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

NCT06174142 | Unknown

• 1 other identifier: FAlkalbani
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Functional Improvement

  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).

Study Arms (3)

High-Frequency ESWT Group

EXPERIMENTAL

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

Low-Frequency ESWT Group

EXPERIMENTAL

Experimental

Device: Low-Frequency ESWT Group

Sham ESWT Control Group

SHAM COMPARATOR

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

Interventions

High-Frequency ESWT DEVICE

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

High-Frequency ESWT Group

Low-Frequency ESWT Group DEVICE

"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."

Low-Frequency ESWT Group

Sham ESWT Control Group DEVICE

"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."

Sham ESWT Control Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sharjah: lead

Related Publications (18)

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MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Fatima Alkalbani, Bsc

  PRS User

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatima Alkalbani, Bsc

CONTACT

971507132332; fatimaalkalbani1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In a randomized trial, two shock wave therapies for plantar fasciitis are tested. Group A gets high-frequency (15 Hz), Group B low-frequency (10 Hz, higher intensity), and Group C receives sham therapy. The study aims to measure pain relief and functional gains post six treatments, with follow-ups to assess benefits' persistence.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: December 18, 2023
• Study Start: December 20, 2023
• Primary Completion: January 5, 2024
• Study Completion: January 25, 2024
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share