- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07487753
Instrumental Soft Tissue Mobilization and Foam Rolling (IASTM)
The Role of Instrumental Soft Tissue Mobilization and Foam Rolling in Managing Plantar Fasciitis: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized comparative study was conducted to evaluate the effectiveness of instrument-assisted soft tissue mobilization (IASTM) and foam roller therapy in the management of plantar fasciitis. Plantar fasciitis is a common musculoskeletal condition characterized by heel pain and reduced functional mobility, often associated with restricted ankle dorsiflexion and plantar fascia tightness.
Participants diagnosed with plantar fasciitis were recruited from a physiotherapy outpatient department and randomly allocated into two intervention groups. Group A received instrument-assisted soft tissue mobilization applied to the plantar fascia and surrounding soft tissues along with a structured exercise program. Group B received foam roller therapy targeting the plantar fascia region in addition to the same exercise protocol. Both interventions were administered over a defined treatment period under physiotherapist supervision.
The study aimed to compare the effects of these interventions on pain intensity, ankle dorsiflexion range of motion, and functional disability related to plantar fasciitis. Measurements were obtained at baseline and after completion of the intervention period. The findings of this study may help identify effective physiotherapy interventions for improving pain and functional outcomes in individuals with plantar fasciitis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Haryana
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Faridabad, Haryana, India, 121004
- MRIIRS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Age between 18 and 45 years
- Pain on palpation at the medial tuberosity of the calcaneus
- Pain during the first steps in the morning that decreases after walking
- Symptoms present for more than one month
- Both male and female participants were included Exclusion Criteria
- History of foot surgery
- Inflammatory rheumatic disease
- Previous steroid injection
- Radiculopathy affecting the lower limb
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
IASTM + Exercise
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Instrument-assisted soft tissue mobilization applied to the plantar fascia and surrounding soft tissues to improve tissue mobility and reduce pain.
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Active Comparator: 2
Foam Roller + Exercise
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Self-myofascial release using a foam roller applied to the plantar fascia region to reduce pain and improve flexibility.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity measured using the Numeric Pain Rating Scale (NPRS)
Time Frame: Pre (baseline) and Post (4 weeks)
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Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).
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Pre (baseline) and Post (4 weeks)
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Ankle dorsiflexion range of motion measured in degrees using a goniometer
Time Frame: Pre (baseline) and Post (4 weeks)
|
Ankle range of motion will be measured in degrees using a universal goniometer.
|
Pre (baseline) and Post (4 weeks)
|
|
Health-related quality of life measured using the Short Form-36 (SF-36) questionnaire
Time Frame: Pre (baseline) and Post (4 weeks)
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Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire, which evaluates physical and mental health domains.
Each domain is scored separately and then transformed to a 0-100 scale, where higher scores indicate better health status and quality of life.
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Pre (baseline) and Post (4 weeks)
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Foot pain and disability measured using the Foot Function Index (FFI)
Time Frame: Pre (baseline) and Post (4 weeks)
|
Foot function and disability related to plantar fasciitis were measured using the Foot Function Index (FFI) questionnaire.
Each item of the Foot Function Index (FFI) is rated on a Visual Analog Scale (VAS) from 0 to 10, where 0 indicates no pain or difficulty and 10 indicates the worst pain or extreme difficulty.
Scores for the answered items in each subscale are summed and divided by the maximum possible score for that subscale, and the result is multiplied by 100 to obtain a percentage score (FFI Score = Sum of item scores / Maximum possible score × 100).
The scores range from 0% to 100%, where 0% represents no pain or disability and 100% represents maximum pain and disability.
Higher scores indicate greater pain, functional limitation, and disability related to foot problems.
A total FFI score can be calculated by averaging the three subscale scores: Pain, Disability, and Activity Limitation.
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Pre (baseline) and Post (4 weeks)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IASTMvsFR
- MRIIRS/SAHS/PT/2024-25/009 (Other Grant/Funding Number: MRIIRS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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