Piriformis SyndromeNCT06534788
Effects of Reciprocal Inhibition Versus Post Facilitation Muscle Energy Technique Along With Conventional Physical Therapy in Patients With Piriformis Syndrome: a Randomized Controlled Trial
A study testing Reciprocal Inhibition MET, Post-facilitation MET and Conventional physical therapy in people with Piriformis Syndrome, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This study is a randomized controlled trial and the purpose of this study is to compare the effects of reciprocal inhibition versus post facilitation muscle energy technique along with conventional physical therapy in patients with piriformis syndrome in terms of pain, range of motion at hip joint and functional… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Piriformis Syndrome
- What is being tested?
- Reciprocal Inhibition MET, Post-facilitation MET and Conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 31 May 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Active infection
- Lower lumbar radiculopathy
- Sacroiliac joint dysfunction
- Malignancies
- History of trauma
- Hip Arthroplasty
- Rheumatoid/ Osteoarthritis
- Any neurological dysfunction
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Ruqia Begum, MS-OMPT, 03115532544, ruqia@fui.edu.pk
About this study
This study is a randomized controlled trial and the purpose of this study is to compare the effects of reciprocal inhibition versus post facilitation muscle energy technique along with conventional physical therapy in patients with piriformis syndrome in terms of pain, range of motion at hip joint and functional disability.
Read the 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.
- Conditions
- Piriformis Syndrome
- Being tested
- Reciprocal Inhibition MET, Post-facilitation MET, Conventional physical therapy
- Medical subject headings
- Piriformis Muscle Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reciprocal Inhibition METOther
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.
Post-facilitation METOther
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.
Conventional physical therapyOther
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.
- Resisted abduction with Thera/resistance band
- Resisted bridging with Thera/resistance band
- Resisted clam exercise with Thera/resistance band
| Study group | Role | What they receive |
|---|---|---|
| RI-MET group | Experimental | 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.
* Resisted abduction with Thera/resistance band
* Resisted bridging with Thera/resistance band
* Resisted clam exercise with Thera/resistance band Receives: Other: Reciprocal Inhibition MET; Other: Conventional physical therapy |
| PFS-MET group | Experimental | 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.
* Resisted abduction with Thera/resistance band
* Resisted bridging with Thera/resistance band
* Resisted clam exercise with Thera/resistance band Receives: Other: Post-facilitation MET; Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
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".
Measured: 2 weeks
Hip range of motion
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.
Measured: 2 weeks
Functional Disability
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start31 May 2024
- Primary completion15 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Piriformis SyndromeStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534788
- Sponsor's protocol ID
- FUI/CTR/2024/21
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Reciprocal Inhibition Versus Post Facilitation Muscle Energy Technique Along With Conventional Physical Therapy in Patients With Piriformis Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06534788
- Acronym / sponsor ID
- FUI/CTR/2024/21
- Conditions
- Piriformis Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled trial and the purpose of this study is to compare the effects of reciprocal inhibition versus post facilitation muscle energy technique along with conventional physical therapy in patients with piriformis syndrome in terms of pain, range of motion at hip joint and functional disability.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| RI-MET group | Experimental | Other: Reciprocal Inhibition MET, Other: Conventional physical therapyRI-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. * Resisted abduction with Thera/resistance band * Resisted bridging with Thera/resistance band * Resisted clam exercise with Thera/resistance band |
| PFS-MET group | Experimental | Other: Post-facilitation MET, Other: Conventional physical therapyPFS-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. * Resisted abduction with Thera/resistance band * Resisted bridging with Thera/resistance band * Resisted clam exercise with Thera/resistance band |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Active infection
- Lower lumbar radiculopathy
- Sacroiliac joint dysfunction
- Malignancies
- History of trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reciprocal Inhibition METReciprocal 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. | Other | RI-MET group |
| Post-facilitation METPost-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. | Other | PFS-MET group |
| Conventional physical therapyTENS 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. * Resisted abduction with Thera/resistance band * Resisted bridging with Thera/resistance band * Resisted clam exercise with Thera/resistance band | Other | PFS-MET group, RI-MET group |
Primary outcome
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".
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
Related trials for Piriformis Syndrome
Not yet recruitingPhase 2
Efficacy of Botulinum Toxin Versus Placebo on Pain and Health Related Quality of Life of Patients With Piriformis Muscle Syndrome
Piriformis Muscle Syndrome
Recruiting
Interfascial Hydrodissection Added to Ultrasound-Guided Piriformis Injection for Piriformis Syndrome
Piriformis Syndrome
Recruiting
Comparative Effects of Post-Isometric Relaxation and Reciprocal Inhibition Techniques inPiriformis Syndrome
Piriformis Syndrome
Enrolling by invitation
Neural Gliders With and Without ESWT for Deep Gluteal Syndrome
Deep Gluteal Syndrome
Enrolling by invitation
Comparative Effects of the Bowen Technique With and Without Extracorporeal Shock Wave Therapy in Patients With Deep Gluteal Syndrome
Deep Gluteal Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reciprocal Inhibition MET, Post-facilitation MET and Conventional physical therapy in people with Piriformis Syndrome, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nimrah Haq, MS-MSKPT* (0311-5445539, nimrahhaq254@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.