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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Device: High-Frequency ESWT
* Device: Low-Frequency ESWT Group
* Device: Sham ESWT Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participants should present with unilateral pain The participants' age will be ranged from 20-50 years old. The participants should have the pain from for at least 6 weeks. Moderate disability as assessed by the foot function index (FFI) The Body Mass Index (BMI) should be normal. The participants should have pronated feet (6-9 on the foot posture index) Exclusion Criteria: History of surgery or fracture History of corticosteroid injection within 6 months Unable to follow or understand the instructions High BMI Severe foot pronation (+10 on the foot posture index)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This randomized trial compares two shock wave therapy protocols in plantar fasciitis treatment against a sham control. Group A receives high-frequency therapy (15 Hz, intensity level 3), Group B low-frequency (10 Hz, intensity level 4), and Group C a sham treatment, all alongside physical therapy. The goal is to evaluate pain reduction and functional improvement after six sessions, with follow-up assessments to gauge effect durability.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-Frequency ESWT Group<br>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<br>* 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<br>|
| Experimental: Low-Frequency ESWT Group<br>Experimental | Device: Low-Frequency ESWT Group<br>* 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.<br>|
| Sham Comparator: Sham ESWT Control Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Reduction | 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 | 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). |