NCT04461197

Efficacy of the Treatment of Plantar Orthoses With Extracorporeal Shock Wave Therapy in Plantar Fasciitis

Efficacy of the Therapeutic Effects of Adjunctive Treatment of Plantar Orthoses With Extracorporeal Shock Wave Therapy in Plantar Fasciitis: a Randomized Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: University of Seville · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Plantar fasciitis is inflammation of plantar fascia. It arises from degeneration and chronic inflammation. Treatment of plantar fasciitis contains conservative methods like rest, body weight control, stretching exercise, non-steroidal anti-inflammatory drugs and arch supports. ESWT has commonly been used for the treatment of plantar fasciitis. The shock waves can be radial or focused. The aim of this study was to evaluate the effectiveness of the adjuvant use of plantar orthoses in the process of plantar fasciitis when extracorporeal shock waves are applied. The hypothesis porposed was that the use of extracorporeal shock waves together with the use of custom foot orthotics improves the symptoms produced by plantar fasciitis. This study is planned as double-blind, randomized controlled trial. Participants are randomly allocated to two groups: the ESWT group and the custom foot orthotics and ESWT group. Radial ESWT will be applied in this study. The people receiving the therapy and the people assessing the outcomes are blinded . Both group will recieve ESWT one session per week for three weeks. Each session will last for 2-5 minutes. The primary outcome measure of this study is change in heel pain of affected side assessed using Visual Analog Scale. The secondary outcome measure is Roles y Maudsley scores. The primary endpoint of this study is to determine a decrease in pain score according to Visual Analog Scale.

Conditions

• Fasciitis, Plantar, Chronic

Interventions

Type	Name	Description
DEVICE	customised foot orthoses	The foot orthoses for group A were custom made using phenolic foam molds of the feet. Separated molds were made of both feet for all the participants. . The insole was made based on a positive mold of plaster with 45 Shore cork materials with horizontal thrusts just proximal to the metatarsal heads, with the intention of correcting the pathological subtalar pronation, with a 3mm bilateral raising of the heel and a bilateral latex metatarsal bar.
DEVICE	orthotic insole	For group B, a flat insole of polyester resin was made, fitting it to the foot's size.

Timeline

• Start date: 2019-06-20
• Primary completion: 2020-05-15
• Completion: 2020-06-15
• First posted: 2020-07-08
• Last updated: 2021-04-14

Locations

1 site across 1 country: Spain