Effectiveness of Mechanical Treatment with Customized Insole and Minimalist Flexible Footwear for Women with Calcaneal Spur: Randomized Controlled Trial

Overview

Journal BMC Musculoskelet Disord

Publisher Biomed Central

Specialties Orthopedics
Physiology

Date 2022 Aug 13

PMID 35964021

Authors

Ana Paula Ribeiro

Brenda Luciano de Souza

Silvia Maria Amado Joao

Affiliations

Soon will be listed here.

Abstract

Backround: Calcaneal spurs are described as bony outgrowths arising on medial calcaneal, where inappropriate footwear can promote disease progression.

Objective: Investigate the effectiveness of mechanical treatment with customized insole and minimalist flexible footwear during gait training program in women with calcaneal spur.

Methods: Design: A single-blinded, randomized and controlled trial.

Setting: Biomechanics laboratory.

Participants: Forty-three women, 29 with calcaneal spur and 14 control.

Intervention: Gait training program with use of the minimalist flexible footwear (MFG n = 15, age: 48.9 ± 9.4, height: 1.61 ± 0.1, BMI: 32.1 ± 7.0) and customized insole on footwear (COIG n = 14, age: 50.3 ± 5.8, height: 1.62 ± 0.1, BMI: 32.2 ± 4.3) and control (CG n = 14, age: 47.8 ± 8.6, height: 1.63 ± 0.1, BMI: 27.5 ± 4.5), followed of the evaluations: baseline (T0) and after three (T3) and six (T6) months. Duration of the intervention was of the six months consecutive for at least 42 h per week (six hours a day, seven days a week). Outcome primary were calcaneus pain (visual analogue scale), Foot Function Index (FFI), Foot Health Status Questionnaire (FHSQ-Br) and 6-min walk test (6MWT). Secondary was plantar pressure distribution by a pressure platform system during gait and static index foot posture (FPI).

Statistical Analysis: analysis of variance for repeated measure and between groups were used to detect treatment-time interactions (α = 5%). Effect size with D Cohen's also was used between T0 and after six (T6) months of intervention.

Results: The MFG and COIG were effective at reducing pain after six months (MFG: 2.5-4.5 CI, p = 0.001; COIG: 1.5-3.5 CI, p = 0.011). The FFI and FHSQ-Br showed improvements with MFG and COIG after T6 (MFG: 13.7-15.4 CI, p = 0.010; COIG: 11.3-15.0 CI, p = 0.001). The 6MWT increased with MFG (589.3-622.7 CI) and COIG (401.3-644.7 CI) and foot pronation was decreased after T3 and T6 MFG (FPI Right: 4.2-5.4 CI; Left: 3.6-5.4 CI) COIG (FPI Right: 3.4-6.8 CI; Left: 3.3-5.7 CI). The contact area reduced on forefoot and rearfoot with MFG and GOIG and midfoot and rearfoot with MFG. Maximum force was reduced on foot with MFG after T3 and T6. The peak pressure was reduced on the forefoot with MFG and COIG and on midfoot and rearfoot with MFG.

Conclusions: The mechanical treatment with customized insole and minimalist flexible footwear during gait training program during six months in women with calcaneal spur reduced the calcaneus pain, increased function and health feet and reduced plantar load on the rearfoot, midfoot and forefoot. However, the footwear alone was more effective than when combined customized insole, given the greater efficacy on clinical and biomechanical aspects.

Trial Registration: ClinicalTrials.gov NCT03040557 (date of first registration: 02/02/2017).

Citing Articles

The Effect of Short and Long-Term Therapeutic Treatment with Insoles and Shoes on Pain, Function, and Plantar Load Parameters of Women with Plantar Fasciitis: A Randomized Controlled Trial.

Ribeiro A, Maria Amado Joao S Medicina (Kaunas). 2022; 58(11).

PMID: 36363506 PMC: 9695781. DOI: 10.3390/medicina58111546.

References

Thomas J, Christensen J, Kravitz S, Mendicino R, Schuberth J, Vanore J . The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. J Foot Ankle Surg. 2010; 49(3 Suppl):S1-19. DOI: 10.1053/j.jfas.2010.01.001. View

Shakoor N, Lidtke R, Wimmer M, Mikolaitis R, Foucher K, Thorp L . Improvement in knee loading after use of specialized footwear for knee osteoarthritis: results of a six-month pilot investigation. Arthritis Rheum. 2013; 65(5):1282-9. DOI: 10.1002/art.37896. View

Irving D, Cook J, Young M, Menz H . Obesity and pronated foot type may increase the risk of chronic plantar heel pain: a matched case-control study. BMC Musculoskelet Disord. 2007; 8:41. PMC: 1884155. DOI: 10.1186/1471-2474-8-41. View

Rasenberg N, Bierma-Zeinstra S, Fuit L, Rathleff M, Dieker A, van Veldhoven P . Custom insoles versus sham and GP-led usual care in patients with plantar heel pain: results of the STAP-study - a randomised controlled trial. Br J Sports Med. 2020; 55(5):272-278. PMC: 7907578. DOI: 10.1136/bjsports-2019-101409. View

Hong W, Lee Y, Chen H, Pei Y, Wu C . Influence of heel height and shoe insert on comfort perception and biomechanical performance of young female adults during walking. Foot Ankle Int. 2006; 26(12):1042-8. DOI: 10.1177/107110070502601208. View

McMillan A, Landorf K, Barrett J, Menz H, Bird A . Diagnostic imaging for chronic plantar heel pain: a systematic review and meta-analysis. J Foot Ankle Res. 2009; 2:32. PMC: 2784446. DOI: 10.1186/1757-1146-2-32. View

Tong K, Furia J . Economic burden of plantar fasciitis treatment in the United States. Am J Orthop (Belle Mead NJ). 2010; 39(5):227-31. View

Redmond A, Crane Y, Menz H . Normative values for the Foot Posture Index. J Foot Ankle Res. 2008; 1(1):6. PMC: 2553778. DOI: 10.1186/1757-1146-1-6. View

Cronin N, Barrett R, Carty C . Long-term use of high-heeled shoes alters the neuromechanics of human walking. J Appl Physiol (1985). 2012; 112(6):1054-8. DOI: 10.1152/japplphysiol.01402.2011. View

10.

Lemont H, Ammirati K, Usen N . Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003; 93(3):234-7. DOI: 10.7547/87507315-93-3-234. View

11.

Cohena-Jimenez M, Pabon-Carrasco M, Perez Belloso A . Comparison between customised foot orthoses and insole combined with the use of extracorporeal shock wave therapy in plantar fasciitis, medium-term follow-up results: A randomised controlled trial. Clin Rehabil. 2020; 35(5):740-749. DOI: 10.1177/0269215520976619. View

12.

Kuyucu E, Kocyigit F, Erdil M . The association of calcaneal spur length and clinical and functional parameters in plantar fasciitis. Int J Surg. 2015; 21:28-31. DOI: 10.1016/j.ijsu.2015.06.078. View

13.

Fong D, Pang K, Chung M, Hung A, Chan K . Evaluation of combined prescription of rocker sole shoes and custom-made foot orthoses for the treatment of plantar fasciitis. Clin Biomech (Bristol). 2012; 27(10):1072-7. DOI: 10.1016/j.clinbiomech.2012.08.003. View

14.

Shakoor N, Lidtke R, Sengupta M, Fogg L, Block J . Effects of specialized footwear on joint loads in osteoarthritis of the knee. Arthritis Rheum. 2008; 59(9):1214-20. PMC: 3653288. DOI: 10.1002/art.24017. View

15.

Trombini-Souza F, Matias A, Yokota M, Butugan M, Goldenstein-Schainberg C, Fuller R . Long-term use of minimal footwear on pain, self-reported function, analgesic intake, and joint loading in elderly women with knee osteoarthritis: A randomized controlled trial. Clin Biomech (Bristol). 2015; 30(10):1194-201. DOI: 10.1016/j.clinbiomech.2015.08.004. View

16.

Ribeiro A, Maria Amado Joao S, Dinato R, Tessutti V, Sacco I . Dynamic Patterns of Forces and Loading Rate in Runners with Unilateral Plantar Fasciitis: A Cross-Sectional Study. PLoS One. 2015; 10(9):e0136971. PMC: 4574154. DOI: 10.1371/journal.pone.0136971. View

17.

Toumi H, Davies R, Mazor M, Coursier R, Best T, Jennane R . Changes in prevalence of calcaneal spurs in men & women: a random population from a trauma clinic. BMC Musculoskelet Disord. 2014; 15:87. PMC: 3995580. DOI: 10.1186/1471-2474-15-87. View

18.

Ribeiro A, Trombini-Souza F, Tessutti V, Rodrigues Lima F, de Camargo Neves Sacco I, Maria Amado Joao S . Rearfoot alignment and medial longitudinal arch configurations of runners with symptoms and histories of plantar fasciitis. Clinics (Sao Paulo). 2011; 66(6):1027-33. PMC: 3129964. DOI: 10.1590/s1807-59322011000600018. View

19.

Kirkpatrick J, Yassaie O, Mirjalili S . The plantar calcaneal spur: a review of anatomy, histology, etiology and key associations. J Anat. 2017; 230(6):743-751. PMC: 5442149. DOI: 10.1111/joa.12607. View

20.

Ceran Serdar C, Cihan M, Yucel D, Serdar M . Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies. Biochem Med (Zagreb). 2020; 31(1):010502. PMC: 7745163. DOI: 10.11613/BM.2021.010502. View