- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07255053
Comparative Effects of PIR and PFS on Pain, Hip ROM, and Disability in Piriformis Syndrome (PIR-PFS RCT)
Comparative Effects of Post Isometric Relaxation and Post Facilitation Stretching on Pain Reduction Hip Abduction and Internal Rotation Range, and Functional Disability in Patients With Piriformis Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Piriformis Syndrome (PS) is a musculoskeletal condition characterized by pain in the buttock and hip, sometimes radiating to the lower back and thigh. It may arise from anatomical variations affecting the sciatic nerve, inflammation, hypertrophy, muscle spasms, or shortening of the piriformis muscle. PS can significantly reduce hip range of motion and functional capacity, affecting patients' quality of life.
This randomized clinical trial aimed to compare the effectiveness of two rehabilitation techniques, Post-Isometric Relaxation (PIR) and Post-Facilitation Stretching (PFS), in managing pain, improving hip abduction and internal rotation, and enhancing functional capacity in patients with PS. Thirty-six participants aged 35-55 years, of both genders, diagnosed with sub-acute or chronic PS, and meeting specific clinical criteria, were randomly assigned to either intervention group.
Inclusion criteria included positive findings on at least three of the following tests: Piriformis, Beatty, Freiberg, FAIR, Sign of Pace, and Nagel tonic external rotation of hip; bilateral buttock pain due to sciatic nerve or piriformis muscle spasm; NPRS pain score of 3-7; tenderness over the sciatic foramen; and willingness to participate. Exclusion criteria included spinal, hip, knee, or SI joint pathology, prior spinal surgery or vertebral fracture, systemic disease, limb length discrepancy, postural deformities (e.g., scoliosis), hip dislocation or femoral fracture, and any psychological conditions.
Group A (PIR) participants performed exercises lying supine with the affected leg flexed, pelvis stabilized, and piriformis muscle activated through resisted abduction. Group B (PFS) participants performed combined stretching and isometric contractions with the involved leg positioned in hip flexion, adduction, and external rotation. Interventions were conducted over a 4-week period.
Assessments were conducted at baseline and six weeks using:
Numeric Pain Rating Scale (NPRS) to quantify pain intensity
Goniometer - to measure hip abduction and internal rotation range
Lower Extremity Functional Scale (LEFS) to assess functional disability; a 20-item scale rated on a Likert scale (total score 0-80), with lower scores indicating greater disability
The objective of this study was to determine which rehabilitation technique, PIR or PFS, is more effective in alleviating pain, improving hip range of motion, and enhancing functional outcomes, ultimately aiming to improve the quality of life for patients diagnosed with Piriformis Syndrome.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
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Faisalābad, Punjab Province, Pakistan, 38000
- The University of Faisalabad
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants aged 35-55 years Both genders Positive findings on three or more of the following tests: Piriformis, Beatty, Freiberg, FAIR, Sign of Pace, Nagel tonic external rotation of hip Bilateral buttock pain caused by compression of the sciatic nerve or piriformis muscle spasm NPRS pain score between 3 and 7 Tenderness to palpation over the sciatic foramen Diagnosed sub-acute or chronic Piriformis Syndrome Willing to participate
Exclusion Criteria:
- Any pathology or recent injury around the hip, knee, or SI joint, or radiating pain from the spine, SI joint, or hip History of spinal surgery or vertebral fracture History of systemic disease, stroke, leprosy, or amputation Leg pain not related to Piriformis Syndrome (e.g., disc herniation, sacroiliac joint dysfunction, degenerative joint disease) History of spinal injury, joint disease, or congenital abnormalities Limb length difference SI joint dysfunction Hip joint dislocation or femoral fracture Any postural deformity or anomaly (e.g., scoliosis) Psychologically diagnosed condition
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: Post Isometric Relaxation (PIR)
Type of technique: Muscle Energy Technique (MET) Patient position: Supine, affected leg flexed at hip and knee, crossed over the other leg, foot resting on the table Pelvis stabilization: Therapist hand on opposite ASIS to prevent pelvic movement Leg positioning: Other hand on lateral aspect of the knee Finding the barrier: Knee moved into abduction until first sign of resistance (pain-free end range) Isometric contraction: Patient pushes against the therapist's hand at ~20% strength for 7-10 seconds Relaxation and stretch: After contraction, leg moved slightly further into abduction Repetitions: 3 times per session |
Participants received PIR exercises targeting the piriformis muscle three days per week for 4 weeks.
The technique involved pain-free isometric contractions followed by gentle stretching to improve hip abduction and internal rotation
Other Names:
|
|
Experimental: Post Facilitation Stretching (PFS)
Patient position: Supine, affected leg slightly adducted and externally rotated, hip flexed >60° Therapist hand placement: Inferior hand on table for support, superior hand guides leg movement Muscle positioning: Piriformis placed in intermediate range (between full stretch and rest) Isometric contraction: Patient externally rotates leg against resistance for 10 seconds Pause / Rest phase: 30-second relaxation after contraction; therapist applies deeper stretch into adduction and external rotation Next barrier: Leg gently moved to new barrier Repetitions: 3 times per session |
Participants received PFS exercises targeting the piriformis muscle three days per week for 4 weeks.
The technique combined isometric contractions with controlled stretching to enhance hip mobility and reduce pain.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity in patients with Piriformis Syndrome
Time Frame: Baseline and 4 weeks after intervention completion
|
Pain was measured using the Numeric Pain Rating Scale (NPRS), a 0-10 scale where 0 indicates no pain and 10 indicates worst possible pain.
|
Baseline and 4 weeks after intervention completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hip Abduction and Internal Rotation Range of Motion
Time Frame: Baseline and 4 weeks after intervention completion
|
Hip range of motion was measured using a goniometer to assess internal rotation and abduction angles.
|
Baseline and 4 weeks after intervention completion
|
|
Functional Disability
Time Frame: Baseline and at 4 weeks after intervention completion
|
Functional capacity was assessed using the Lower Extremity Functional Scale (LEFS), a 20-item questionnaire evaluating lower limb function in daily activities.
Lower scores indicate greater disability
|
Baseline and at 4 weeks after intervention completion
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- TUF-PIRIFORMIS-RCT-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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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