- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07070245
- Original Trial
Comparing Instrument Assisted Soft Tissue Mobilization With Positional Release Technique for Plantar Fasciitis Pain and Range of Motion
July 15, 2025 updated by: Doaa Said Mohamed Ibrahim
Chronic plantar fasciitis (CPF) is the most common cause of chronic heel pain in adults, affecting both young active patients and older, more sedentary individuals.
It results from chronic overload of the plantar fascia.
This overload may be due to overuse, as seen in runners and military personnel, or due to excessive loading in individuals with obesity (body mass index >30), sedentary lifestyles, or occupations that require prolonged standing.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
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
-
-
-
Port Said, Egypt
- Faculty of Physical Therapy
-
-
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:
- Clinically diagnosed cases of plantar fasciitis not less than 3 months.
- Heel pain felt maximally over plantar aspect of heel.
- Pain in the heel on the first step in the morning.
- Their age ranging from 30 to 50 years
Exclusion Criteria:
- Subjects can't tolerate close physical contact (Kotwalkar et al., 2019).
- Athletes.
- Subjects with skin infections (Kotwalkar et al., 2019).
- Subjects with recent fracture with incomplete bony union (Rowlett et al., 2018).
- Subjects with acute inflammatory or infectious process (Rowlett et al., 2018).
- Subjects with hematoma (Rowlett et al., 2018).
- Subjects with osteoporosis (Looney et al., 2011).
- Subjects with foot deformity (Kotwalkar et al., 2019).
- Subjects that take medications that may increase blood clotting (Kotwalkar et al., 2019).
- Surgery to the ankle or foot (Looney et al., 2011).
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: Positional release technique
Positional release technique in addition to exercises in form of stretching exercises for plantar fascia, gastrocnemius, soleus muscles, and short foot exercise (study group) The treatment protocol will be two sessions.
given per week for 4 weeks.
|
The treatment protocol will be two sessions.
given per week for 4 weeks.
|
|
Experimental: Traditional exercises (control group)
Traditional exercises (control group), traditional exercises in form of stretching exercises for plantar fascia, gastrocnemius, soleus muscles, and short foot exercise The treatment protocol will be two sessions. given per week for 4 weeks. |
The treatment protocol will be two sessions.
given per week for 4 weeks.
|
|
Experimental: Instrument assisted soft tissue mobilization
Instrument-assisted soft tissue mobilization in addition to exercises (study group) in form of stretching exercises for plantar fascia, gastrocnemius, soleus muscles, and short foot exercise
|
The treatment protocol will be two sessions.
given per week for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity level assessed by Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline and after 8 sessions (approximately 4 weeks)
|
Pain intensity level assessed by Numeric Pain Rating Scale.
A scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain intensity.
|
Baseline and after 8 sessions (approximately 4 weeks)
|
|
Range of motion
Time Frame: Baseline and after 8 sessions (approximately 4 weeks)
|
A digital goniometer is used for the assessment of ankle dorsiflexion, plantar flexion range of motion, and knee flexion range of motion.
|
Baseline and after 8 sessions (approximately 4 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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)
June 22, 2025
Primary Completion (Estimated)
September 22, 2025
Study Completion (Estimated)
October 1, 2025
Study Registration Dates
First Submitted
July 5, 2025
First Submitted That Met QC Criteria
July 15, 2025
First Posted (Actual)
July 17, 2025
Study Record Updates
Last Update Posted (Actual)
July 17, 2025
Last Update Submitted That Met QC Criteria
July 15, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- No:P.T.REC/012/005492
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data (IPD) will not be shared due to privacy concerns and limitations in data-sharing agreements.
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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