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

Primary Purpose

Fasciitis, Plantar, Chronic

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
customised foot orthoses
orthotic insole
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fasciitis, Plantar, Chronic focused on measuring Fasciitis, Plantar, Foot Orthoses, High-Energy Shock Waves

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad de Sevilla

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ESWT + orthotic insole

ESWT + flat insole

Arm Description

(shock waves + orthotic insole +Stretches of the posterior muscle chain)

(shock waves + flat insole + Stretches of the posterior muscle chain)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Roles-Maudsley (RM) scores
This is a self-administered scale of functional valuation which classifies the patients into 4 categories

Full Information

First Posted
June 26, 2020
Last Updated
April 13, 2021
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT04461197
Brief Title
Efficacy of the Treatment of Plantar Orthoses With Extracorporeal Shock Wave Therapy in Plantar Fasciitis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasciitis, Plantar, Chronic
Keywords
Fasciitis, Plantar, Foot Orthoses, High-Energy Shock Waves

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESWT + orthotic insole
Arm Type
Experimental
Arm Description
(shock waves + orthotic insole +Stretches of the posterior muscle chain)
Arm Title
ESWT + flat insole
Arm Type
Placebo Comparator
Arm Description
(shock waves + flat insole + Stretches of the posterior muscle chain)
Intervention Type
Device
Intervention Name(s)
customised foot orthoses
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
orthotic insole
Intervention Description
For group B, a flat insole of polyester resin was made, fitting it to the foot's size.
Primary Outcome Measure Information:
Title
visual analog scale (VAS)
Description
Heel pain intensity was referred to as 0-10, in which 0= no pain at all and 10= the worst pain possible
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Roles-Maudsley (RM) scores
Description
This is a self-administered scale of functional valuation which classifies the patients into 4 categories
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana J Perez, Dra.
Organizational Affiliation
University of Seville
Official's Role
Study Director
Facility Information:
Facility Name
Universidad de Sevilla
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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