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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04461197
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
MANUEL PABON CARRASCO, University of Seville

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.


Condition or disease Intervention/treatment Phase
Fasciitis, Plantar, Chronic Device: customised foot orthoses Device: orthotic insole Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health Shock

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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Roles-Maudsley (RM) scores [ Time Frame: Baseline ]
    This is a self-administered scale of functional valuation which classifies the patients into 4 categories



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Manuel coheña, Dr. 646966913 mcohena@us.es

Locations
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Spain
Universidad de Sevilla Recruiting
Sevilla, Spain
Contact: Ana J Perez, Dra.         
Sponsors and Collaborators
University of Seville
Investigators
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Study Director: Ana J Perez, Dra. University of Seville
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Responsible Party: MANUEL PABON CARRASCO, Principal Investigator, University of Seville
ClinicalTrials.gov Identifier: NCT04461197    
Other Study ID Numbers: CRESEUE-Foot 2
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MANUEL PABON CARRASCO, University of Seville:
Fasciitis, Plantar
Foot Orthoses
High-Energy Shock Waves
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases