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Effects of Fascial Distortion Model With and Without Neuromuscular Inhibition in Patients With Piriformis Syndrome

Primary Purpose

Piriformis Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Fascial distortion method with neuromuscular inhibition technique
Fascial distortion method
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Piriformis Syndrome focused on measuring integrated neuromuscular inhibition technique, muscle energy technique, piriformis syndrome, positional release technique, fascial distortion model

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • GOVT Eye Cum General Hospital Gojra (THQ)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fascial distortion method with neuromuscular inhibition technique

Fascial distortion method

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.
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.
Goniometer for range of motion
It is a tool used to measure range of motions of different joints

Secondary Outcome Measures

Full Information

First Posted
May 31, 2022
Last Updated
May 31, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05404607
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Piriformis Syndrome
Keywords
integrated neuromuscular inhibition technique, muscle energy technique, piriformis syndrome, positional release technique, fascial distortion model

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fascial distortion method with neuromuscular inhibition technique
Arm Type
Experimental
Arm Description
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.
Arm Title
Fascial distortion method
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fascial distortion method with neuromuscular inhibition technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Fascial distortion method
Intervention Description
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.
Primary Outcome Measure Information:
Title
NPRS for pain
Description
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).
Time Frame
6th week
Title
Sciatica bothersomeness Index for sciatica
Description
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.
Time Frame
6th week
Title
Short Form Health Survey (SF-36) questionnaire for quality of life
Description
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.
Time Frame
6th week
Title
Goniometer for range of motion
Description
It is a tool used to measure range of motions of different joints
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
GOVT Eye Cum General Hospital Gojra (THQ)
City
Gojra
State/Province
Punjab
ZIP/Postal Code
56000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Phone
+923334497959
Email
salman.bashir@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Zainab Aroob, MSPT-OM

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34049428
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.
Results Reference
background
PubMed Identifier
28836092
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.
Results Reference
background
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).
Results Reference
background
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.
Results Reference
background
PubMed Identifier
29184293
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.
Results Reference
background
PubMed Identifier
33145535
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.
Results Reference
background
PubMed Identifier
27935076
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.
Results Reference
background
PubMed Identifier
28567214
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
32922937
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.
Results Reference
background
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).
Results Reference
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Effects of Fascial Distortion Model With and Without Neuromuscular Inhibition in Patients With Piriformis Syndrome

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