- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07526012
Comparative Effects Of Post Isometric Relaxation Versus Active Isolated Stretch In Patients With Piriformis Syndrome
The purpose of this study is to evaluate the comparative effects of post-isometric relaxation (PIR) and active isolated stretch (AIS) techniques on reducing pain, improving range of motion, and decreasing functional disability in individuals with piriformis syndrome. A total of 40 participants will be recruited, aged 20-55 yrs, with confirmed piriformis syndrome. Participants will be randomized into two equal groups. Group A (post isometric relaxation) and Group B (active isolated stretch). Both groups will receive Conventional Therapy (Thermotherapy, Electrotherapy).
Study variables include:
- Independent Variable: Post Isometric Relaxation and Active Isolated Stretching.
- Dependent Variables: Pain (measured by Visual Analog Scale), Functional Disability (assessed via Oswestry Disability Index), Range of Motion (assessed via Goniometer).
- Control Variables: Age, Gender, BMI, Baseline Pain/ Disability Scores/ROM
The intervention will last 2 weeks with 6 sessions (3 sessions per week). Assessments will be conducted at baseline (Week 1, Pre-treatment) and Post every second session. Data will be analyzed to compare immediate and short-term effects of the two interventions.
This study aims to provide evidence for targeted manual therapy approaches in priformis syndrome, potentially guiding clinicians toward the most effective technique for pain reduction, improve ROM and decrease functional disability.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This Randomized Controlled Trial aims to effects of post-isometric relaxation (PIR) and active isolated stretch (AIS) techniques on reducing pain, improving range of motion, and decreasing functional disability in individuals with piriformis syndrome.
A Total of 40 participants will be recruited and randomized equally into two groups.
- Group A: Post Isometric Relaxation
- Group B: Active Isolated Stretching
Both groups will additionally receive conventional management (TENs, Heating).
INTERVENTION SCHEDULE:
- Duration: 2 weeks
- Frequency: 3 Sessions/week
- Total Sessions: 6 Sessions per participant
Group A (PIR): In this group, participant is asked to performed an isometric contraction in supine lying position with one leg crossed over the other, in which participant contracts the targeted muscle against resistance for about 6 to 10 seconds, followed by a relaxation phase of approximately 3 seconds Group B (AIS): In this group participant actively moves the limb to the end range of motion, followed by a brief, 1-2 second stretch applied by the therapist. Move the non-exercising leg across midline and rotate inward. The exercising leg is flexed at a 90° angle at the knee. Move the knee close to the opposite-side breast. Clasp the knee with the near hand and the top of the ankle with the far side hand. Rotate the thigh outward, moving the loot toward the surface with the far-side hand. This process is repeated for 8-10 repetitions.
ASSESSMENTS:
- Conducted at Baseline (Pre-Intervention) and post-intervention (end of week 2)
- Outcomes: Pain Intensity (VAS), Functional Disability (Oswestry Disability Index), ROM (Goniometer)
DATA ANALYSIS:
Intra-group comparisons (Pre vs Post) and Inter-group comparisons (PIR vs AIS) will be performed at the end of the 2-week intervention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Furqan Hassan, MS-OMPT
- Phone Number: 0333-4056768
- Email: furqan.hassan@fui.edu.pk
Study Contact Backup
- Name: Parsa Saghir, DPT
- Phone Number: 0315-8962525
- Email: parsa.saghir@gmail.com
Study Locations
-
-
Punjab Province
-
Islamabad, Punjab Province, Pakistan, 46000
- Recruiting
- Foundation University College of Physical Therapy
-
Contact:
- Muhammad Furqan Hassan, MS-OMPT
- Phone Number: 0333-4056768
- Email: furqan.hassan@fuie.edu.pk
-
Contact:
- Parsa Saghir, DPT
- Phone Number: 0315-8962525
- Email: parsa.saghir@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 20-55 years
- Both genders
- Buttock pain that may radiates to posterior thigh but not beyond the knee
- Pain aggravated by sitting, climbing stairs or hip rotation.
- Tenderness upon palpation over the sciatic foramen.
- Positive FAIR test.
Exclusion Criteria:
- Malignancies
- History of steroid therapy over 3 months
- Rheumatoid arthritis or osteoarthritis
- Avascular necrosis of the femoral head
- Osteoporosis
- Fracture of the femur
- Hip deformity
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 |
|---|---|
|
Active Comparator: Group A - Post Isometric Relaxation
Participants allocated to this arm will receive Post Isometric Relaxation.
Each participant will undergo 6 sessions over 2 weeks (3 Sessions/week), and receive Conventional Physiotherapy
|
Participants allocated to this arm will receive Post Isometric Relaxation.
Each participant will undergo 6 sessions over 2 weeks (3 Sessions/week), and receive Conventional Physiotherapy
|
|
Experimental: Group B - Active Isolated Stretch
Participants allocated to this arm will receive Active Isolated Stretching.
Each participant will undergo 6 sessions over 2 weeks (3 Sessions/week), and receive Conventional Physiotherapy
|
Participants allocated to this arm will receive Active Isolated Stretching.
Each participant will undergo 6 sessions over 2 weeks (3 Sessions/week), and receive Conventional Physiotherapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Before Treatment and after 2 weeks.
|
The Visual Analog Scale (VAS) will be used to measure the intensity of pain before and after the intervention. Participants will mark their level of pain on a 100 mm horizontal line, where: 0 mm indicates "no pain", and 100 mm indicates "the worst imaginable pain". |
Before Treatment and after 2 weeks.
|
|
Range of Motion
Time Frame: Before treatment and after 2 weeks
|
A universal goniometer will be used to assess hip mobility in: Internal Rotation. ROM will be recorded in degrees. |
Before treatment and after 2 weeks
|
|
Functional Disability
Time Frame: Before treatment and after 2 weeks
|
Oswestry Disability Index (ODI) It is used to measure functional disability. The Oswestry Disability Index (ODI) is one of the condition-specific questionnaires recommended for use with back pain patients. Interpretation: 0-20%: Minimal disability. 21-40%: Moderate disability. 41-60%: Severe disability (needs investigation). 61-80%: Crippled (needs active treatment). 81-100%: Bed-bound or exaggerating. |
Before treatment and after 2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Parsa Saghir, DPT, Foundation University Islamabad
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Pelvic Pain
- Back Pain
- Mononeuropathies
- Nerve Compression Syndromes
- Sciatic Neuropathy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Low Back Pain
- Piriformis Muscle Syndrome
Other Study ID Numbers
- FUI/FUCP/CTR/02.26/Parsa
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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