Clinical trial NCT05404607: Effects of Fascial Distortion Model With and Without Neuromuscular Inhibition in Patients With Piriformis Syndrome
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Piriformis Syndrome
Keywords: integrated neuromuscular inhibition technique
muscle energy technique
piriformis syndrome
positional release technique
fascial distortion model
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: NPRS for pain
timeFrame: 6th week
measure: Sciatica bothersomeness Index for sciatica
timeFrame: 6th week
measure: Short Form Health Survey (SF-36) questionnaire for quality of life
timeFrame: 6th week
measure: Goniometer for range of motion
timeFrame: 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Gojra
country: Pakistan
facility: GOVT Eye Cum General Hospital Gojra (THQ)
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Salman Bashir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hopayian 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.
citation: 9. 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).
citation: 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.
citation: 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.
citation: Aquino-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.
citation: Fishman 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.
citation: Han 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.
citation: 16. 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.
citation: 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.
citation: 18. 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).