Piriformis SyndromeNCT05404607
Effects of Fascial Distortion Model With and Without Neuromuscular Inhibition in Patients With Piriformis Syndrome
A study testing Fascial distortion method with neuromuscular inhibition technique and Fascial distortion method in people with Piriformis Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of study will be to find the effects of fascial distortion model (FDM) with and without the Integrated neuromuscular inhibition technique (INIT) in piriformis syndrome. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Piriformis Syndrome
- What is being tested?
- Fascial distortion method with neuromuscular inhibition technique and Fascial distortion method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2022to 1 Jan 2023
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral buttock pain and radiculopathy due to spasms of the piriformis muscle or sciatic nerve compression.
- Aggravate buttock pain in sitting and limited SLR.
- Patient with Freiberg test positive.
- Patient with FAIR test positive.
- Patient with positive Pace test.
- Patient with positive Beatty's maneuver.
Who cannot join
- Lumbar spinal pathology and recent injury around the hip, sacroiliac joint, or lumbar spine.
- Patient with a positive Faber test
- SIJ Pathology like SIJ dysfunction, innominate anterior or posterior rotation dysfunction, etc.
- Deep gluteal syndrome.
- Recent surgery like hip arthroplasty, surgical emplacement of a gluteal implant (buttock prosthesis); lip sculpture (fat transfer and liposuction); and body contouring (surgery and lip sculpture).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
GOVT Eye Cum General Hospital Gojra (THQ)
Gojra, Punjab Province, 56000
Muhammad Salman Bashir, PhD, +923334497959, salman.bashir@riphah.edu.pk
Zainab Aroob, MSPT-OM
About this study
Official title: Comparative Effects of Fascial Distortion Model With and Without Neuromuscular Inhibition Technique on Pain, Range of Motion and Quality of Life in Patients With Piriformis Syndrome
The aim of study will be to find the effects of fascial distortion model (FDM) with and without the Integrated neuromuscular inhibition technique (INIT) in piriformis syndrome.
Read the detailed description
Piriformis syndrome is a misdiagnosed cause of sciatica leg or buttock pain and disability. The male and female incidence ratio of PS is 6.1. The fascial distortion model is a targeted manual technique and decodes categorized manual gestures (pain-related body language) to 6 pathophysiological mechanisms involved in the etiology of pain. Integrated neuromuscular inhibition technique(INIT) is a combination of muscle energy technique(MET) and positional release technique(PRT).
All previous studies in which integrated neuromuscular inhibition technique(INIT) and fascial distortion model(FDM) has been performed on different muscles of the body has shown greater improvement as compared to other techniques. Comparative effects of fascial distortion model with integrated neuromuscular inhibition technique and fascial distortion model on Piriformis Syndrome has not been addressed yet. There is very limited data available on this protocol. Therefore, this study aims to compare the effects of facial distortion model with and without integrated neuromuscular inhibition technique.
- Conditions
- Piriformis Syndrome
- Being tested
- Fascial distortion method with neuromuscular inhibition technique, Fascial distortion method
- Keywords
- integrated neuromuscular inhibition technique, muscle energy technique, piriformis syndrome, positional release technique, fascial distortion model
- 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.
Fascial distortion method with neuromuscular inhibition techniqueOther
27 participants will receive FDM with INIT followed by neural mobilization for a total of 20 to 30 minutes, 3 times per week on alternate days for 6 weeks.
Fascial distortion methodOther
27 participants will receive FDM followed by neural mobilization for a total of 20 to 30 minutes, 3 times per week on alternate days for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fascial distortion method with neuromuscular inhibition technique | Experimental | 27 participants will receive the fascial distortion method followed by the neuromuscular inhibition technique for trigger points. After this, neural mobilization will be given as stander treatment. Receives: Other: Fascial distortion method with neuromuscular inhibition technique |
| Fascial distortion method | Active comparator | Fascial distortion will be applied to 27 participants where the tip of the thumb worms its way through the peripheral tissue until it rests on the distortion. Force is focused directly on the most painful spot until the provider feels like a button-slipping-into-a-buttonhole. After this, neural mobilization will be given as a stander treatment. Receives: Other: Fascial distortion method |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS for pain
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: 6th week
Sciatica bothersomeness Index for sciatica
It is a composite score of four questions (each score ranging from 0-6) that include elements of leg pain and sensory and motor disturbances.
Measured: 6th week
Short Form Health Survey (SF-36) questionnaire for quality of life
It is used to indicate the health status of particular populations, to help with service planning and to measure the impact of clinical and social interventions.
Measured: 6th week
Goniometer for range of motion
It is a tool used to measure range of motions of different joints
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study startJun 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Piriformis SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Salman Bashir, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404607
- Sponsor's protocol ID
- REC/RCR & AHS/22/0120
- Status last verified
- May 2022
- First submitted
- 31 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Danazumi MS, Yakasai AM, Ibrahim AA, Shehu UT, Ibrahim SU. Effect of integrated neuromuscular inhibition technique compared with positional release technique in the management of piriformis syndrome. J Osteopath Med. 2021 May 31;121(8):693-703. doi: 10.1515/jom-2020-0327.
PubMed 34049428Hopayian K, Danielyan A. Four symptoms define the piriformis syndrome: an updated systematic review of its clinical features. Eur J Orthop Surg Traumatol. 2018 Feb;28(2):155-164. doi: 10.1007/s00590-017-2031-8. Epub 2017 Aug 23.
PubMed 288360929. Ahmed MAA. Dexamethasone Magnesium Sulfate as an Adjuvant to Local Anesthetics in the Ultra-Sound Guided Injection of Piriformis Muscle for the Treatment of Piriformis Syndrome. The Open Anesthesia Journal. 2020;14(1).
10. Bose G, Dusad G. Effect of reciprocal inhibition and post isometric relaxation; types of muscle energy technique in piriformis syndrome-a comparative study. EJPMR; 2018.
Park JC, Shim JH, Chung SH. The effects of three types of piriform muscle stretching on muscle thickness and the medial rotation angle of the coxal articulation. J Phys Ther Sci. 2017 Oct;29(10):1811-1814. doi: 10.1589/jpts.29.1811. Epub 2017 Oct 21.
PubMed 29184293Aquino-Jose VM, Blinder V, Johnson J, Havryliuk T. Ultrasound-guided trigger point injection for piriformis syndrome in the emergency department. J Am Coll Emerg Physicians Open. 2020 Jun 24;1(5):876-879. doi: 10.1002/emp2.12153. eCollection 2020 Oct.
PubMed 33145535Fishman LM, Wilkins AN, Rosner B. Electrophysiologically identified piriformis syndrome is successfully treated with incobotulinum toxin a and physical therapy. Muscle Nerve. 2017 Aug;56(2):258-263. doi: 10.1002/mus.25504. Epub 2017 Apr 2.
PubMed 27935076Han SK, Kim YS, Kim TH, Kang SH. Surgical Treatment of Piriformis Syndrome. Clin Orthop Surg. 2017 Jun;9(2):136-144. doi: 10.4055/cios.2017.9.2.136. Epub 2017 May 8.
PubMed 2856721416. Kale A, Basol G, Kuru B, Gundogdu E, Mat E, Yildiz G, et al. Laparoscopic Surgical Approach for the Treatment of Pelvic Piriformis Syndrome. Authorea Preprints. 2020.
Hogan E, Vora D, Sherman JH. A minimally invasive surgical approach for the treatment of piriformis syndrome: a case series. Chin Neurosurg J. 2020 Mar 30;6:8. doi: 10.1186/s41016-020-00189-y. eCollection 2020.
PubMed 3292293718. Danazumi MS, Yakasai AM, Ibrahim SU. Effect of integrated neuromuscular inhibition technique in the management of piriformis syndrome: a case report. Middle East Journal of Rehabilitation and Health Studies. 2020;7(2).
Aroob Z, Bashir MS, Noor R, Ikram M, Ramzan F, Naseer A, Sabir N. Comparative effects of fascial distortion model with and without neuromuscular inhibition technique on pain, range of motion and quality of life in patients with piriformis syndrome. Disabil Rehabil. 2025 May;47(9):2378-2383. doi: 10.1080/09638288.2024.2395456. Epub 2024 Sep 3.
PubMed 39224057
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Fascial Distortion Model With and Without Neuromuscular Inhibition Technique on Pain, Range of Motion and Quality of Life in Patients With Piriformis Syndrome
- ClinicalTrials.gov ID
- NCT05404607
- Acronym / sponsor ID
- REC/RCR & AHS/22/0120
- Conditions
- Piriformis Syndrome
- Keywords
- integrated neuromuscular inhibition technique, muscle energy technique, piriformis syndrome, positional release technique, fascial distortion model
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 3 Jun 2022 (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.
The aim of study will be to find the effects of fascial distortion model (FDM) with and without the Integrated neuromuscular inhibition technique (INIT) in piriformis syndrome.
Detailed description
Piriformis syndrome is a misdiagnosed cause of sciatica leg or buttock pain and disability. The male and female incidence ratio of PS is 6.1. The fascial distortion model is a targeted manual technique and decodes categorized manual gestures (pain-related body language) to 6 pathophysiological mechanisms involved in the etiology of pain. Integrated neuromuscular inhibition technique(INIT) is a combination of muscle energy technique(MET) and positional release technique(PRT).
All previous studies in which integrated neuromuscular inhibition technique(INIT) and fascial distortion model(FDM) has been performed on different muscles of the body has shown greater improvement as compared to other techniques. Comparative effects of fascial distortion model with integrated neuromuscular inhibition technique and fascial distortion model on Piriformis Syndrome has not been addressed yet. There is very limited data available on this protocol. Therefore, this study aims to compare the effects of facial distortion model with and without integrated neuromuscular inhibition technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascial distortion method with neuromuscular inhibition technique | Experimental | Other: Fascial distortion method with neuromuscular inhibition technique27 participants will receive the fascial distortion method followed by the neuromuscular inhibition technique for trigger points. After this, neural mobilization will be given as stander treatment. |
| Fascial distortion method | Active comparator | Other: Fascial distortion methodFascial distortion will be applied to 27 participants where the tip of the thumb worms its way through the peripheral tissue until it rests on the distortion. Force is focused directly on the most painful spot until the provider feels like a button-slipping-into-a-buttonhole. After this, neural mobilization will be given as a stander treatment. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Unilateral buttock pain and radiculopathy due to spasms of the piriformis muscle or sciatic nerve compression.
- Aggravate buttock pain in sitting and limited SLR.
- Patient with Freiberg test positive.
- Patient with FAIR test positive.
- Patient with positive Pace test.
Key exclusion criteria (5 listed)
- Lumbar spinal pathology and recent injury around the hip, sacroiliac joint, or lumbar spine.
- Patient with a positive Faber test
- SIJ Pathology like SIJ dysfunction, innominate anterior or posterior rotation dysfunction, etc.
- Deep gluteal syndrome.
- Recent surgery like hip arthroplasty, surgical emplacement of a gluteal implant (buttock prosthesis); lip sculpture (fat transfer and liposuction); and body contouring (surgery and lip sculpture).
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 |
|---|---|---|
| Fascial distortion method with neuromuscular inhibition technique27 participants will receive FDM with INIT followed by neural mobilization for a total of 20 to 30 minutes, 3 times per week on alternate days for 6 weeks. | Other | Fascial distortion method with neuromuscular inhibition technique |
| Fascial distortion method27 participants will receive FDM followed by neural mobilization for a total of 20 to 30 minutes, 3 times per week on alternate days for 6 weeks. | Other | Fascial distortion method |
Primary outcome
NPRS for pain
Time frame: 6th week
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Sciatica bothersomeness Index for sciatica
Time frame: 6th week
It is a composite score of four questions (each score ranging from 0-6) that include elements of leg pain and sensory and motor disturbances.
Short Form Health Survey (SF-36) questionnaire for quality of life
Time frame: 6th week
It is used to indicate the health status of particular populations, to help with service planning and to measure the impact of clinical and social interventions.
Goniometer for range of motion
Time frame: 6th week
It is a tool used to measure range of motions of different joints
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Background: PubMed 34049428Danazumi MS, Yakasai AM, Ibrahim AA, Shehu UT, Ibrahim SU. Effect of integrated neuromuscular inhibition technique compared with positional release technique in the management of piriformis syndrome. J Osteopath Med. 2021 May 31;121(8):693-703. doi: 10.1515/jom-2020-0327.
- Background: PubMed 28836092Hopayian K, Danielyan A. Four symptoms define the piriformis syndrome: an updated systematic review of its clinical features. Eur J Orthop Surg Traumatol. 2018 Feb;28(2):155-164. doi: 10.1007/s00590-017-2031-8. Epub 2017 Aug 23.
- Background9. Ahmed MAA. Dexamethasone Magnesium Sulfate as an Adjuvant to Local Anesthetics in the Ultra-Sound Guided Injection of Piriformis Muscle for the Treatment of Piriformis Syndrome. The Open Anesthesia Journal. 2020;14(1).
- Background10. Bose G, Dusad G. Effect of reciprocal inhibition and post isometric relaxation; types of muscle energy technique in piriformis syndrome-a comparative study. EJPMR; 2018.
- Background: PubMed 29184293Park JC, Shim JH, Chung SH. The effects of three types of piriform muscle stretching on muscle thickness and the medial rotation angle of the coxal articulation. J Phys Ther Sci. 2017 Oct;29(10):1811-1814. doi: 10.1589/jpts.29.1811. Epub 2017 Oct 21.
- Background: PubMed 33145535Aquino-Jose VM, Blinder V, Johnson J, Havryliuk T. Ultrasound-guided trigger point injection for piriformis syndrome in the emergency department. J Am Coll Emerg Physicians Open. 2020 Jun 24;1(5):876-879. doi: 10.1002/emp2.12153. eCollection 2020 Oct.
- Background: PubMed 27935076Fishman LM, Wilkins AN, Rosner B. Electrophysiologically identified piriformis syndrome is successfully treated with incobotulinum toxin a and physical therapy. Muscle Nerve. 2017 Aug;56(2):258-263. doi: 10.1002/mus.25504. Epub 2017 Apr 2.
- Background: PubMed 28567214Han SK, Kim YS, Kim TH, Kang SH. Surgical Treatment of Piriformis Syndrome. Clin Orthop Surg. 2017 Jun;9(2):136-144. doi: 10.4055/cios.2017.9.2.136. Epub 2017 May 8.
- Background16. Kale A, Basol G, Kuru B, Gundogdu E, Mat E, Yildiz G, et al. Laparoscopic Surgical Approach for the Treatment of Pelvic Piriformis Syndrome. Authorea Preprints. 2020.
- Background: PubMed 32922937Hogan E, Vora D, Sherman JH. A minimally invasive surgical approach for the treatment of piriformis syndrome: a case series. Chin Neurosurg J. 2020 Mar 30;6:8. doi: 10.1186/s41016-020-00189-y. eCollection 2020.
- Background18. Danazumi MS, Yakasai AM, Ibrahim SU. Effect of integrated neuromuscular inhibition technique in the management of piriformis syndrome: a case report. Middle East Journal of Rehabilitation and Health Studies. 2020;7(2).
- Derived from this study: PubMed 39224057Aroob Z, Bashir MS, Noor R, Ikram M, Ramzan F, Naseer A, Sabir N. Comparative effects of fascial distortion model with and without neuromuscular inhibition technique on pain, range of motion and quality of life in patients with piriformis syndrome. Disabil Rehabil. 2025 May;47(9):2378-2383. doi: 10.1080/09638288.2024.2395456. Epub 2024 Sep 3.
- Individual participant dataSharing planned: No
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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.
Muhammad Salman Bashir, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial distortion method with neuromuscular inhibition technique and Fascial distortion method in people with Piriformis Syndrome, run by Riphah International University 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 5 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 3 Jun 2022. 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 Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPRS for pain (time frame: 6th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05404607, which also lists 12 linked publications.
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 3 Jun 2022.