reference Landorf KB: Plantar heel pain and plantar fasciitis. Systematic review 1111. BMJ Clin Evid. 2015;2015. Landorf KB: Plantar heel pain and plantar fasciitis. Systematic review 1111. BMJ Clin Evid. 2015;2015.
4.
go back to reference Riddle DL, Pulisic M, Sparrow K. Impact of demographic and impairment-related variables on disability associated with plantar fasciitis. Foot Ankle Int. 2004;25(5):311–7.CrossRefPubMed Riddle DL, Pulisic M, Sparrow K. Impact of demographic and impairment-related variables on disability associated with plantar fasciitis. Foot Ankle Int. 2004;25(5):311–7.CrossRefPubMed
5.
go back to reference Irving DB, Cook JL, Young MA, Menz HB. Impact of chronic plantar heel pain on health-related quality of life. J Am Podiatr Med Assoc. 2008;98(4):283–9.CrossRefPubMed Irving DB, Cook JL, Young MA, Menz HB. Impact of chronic plantar heel pain on health-related quality of life. J Am Podiatr Med Assoc. 2008;98(4):283–9.CrossRefPubMed
6.
go back to reference Chang R, Rodrigues PA, Van Emmerik REA, Hamill J. Multi-segment foot kinematics and ground reaction forces during gait of individuals with plantar fasciitis. J Biomech. 2014;47(11):2571–7.CrossRefPubMed Chang R, Rodrigues PA, Van Emmerik REA, Hamill J. Multi-segment foot kinematics and ground reaction forces during gait of individuals with plantar fasciitis. J Biomech. 2014;47(11):2571–7.CrossRefPubMed
7.
go back to reference Sullivan J, Burns J, Adams R, Pappas E, Crosbie J. Plantar heel pain and foot loading during normal walking. Gait & posture. 2015;41(2):688–93.CrossRef Sullivan J, Burns J, Adams R, Pappas E, Crosbie J. Plantar heel pain and foot loading during normal walking. Gait & posture. 2015;41(2):688–93.CrossRef
8.
go back to reference Wearing SC, Smeathers JE, Urry SR. The effect of plantar fasciitis on vertical foot-ground reaction force. Clin Orthop Relat Res. 2003;409:175–85.CrossRef Wearing SC, Smeathers JE, Urry SR. The effect of plantar fasciitis on vertical foot-ground reaction force. Clin Orthop Relat Res. 2003;409:175–85.CrossRef
9.
go back to reference Landorf KB, Keenan A, Herbert RD. Effectiveness of foot orthoses to treat plantar fasciiti: s a randomized trial. Arch Intern Med. 2006;166(12):1305–10.CrossRefPubMed Landorf KB, Keenan A, Herbert RD. Effectiveness of foot orthoses to treat plantar fasciiti: s a randomized trial. Arch Intern Med. 2006;166(12):1305–10.CrossRefPubMed
10.
go back to reference Pfeffer G, Bacchetti P, Deland J, Lewis A, Anderson R, Davis W, Alvarez R, Brodsky J, Cooper P, Frey C. Comparison of custom and prefabricated orthoses in the initial treatment of proximal plantar fasciitis. Foot & Ankle International. 1999;20(4):214–21.CrossRef Pfeffer G, Bacchetti P, Deland J, Lewis A, Anderson R, Davis W, Alvarez R, Brodsky J, Cooper P, Frey C. Comparison of custom and prefabricated orthoses in the initial treatment of proximal plantar fasciitis. Foot & Ankle International. 1999;20(4):214–21.CrossRef
11.
go back to reference Martin JE, Hosch JC, Preston Goforth W, Murff RT, Matt Lynch D, Odom RD. Mechanical treatment of plantar fasciitis: a prospective study. J Am Podiatr Med Assoc. 2001;91(2):55–62.CrossRefPubMed Martin JE, Hosch JC, Preston Goforth W, Murff RT, Matt Lynch D, Odom RD. Mechanical treatment of plantar fasciitis: a prospective study. J Am Podiatr Med Assoc. 2001;91(2):55–62.CrossRefPubMed
12.
go back to reference 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. Arch Phys Med Rehabil. 2009;90(4):701–6.CrossRefPubMed 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. Arch Phys Med Rehabil. 2009;90(4):701–6.CrossRefPubMed
13.
go back to reference Roos E, Engström M, Söderberg B. Foot orthoses for the treatment of plantar fasciitis. Foot & ankle international. 2006;27(8):606–11.CrossRef Roos E, Engström M, Söderberg B. Foot orthoses for the treatment of plantar fasciitis. Foot & ankle international. 2006;27(8):606–11.CrossRef
14.
go back to reference Lynch DM, Goforth W, Martin J, Odom R, Preece C, Kotter M. Conservative treatment of plantar fasciitis. A prospective study. J Am Podiatr Med Assoc. 1998;88(8):375–80.CrossRefPubMed Lynch DM, Goforth W, Martin J, Odom R, Preece C, Kotter M. Conservative treatment of plantar fasciitis. A prospective study. J Am Podiatr Med Assoc. 1998;88(8):375–80.CrossRefPubMed
15.
go back to reference Whittaker GA, Munteanu SE, Menz HB, Tan JM, Rabusin CL, Landorf KB. Foot orthoses for plantar heel pain: a systematic review and meta-analysis. Br J Sports Med. 2018;52(5):322–8.CrossRefPubMed Whittaker GA, Munteanu SE, Menz HB, Tan JM, Rabusin CL, Landorf KB. Foot orthoses for plantar heel pain: a systematic review and meta-analysis. Br J Sports Med. 2018;52(5):322–8.CrossRefPubMed
16.
go back to reference Rasenberg N, Riel H, Rathleff MS, Bierma-Zeinstra SM, van Middelkoop M. Efficacy of foot orthoses for the treatment of plantar heel pain: a systematic review and meta-analysis. Br J Sports Med. 2018:bjsports-2017-097892. Rasenberg N, Riel H, Rathleff MS, Bierma-Zeinstra SM, van Middelkoop M. Efficacy of foot orthoses for the treatment of plantar heel pain: a systematic review and meta-analysis. Br J Sports Med. 2018:bjsports-2017-097892.
17.
go back to reference Whittaker GA, Munteanu SE, Menz HB, Landorf KB. Should foot orthoses be used for plantar heel pain? Br J Sports Med. 2018; Whittaker GA, Munteanu SE, Menz HB, Landorf KB. Should foot orthoses be used for plantar heel pain? Br J Sports Med. 2018;
18.
go back to reference Landorf K, Keenan A-M, Rushworth RL. Foot orthosis prescription habits of Australian and New Zealand podiatric physicians. J Am Podiatr Med Assoc. 2001;91(4):174–83.CrossRefPubMed Landorf K, Keenan A-M, Rushworth RL. Foot orthosis prescription habits of Australian and New Zealand podiatric physicians. J Am Podiatr Med Assoc. 2001;91(4):174–83.CrossRefPubMed
19.
go back to reference Menz HB, Allan JJ, Bonanno DR, Landorf KB, Murley GS. Custom-made foot orthoses: an analysis of prescription characteristics from an Australian commercial orthotic laboratory. J Foot Ankle Res. 2017;10(1):23.CrossRefPubMedPubMedCentral Menz HB, Allan JJ, Bonanno DR, Landorf KB, Murley GS. Custom-made foot orthoses: an analysis of prescription characteristics from an Australian commercial orthotic laboratory. J Foot Ankle Res. 2017;10(1):23.CrossRefPubMedPubMedCentral
20.
go back to reference Banwell HA, Mackintosh S, Thewlis D, Landorf KB. Consensus-based recommendations of Australian podiatrists for the prescription of foot orthoses for symptomatic flexible pes planus in adults. J Foot Ankle Res. 2014;7(1):1–13.CrossRef Banwell HA, Mackintosh S, Thewlis D, Landorf KB. Consensus-based recommendations of Australian podiatrists for the prescription of foot orthoses for symptomatic flexible pes planus in adults. J Foot Ankle Res. 2014;7(1):1–13.CrossRef
21.
go back to reference Redmond A, Lumb PSB, Landorf K. Effect of cast and noncast foot orthoses on plantar pressure and force during normal gait. J Am Podiatr Med Assoc. 2000;90(9):441–9.CrossRefPubMed Redmond A, Lumb PSB, Landorf K. Effect of cast and noncast foot orthoses on plantar pressure and force during normal gait. J Am Podiatr Med Assoc. 2000;90(9):441–9.CrossRefPubMed
22.
go back to reference Kirby KA. The medial heel skive technique. Improving pronation control in foot orthoses. J Am Podiatr Med Assoc. 1992;82(4):177–88.CrossRefPubMed Kirby KA. The medial heel skive technique. Improving pronation control in foot orthoses. J Am Podiatr Med Assoc. 1992;82(4):177–88.CrossRefPubMed
23.
go back to reference Sloss R. The effects of foot orthoses on the ground reaction forces during walking. Part 1. Foot. 2001;11(4):205–14.CrossRef Sloss R. The effects of foot orthoses on the ground reaction forces during walking. Part 1. Foot. 2001;11(4):205–14.CrossRef
24.
go back to reference Mills K, Blanch P, Chapman AR, McPoil TG, Vicenzino B. Foot orthoses and gait: a systematic review and meta-analysis of literature pertaining to potential mechanisms. Br J Sports Med. 2010;44(14):1035–46.CrossRefPubMed Mills K, Blanch P, Chapman AR, McPoil TG, Vicenzino B. Foot orthoses and gait: a systematic review and meta-analysis of literature pertaining to potential mechanisms. Br J Sports Med. 2010;44(14):1035–46.CrossRefPubMed
25.
go back to reference Arnold JB, Bishop C. Quantifying foot kinematics inside athletic footwear: a review. Footwear Science. 2013;5(1):55–62.CrossRef Arnold JB, Bishop C. Quantifying foot kinematics inside athletic footwear: a review. Footwear Science. 2013;5(1):55–62.CrossRef
26.
go back to reference Riel H, Cotchett M, Delahunt E, Rathleff MS, Vicenzino B, Weir A, Landorf KB. Is ‘plantar heel pain’a more appropriate term than ‘plantar fasciitis’? Time to move on. In: BMJ Publishing Group Ltd and British Association of Sport and Exercise Medicine; 2017. Riel H, Cotchett M, Delahunt E, Rathleff MS, Vicenzino B, Weir A, Landorf KB. Is ‘plantar heel pain’a more appropriate term than ‘plantar fasciitis’? Time to move on. In: BMJ Publishing Group Ltd and British Association of Sport and Exercise Medicine; 2017.
27.
go back to reference Alshami AM, Souvlis T, Coppieters MW. A review of plantar heel pain of neural origin: differential diagnosis and management. Man Ther. 2008;13(2):103–11.CrossRefPubMed Alshami AM, Souvlis T, Coppieters MW. A review of plantar heel pain of neural origin: differential diagnosis and management. Man Ther. 2008;13(2):103–11.CrossRefPubMed
28.
go back to reference McPoil TG, Martin RL, Cornwall MW, Wukich DK, Irrgang JJ, Godges JJ. Heel pain - plantar fasciitis: Clinical practice guidelines linked to the international classification of function, disability, and health from the Orthopaedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008;38(4):A1–A18.CrossRefPubMed McPoil TG, Martin RL, Cornwall MW, Wukich DK, Irrgang JJ, Godges JJ. Heel pain - plantar fasciitis: Clinical practice guidelines linked to the international classification of function, disability, and health from the Orthopaedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008;38(4):A1–A18.CrossRefPubMed
29.
go back to reference Thomas JL, Christensen JC, Kravitz SR, Mendicino RW, Schuberth JM, Vanore JV, Weil LS, Zlotoff HJ, Bouché R, Baker J. The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. J Foot Ankle Surg. 2010;49(3):S1–S19.CrossRefPubMed Thomas JL, Christensen JC, Kravitz SR, Mendicino RW, Schuberth JM, Vanore JV, Weil LS, Zlotoff HJ, Bouché R, Baker J. The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. J Foot Ankle Surg. 2010;49(3):S1–S19.CrossRefPubMed
30.
go back to reference McPoil TG, Hunt GC. Evaluation and management of foot and ankle disorders: present problems and future directions. J Orthop Sports Phys Ther. 1995;21(6):381–8.CrossRefPubMed McPoil TG, Hunt GC. Evaluation and management of foot and ankle disorders: present problems and future directions. J Orthop Sports Phys Ther. 1995;21(6):381–8.CrossRefPubMed
31.
go back to reference Lee SY, McKeon P, Hertel J. Does the use of orthoses improve self-reported pain and function measures in patients with plantar fasciitis? A meta-analysis. Physical Therapy in Sport. 2009;10(1):12–8.CrossRefPubMed Lee SY, McKeon P, Hertel J. Does the use of orthoses improve self-reported pain and function measures in patients with plantar fasciitis? A meta-analysis. Physical Therapy in Sport. 2009;10(1):12–8.CrossRefPubMed
32.
go back to reference World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects [www.wma.net]. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects [www.​wma.​net].
33.
34.
go back to reference Landorf KB, Radford JA, Hudson S: Minimal important difference (MID) of two commonly used outcome measures for foot problems. J Foot Ankle Res 2010, 3(1). Landorf KB, Radford JA, Hudson S: Minimal important difference (MID) of two commonly used outcome measures for foot problems. J Foot Ankle Res 2010, 3(1).
35.
go back to reference McNally EG, Shetty S. Plantar fascia: imaging diagnosis and guided treatment. In: Seminars in Musculoskeletal Radiology, vol. 2010; 2010. p. 334. McNally EG, Shetty S. Plantar fascia: imaging diagnosis and guided treatment. In: Seminars in Musculoskeletal Radiology, vol. 2010; 2010. p. 334.
36.
go back to reference Wall JR, Harkness MA, Crawford A. Ultrasound diagnosis of plantar fasciitis. Foot and Ankle. 1993;14(8):465–70.CrossRefPubMed Wall JR, Harkness MA, Crawford A. Ultrasound diagnosis of plantar fasciitis. Foot and Ankle. 1993;14(8):465–70.CrossRefPubMed
37.
go back to reference McMillan AM, Landorf KB, Barrett JT, Menz HB, Bird AR. Diagnostic imaging for chronic plantar heel pain: a systematic review and meta-analysis. J Foot Ankle Res. 2009;2:32.CrossRefPubMedPubMedCentral McMillan AM, Landorf KB, Barrett JT, Menz HB, Bird AR. Diagnostic imaging for chronic plantar heel pain: a systematic review and meta-analysis. J Foot Ankle Res. 2009;2:32.CrossRefPubMedPubMedCentral
38.
go back to reference Schepsis AA, Leach RE, Gorzyca J. Plantar fasciitis: etiology, treatment, surgical results, and review of the literature. Clin Orthop Relat Res. 1991;266:185–96. Schepsis AA, Leach RE, Gorzyca J. Plantar fasciitis: etiology, treatment, surgical results, and review of the literature. Clin Orthop Relat Res. 1991;266:185–96.
39.
go back to reference Moore R, Edwards J, McQuay H. Acute pain: individual patient meta-analysis shows the impact of different ways of analysing and presenting results. Pain. 2005;116(3):322–31.CrossRefPubMed Moore R, Edwards J, McQuay H. Acute pain: individual patient meta-analysis shows the impact of different ways of analysing and presenting results. Pain. 2005;116(3):322–31.CrossRefPubMed
40.
go back to reference McMillan AM, Landorf KB, Gilheany MF, Bird AR, Morrow AD, Menz HB: Ultrasound guided corticosteroid injection for plantar fasciitis: randomised controlled trial. BMJ (Online) 2012, 344 (7859). McMillan AM, Landorf KB, Gilheany MF, Bird AR, Morrow AD, Menz HB: Ultrasound guided corticosteroid injection for plantar fasciitis: randomised controlled trial. BMJ (Online) 2012, 344 (7859).
42.
go back to reference Cook JL, Purdam CR. Is tendon pathology a continuum? A pathology model to explain the clinical presentation of load-induced tendinopathy. Br J Sports Med. 2009;43(6):409–16.CrossRefPubMed Cook JL, Purdam CR. Is tendon pathology a continuum? A pathology model to explain the clinical presentation of load-induced tendinopathy. Br J Sports Med. 2009;43(6):409–16.CrossRefPubMed
43.
go back to reference Nigg BM, Herzog W: Biomechanics of the musculo-skeletal system. England: Wiley; 2007. Nigg BM, Herzog W: Biomechanics of the musculo-skeletal system. England: Wiley; 2007.
44.
go back to reference Lewinson RT, Stefanyshyn DJ. Losing control over control conditions in knee osteoarthritis orthotic research. Contemporary clinical trials. 2015;42:258–9.CrossRefPubMed Lewinson RT, Stefanyshyn DJ. Losing control over control conditions in knee osteoarthritis orthotic research. Contemporary clinical trials. 2015;42:258–9.CrossRefPubMed
45.
go back to reference Bonanno DR, Landorf KB, Murley GS, Menz HB. Selecting control interventions for use in orthotic trials: the methodological benefits of sham orthoses. Contemp Clin Trials. 2015;42:257.CrossRefPubMed Bonanno DR, Landorf KB, Murley GS, Menz HB. Selecting control interventions for use in orthotic trials: the methodological benefits of sham orthoses. Contemp Clin Trials. 2015;42:257.CrossRefPubMed
46.
go back to reference Lewinson RT, Worobets JT, Stefanyshyn DJ. Control conditions for footwear insole and orthotic research. Gait & posture. 2016;48:99–105.CrossRef Lewinson RT, Worobets JT, Stefanyshyn DJ. Control conditions for footwear insole and orthotic research. Gait & posture. 2016;48:99–105.CrossRef
47.
Metadata
Title
Custom foot orthoses improve first-step pain in individuals with unilateral plantar fasciopathy: a pragmatic randomised controlled trial
Authors
Chris Bishop
Dominic Thewlis
Susan Hillier
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2018
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-018-2131-6

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