Shock Waves Combined With Leg Stretches in Patients With Plantar Fasciitis

June 13, 2024 updated by: Guillem Serrabassa Ureña, University of Alcala

Efficacy of Applying Shock Waves Combined With Leg Stretches in Patients With Plantar Fasciitis: A Randomized Controlled Trial

The aim of this study is to evaluate the efficacy of a combination treatment consisting of ESWT and stretching of different muscles in the lower body compared to ESWT treatment alone in patients with plantar fasciitis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Plantar fasciitis is the most common cause of pain in the heel of the foot, manifested by the presence of pain in the antero-internal part of the calcaneus. Currently, there is ample evidence of the efficacy of both shock waves and stretching in their treatment, however, no study has proven what results are obtained by combining the application of shock waves with stretching in different leg muscles.

Objectives: The main objective of the study is to compare the effects of OC treatment in conjunction with leg-length stretches against shock waves alone in reducing pain in patients with PF. The secondary objectives will be to observe the effects of both treatments on disability and activity limitation in both the short and medium term.

Materials and Methods: A double-blind randomized clinical trial will be conducted. A total of 52 subjects (26 in each group) will participate in the study, divided into one group that will undergo shockwave therapy plus real stretching (experimental group) and another that will undergo shockwave therapy plus placebo stretching (control group). The primary variable of the study will be pain, and secondary variables will include changes in disability and activity limitation.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Comunidad De Madrid
      • Alcalá De Henares, Comunidad De Madrid, Spain, 28805
        • University of Alcalá, Faculty of Nursing and Physiotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Presence of pain in the medial area of the sole of the foot lasting 3 or more months.
  • Being diagnosed with plantar fasciitis by one of the physical therapists participating in the study.
  • Have a pain level equal to or greater than 3 on the Visual Analogue Scale (VAS).

Exclusion Criteria:

  • Presence of bilateral plantar fasciitis.
  • Signs of neurological abnormalities.
  • Infections and malignant tumors.
  • History of presence of dysfunction in the lower extremity.
  • Pregnant women
  • Have been treated with shock waves in the previous 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real Stretching
This group is goint to realize 3 sesions of ESWT plus an 8 weeks stretching program.
Other: Real stretching
Aplying 3 sesions of ESWT in patients with plantar fasciitis in the zone of pain. Futhermore they are going to do a program of 8 weeks stretching of plantar fascia, gastrocnemius and hamstring muscle.
Other Names:
  • Extracorporeal Shock Wave Threatment
Placebo Comparator: Placebo Stretching
This group is goint to realize 3 sesions of ESWT plus an 8 weeks stretching placebo program.
Other: Placebo stretching
Aplying 3 sesions of ESWT in patients with plantar fasciitis in the zone of pain. Futhermore they are going to do a program of 8 weeks placebo stretching of plantar fascia, gastrocnemius and hamstring muscle.
Other Names:
  • Extrecorporeal Shock Wave Threatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intenisty
Time Frame: Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention
To evaluate the difference in pain after the intervention. We are going to use the Visual Analogue Scale, being 0 the better result and 10 the worst possible, We are also going to use the Pain Scale for Plantar Fasciitis in their seccion for pain masure. The minimum score is 0 (better) and the maximum 100 (worst).
Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention
To evaluate the difference in disability after the intervention. The Foot Function Index is going to be used in order to evaluate the disability, in its section intended for this. This scale gives a result in %, the highest the % is the worst.
Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity limitation
Time Frame: Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention

To evaluate the difference in activity limitation after the intervention. The Foot Function Index is going to be used in order to evaluate the activity limitation, in its section intended for this. This scale gives a result in %, the highest the % is the worst.

The Foot and Ankle Ability Measures is also goint to be used to evaluate activity limitation. It's section destinated to evaluate this item fives a number that goes from 0 to 84. This number must be divided by 100 to get de final %. The highest the % is, the better.
Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Investigators

  • Principal Investigator: Guillem Serrabassa Ureña, MSc, University of Alcala
  • Principal Investigator: Tomás Gallego Izquierdo, PhD, University of Alcala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDCES-08969382A

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Plantar Fascitis

Clinical Trials on Real stretching

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe