Efficacy of the Treatment of Plantar Orthoses With Extracorporeal Shock Wave Therapy in Plantar Fasciitis
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|ClinicalTrials.gov Identifier: NCT04461197|
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Fasciitis, Plantar, Chronic||Device: customised foot orthoses Device: orthotic insole||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of the Therapeutic Effects of Adjunctive Treatment of Plantar Orthoses With Extracorporeal Shock Wave Therapy in Plantar Fasciitis: a Randomized Clinical Trial.|
|Actual Study Start Date :||March 20, 2020|
|Estimated Primary Completion Date :||July 15, 2020|
|Estimated Study Completion Date :||August 15, 2020|
Experimental: ESWT + orthotic insole
(shock waves + orthotic insole +Stretches of the posterior muscle chain)
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.
Placebo Comparator: ESWT + flat insole
(shock waves + flat insole + Stretches of the posterior muscle chain)
Device: orthotic insole
For group B, a flat insole of polyester resin was made, fitting it to the foot's size.
- visual analog scale (VAS) [ Time Frame: Baseline ]Heel pain intensity was referred to as 0-10, in which 0= no pain at all and 10= the worst pain possible
- Roles-Maudsley (RM) scores [ Time Frame: Baseline ]This is a self-administered scale of functional valuation which classifies the patients into 4 categories
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04461197
|Contact: Manuel coheña, Dr.||firstname.lastname@example.org|
|Universidad de Sevilla||Recruiting|
|Contact: Ana J Perez, Dra.|
|Study Director:||Ana J Perez, Dra.||University of Seville|