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

NCT04461197 | Completed

• 1 other identifier: CRESEUE-Foot 2
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Fasciitis, Plantar, Chronic

Keywords

Fasciitis, Plantar; Foot Orthoses; High-Energy Shock Waves

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Roles-Maudsley (RM) scores

  Baseline

Study Arms (2)

ESWT + orthotic insole

EXPERIMENTAL

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

Device: customised foot orthoses

ESWT + flat insole

PLACEBO COMPARATOR

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

Device: orthotic insole

Interventions

customised foot orthoses DEVICE

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.

ESWT + orthotic insole

orthotic insole DEVICE

For group B, a flat insole of polyester resin was made, fitting it to the foot's size.

ESWT + flat insole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Universidad de Sevilla

Seville, Spain

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Ana J Perez, Dra.

  University of Seville

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 8, 2020
• Study Start: June 20, 2019
• Primary Completion: May 15, 2020
• Study Completion: June 15, 2020
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)