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.

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.

Study Overview

• Status: Completed
• Conditions: Fasciitis, Plantar, Chronic
• Intervention / Treatment: Device: customised foot orthoses; Device: orthotic insole

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain
    • Universidad de Sevilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 - 65 years
• able to understand the explanations about the potential benefits and risks of participating in the study
• both genders
• diagnosis of chronic plantar fasciitis
• duration of symptoms equal or superior to 6 months at the time of enrollment
• Foot Posture Index ≥ +6 (pronated foot in one or both feet).

Exclusion Criteria:

• being younger than 18 years of age
• previous treatments with shock wave devices
• previous surgery on the painful heel; history of calcaneus fracture
• any inflammation at the level of the ankle
• infection in the treated area
• patients with diabetes mellitus or cardiac or respiratory disease
• osteomyelitis
• patients on anticoagulant drugs
• pregnancy
• patients on immunosuppressive therapy
• rheumatoid arthritis or history of rheumatic disease
• neurological deficits
• malignant disease with or without metastases
• significant liver function abnormalities
• neurological or vascular insufficiency in the painful heel; fasciotomy or heel spur surgery
• discrepancy in the length of the foot > 5 mm; previous back of foot surgery
• patients treated with rigid plantar supports

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale (VAS)	Heel pain intensity was referred to as 0-10, in which 0= no pain at all and 10= the worst pain possible	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roles-Maudsley (RM) scores	This is a self-administered scale of functional valuation which classifies the patients into 4 categories	Baseline

Collaborators and Investigators

• Sponsor: University of Seville
• Investigators: Study Director: Ana J Perez, Dra., University of Seville

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2019
• Primary Completion (Actual): May 15, 2020
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: High-Energy Shock Waves; Foot Orthoses; Fasciitis, Plantar
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: CRESEUE-Foot 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No