NCT05404607

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

June 3, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

May 31, 2022

Last Update Submit

May 31, 2022

Conditions

Keywords

integrated neuromuscular inhibition techniquemuscle energy techniquepiriformis syndromepositional release techniquefascial distortion model

Outcome Measures

Primary Outcomes (4)

  • 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).

    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.

    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.

    6th week

  • Goniometer for range of motion

    It is a tool used to measure range of motions of different joints

    6th week

Study Arms (2)

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.

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.

Other: Fascial distortion method

Interventions

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 method with neuromuscular inhibition technique

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.

Fascial distortion method

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GOVT Eye Cum General Hospital Gojra (THQ)

Gojra, Punjab Province, 56000, Pakistan

Location

Related Publications (12)

  • 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.

    PMID: 34049428BACKGROUND
  • 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.

    PMID: 28836092BACKGROUND
  • 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).

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 29184293BACKGROUND
  • 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.

    PMID: 33145535BACKGROUND
  • 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.

    PMID: 27935076BACKGROUND
  • 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.

    PMID: 28567214BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32922937BACKGROUND
  • 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).

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Piriformis Muscle Syndrome

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Study Officials

  • Muhammad Salman Bashir, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 3, 2022

Study Start

June 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

June 3, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations