Comparing Two Protocols of Shock Wave Therapy for Patients With Plantar Fasciitis

December 7, 2023 updated by: Fatima Alkalbani, University of Sharjah

A Randomized Controlled Trial Comparing Two Protocols of Shock Wave Therapy for Patients With Plantar Fasciitis

The goal of this clinical trial is to compare the efficacy of two distinct shock wave therapy protocols and their impact on improving function and reducing pain in individuals with plantar fasciitis, a common cause of heel pain that affects millions worldwide.

The key questions the study aims to address are:

How effective is each shock wave therapy protocol in enhancing functional ability without pain in patients with plantar fasciitis? Does either protocol offer a significant benefit over the other in terms of pain relief and functional improvement after a course of six treatment sessions?

Participants will be randomly assigned to one of three groups and will engage in the study as follows:

Undergo six sessions of shock wave therapy with parameters specific to their assigned group.

Complete questionnaires assessing foot function and pain levels. Participate in evaluations before, during, and after the treatment to monitor their progress.

The three groups in the comparison are as follows:

Group A will receive shock wave therapy at a higher frequency and specific intensity, with a set number of impulses.

Group B will undergo therapy with a different frequency and intensity level but will receive the same number of impulses.

Group C, the control group, will receive a sham therapy, mirroring the treatment experience without the therapeutic effects to serve as a baseline for comparison.

The study is anticipated to delineate a more effective protocol for treating plantar fasciitis with shock wave therapy. The findings may contribute to enhanced treatment guidelines, potentially resulting in faster recovery times for patients. The participation of individuals in this research will offer valuable insights that could inform future therapeutic strategies for managing plantar fasciitis

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial is designed to evaluate the efficacy of two distinct shock wave therapy protocols in treating plantar fasciitis, a condition that causes heel pain and can severely impact daily activities. The aim is to discern which protocol is more effective at improving functional abilities and reducing pain.

Plantar fasciitis typically manifests as a sharp pain at the bottom of the heel, often affecting individuals who engage in high-impact activities such as running. With the variability in treatment approaches, shock wave therapy has been recognized as a promising, non-invasive treatment method. The study seeks to address the current gaps in research by identifying the most beneficial treatment parameters of shock wave therapy.

Participants will be randomly allocated to one of three groups:

Group A will receive shock wave therapy with high-frequency settings. Group B will receive shock wave therapy with low-frequency settings but higher intensity.

Group C will serve as a control group, receiving sham shock wave therapy to provide a baseline for comparison.

All groups will partake in a consistent regimen of physical therapy exercises, ensuring that any differences in outcomes are attributable to the shock wave therapy parameters. The inclusion of these exercises is crucial as they contribute to recovery by stretching and strengthening the affected area.

To maintain the integrity of the trial, participants will be blinded to the shock wave therapy parameters they receive, thereby reducing potential bias. The study will feature comprehensive assessments at various points: before the intervention, halfway through the sessions, upon completion of the therapy, and during a follow-up phase to assess the durability of the effects.

The trial is anticipated to yield significant insights into the effectiveness of different shock wave therapy protocols, which will be instrumental in developing more refined treatment guidelines. Ultimately, these findings could enhance the quality of life for individuals with plantar fasciitis and guide clinical practice for the treatment of associated heel pain.

Study Type

Interventional

Enrollment (Estimated)

64

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 Contact

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The participants should present with unilateral pain
  2. The participants' age will be ranged from 20-50 years old.
  3. The participants should have the pain from for at least 6 weeks.
  4. Moderate disability as assessed by the foot function index (FFI)
  5. The Body Mass Index (BMI) should be normal.
  6. The participants should have pronated feet (6-9 on the foot posture index)

Exclusion Criteria:

  1. History of surgery or fracture
  2. History of corticosteroid injection within 6 months
  3. Unable to follow or understand the instructions
  4. High BMI
  5. Severe foot pronation (+10 on the foot posture index)

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-Frequency ESWT Group
This arm will receive extracorporeal shockwave therapy (ESWT) with a higher frequency setting of 15 Hz and an intensity/pressure of level 3. Participants will receive a total of 1800 impulses per session for 6 sessions, with one session per week, alongside a selected physical therapy program.
Device: High-Frequency ESWT
Participants will receive extracorporeal shock wave therapy at a frequency of 15 Hz and intensity/pressure level 3, with a total of 1800 impulses per session. This intervention will be conducted once per week for six weeks, alongside a standard physical therapy regimen
Experimental: Low-Frequency ESWT Group
Experimental
Device: Low-Frequency ESWT Group
"Participants will be treated with extracorporeal shock wave therapy at a frequency of 10 Hz and intensity/pressure level 4, also with a total of 1800 impulses per session. This protocol will be delivered weekly for six sessions, accompanied by standardized physical therapy exercises."
Sham Comparator: Sham ESWT Control Group
Participants in the control group will undergo a sham shockwave therapy protocol, which simulates ESWT treatment without actual therapeutic effects, to serve as a comparison for the active treatments. They will also engage in the same physical therapy program as the other two arms.
Device: Sham ESWT Control Group
"Participants in this control group will undergo a sham ESWT procedure that mimics the treatment experience without actual therapeutic effects, ensuring the blinding of participants. This sham therapy will be scheduled once a week for six weeks, in conjunction with the same physical therapy program as the other groups."

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Reduction
Time Frame: Baseline: Assessment before the start of intervention (Week 0). Mid-Point: After the 3rd session (end of Week 3). End of Treatment: After the 6th session (end of Week 6). Follow-Up: 12 weeks post-intervention (end of Week 18).
Evaluate the decrease in heel pain as measured by the Visual Analog Scale (VAS).
Baseline: Assessment before the start of intervention (Week 0). Mid-Point: After the 3rd session (end of Week 3). End of Treatment: After the 6th session (end of Week 6). Follow-Up: 12 weeks post-intervention (end of Week 18).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Improvement
Time Frame: Baseline: Assessment before the start of intervention (Week 0). Mid-Point: After the 3rd session (end of Week 3). End of Treatment: After the 6th session (end of Week 6). Follow-Up: 12 weeks post-intervention (end of Week 18).
Measure the change in foot function using the Foot Function Index (FFI).
Baseline: Assessment before the start of intervention (Week 0). Mid-Point: After the 3rd session (end of Week 3). End of Treatment: After the 6th session (end of Week 6). Follow-Up: 12 weeks post-intervention (end of Week 18).

Collaborators and Investigators

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

Sponsor

University of Sharjah

Investigators

  • Principal Investigator: Fatima Alkalbani, Bsc, PRS User

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 (Estimated)

December 20, 2023

Primary Completion (Estimated)

January 5, 2024

Study Completion (Estimated)

January 25, 2024

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Estimated)

December 18, 2023

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAlkalbani

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no current plan to share individual participant data collected during this trial outside of the study team and the immediate research purposes outlined in the protocol. Data sharing decisions will be revisited upon study completion and publication of results, considering participant consent, data sensitivity, and ethical considerations

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.

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