- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06534788
Effects of Reciprocal Inhibition Versus Post Facilitation Muscle Energy Technique Along With Conventional Physical Therapy in Patients With Piriformis Syndrome: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to compare the effects of reciprocal inhibition with post facilitation muscle energy technique along with conventional physical therapy in terms of pain, functional disability and range of motion at hip joint in patients with piriformis syndrome to find the best suitable and effective treatment for it based on the outcomes.
Males and females between the age of 20-50 years, having buttock pain of ≥ 3 on NPRS since 3 months or more and a score of ≥ 8 on a 12-point clinical scoring system as well as any two of the positive screening tests will be recruited in this study as patients of piriformis syndrome.
These subjects will be selected via non-probability purposive sampling technique, followed by randomization into two groups using blocked randomization method.
A total of 6 treatment sessions will be given to each participant over the duration of 2 weeks with a total of 3 follow-ups after every 2 sessions.
TENS and hot pack followed by reciprocal inhibition technique will be given to the experimental group A, while the active comparator group B will be given TENS and hot pack followed by post-facilitation muscle energy technique.
Both the groups will be guided about the strengthening exercises given as a home plan.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nimrah Haq, MS-MSKPT*
- Phone Number: 0311-5445539
- Email: nimrahhaq254@gmail.com
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Recruiting
- Foundation University College of Physical Therapy
-
Contact:
- Ruqia Begum, MS-OMPT
- Phone Number: 03115532544
- Email: ruqia@fui.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age: 20-50 years
- Both Genders
- Chronic pain in buttock and hip area (≥ 3 on NPRS) lasting more than 3 months.
- Shortened piriformis muscle (Internal rotation less than 30°) on muscle length assessment.
- A score of ≥ 8 on a 12-point clinical scoring system.
- At least two positive screening tests.
Exclusion Criteria:
- Active infection
- Lower lumbar radiculopathy
- Sacroiliac joint dysfunction
- Malignancies
- History of trauma
- Hip Arthroplasty
- Rheumatoid/ Osteoarthritis
- Any neurological dysfunction
Study Plan
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: RI-MET group
RI-MET group A will receive 3-5 repetitions of reciprocal inhibition to the shortened piriformis muscle in supine and prone positions i.e. 30-50% isometric contraction of the muscle opposite to the muscle to be stretched for 7-10 seconds, followed by inhalation, exhalation and rest period of 5 seconds and then a stretch (through the new barrier with patients' assistance) of 10-60 seconds hold.both groups will receive conventional physical therapy which they will be taught as a home plan. Following exercises are guided to the patient as home plan.
|
Reciprocal Inhibition MET will be applied to the shortened piriformis muscle in supine and prone positions with participants using 30-50% of their maximum voluntary isometric contraction.
It will include 30-50% isometric contraction of the muscle opposite to the muscle to be stretched for 7-10 seconds, followed by inhalation, exhalation and rest period of 5 seconds and then a stretch (through the new barrier with patients' assistance) of 10-60 seconds hold.
RI-MET group will receive 3-5 repetitions.
TENS and hot pack application to provide heating effect over the painful area (10 minutes) Both groups will receive conventional physical therapy which they will be taught as a home plan. Following exercises are guided to the patient as home plan.
|
|
Experimental: PFS-MET group
PFS-MET group will receive 3-5 repetitions of post-facilitation stretch to the shortened piriformis muscle in supine and prone positions i.e. 20% maximal isometric contraction of the muscle to be stretched for 6-10 seconds, followed by a rapid stretch (through the new barrier) of 15 seconds hold. After stretch, the muscle is allowed to relax in the midrange for up to 30 seconds.Both groups will receive conventional physical therapy which they will be taught as a home plan. Following exercises are guided to the patient as home plan.
|
TENS and hot pack application to provide heating effect over the painful area (10 minutes) Both groups will receive conventional physical therapy which they will be taught as a home plan. Following exercises are guided to the patient as home plan.
Post-facilitation stretch technique for shortened piriformis muscle in supine and prone positions will be applied with participants using 20% of their maximum voluntary isometric contraction.
It will include 20% maximal isometric contraction of the muscle to be stretched for 6-10 seconds, followed by a rapid stretch (through the new barrier) of 15 seconds hold.
After stretch, the muscle is allowed to relax in the midrange for up to 30 seconds.
PFS-MET group will receive 3-5 repetitions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 2 weeks
|
The pre and post pain intensity will be measured using Numeric Pain Rating Scale (NPRS) comprising of 11 points from 0 - 10 where 0 indicates "no pain" while 10 is "maximally felt pain".
|
2 weeks
|
|
Hip range of motion
Time Frame: 2 weeks
|
Goniometer will be used to measure the pre and post treatment ranges of internal rotation, external rotation, abduction and adduction at hip joint in supine and sitting positions.
|
2 weeks
|
|
Functional Disability
Time Frame: 2 weeks
|
Lower Extremity Functional Scale comprising of 20 questions regarding lower extremity function will be used.
The maximum possible score is 80 points, indicating very high function.
The minimum possible score is 0 points, indicating very low function.
|
2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
Other Study ID Numbers
- FUI/CTR/2024/21
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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