- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06677164
Gluteus Maximus Strengthening Exercises Augmented by High-Intensity Laser Therapy in Patients With Plantar Fasciopathy
March 13, 2025 updated by: Soad Ali, Deraya University
Gluteus Maximus Strengthening Exercises Augmented by High-Intensity Laser Therapy in Patients With Chronic Plantar Fasciopathy
Plantar heel pain is one of the most commonly encountered problems of the feet in adults [1].
It accounts for nearly 11%-15% of all foot symptoms, The purpose of this study was to investigate the effectiveness of high intensity laser therapy combined with gluteus Maximus strengthening exercise on pain, thickness of plantar fascia, and function of the foot.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
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
-
-
-
Minya, Egypt, 05673
- Deraya university
-
-
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:
- Unilateral plantar heel pain with or without calcaneal spur for more than 3 months.
- Tenderness at the insertion of the plantar fascia
- BMI index will be from 25 up to 30
- Patient will wear silicone insole .
- Diagnosis of PF based on orthopedic referral
Exclusion Criteria:
- Patients with presence of foot deformity,
- systemic inflammatory arthritis disease,
- foot surgery, or
- plantar heel pain due to trauma,
- wound, or infection in the foot,
- received oral corticosteroids
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: Experimental: High intensity laser therapy combined with Gluteus Maximus strengthening exercise
patients will receive High intensity laser therapy combined with Gluteus Maximus strengthening exercise
|
Maximus strengthening exercise for eight weeks using weight progression tools either elastic band or sand weight by assuming two modes of exercises (clamshell exercise, prone hip extension) with stretching exercise (hamstring, gastrocnemius, soleus, and plantar fascia) 2 sessions per week for 8 weeks
A 3-phase treatment program will be performed in each session on the plantar fascia area.
Treatment of trigger points in phase 1 and 2 by using power of 9 watts, E2C mode for 6 minute of 2 phases.
The draining and vascularization-promoting application involve the whole foot sole, starting from the heel area in phase three by using power of 9 watts, CW mode with energy of 100J/cm2.
|
|
Active Comparator: Active Comparator: High intensity laser therapy
patients will receive High intensity laser therapy.
|
A 3-phase treatment program will be performed in each session on the plantar fascia area.
Treatment of trigger points in phase 1 and 2 by using power of 9 watts, E2C mode for 6 minute of 2 phases.
The draining and vascularization-promoting application involve the whole foot sole, starting from the heel area in phase three by using power of 9 watts, CW mode with energy of 100J/cm2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain assessment
Time Frame: 3 months
|
Pressure algometry (kg/cm2).
Pressure algometry will be performed on both affected and healthy feet
|
3 months
|
|
Plantar fascia thickness
Time Frame: 3 months
|
by using Ultrasonography, in a longitudinal view of the tendon in both affected and healthy feet (mm).
the normal plantar fascia thickness is less than 4 mm
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 10, 2024
Primary Completion (Actual)
November 22, 2024
Study Completion (Actual)
December 1, 2024
Study Registration Dates
First Submitted
November 5, 2024
First Submitted That Met QC Criteria
November 5, 2024
First Posted (Actual)
November 6, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 13, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- physiotherapy 3
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
product manufactured in and exported from the U.S.
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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