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NCT Number: NCT04461197

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

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.

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Key information

Conditions

Fasciitis, Plantar, Chronic Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Sevilla

Seville, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Orthotic Insole

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Roles-Maudsley (RM) scores

    Time frame: Baseline

    This is a self-administered scale of functional valuation which classifies the patients into 4 categories

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 8, 2020
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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