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

May 31, 2022 updated by: Riphah International University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Gojra, Punjab, Pakistan, 56000
        • GOVT Eye Cum General Hospital Gojra (THQ)
        • Contact:
        • Principal Investigator:
          • Zainab Aroob, MSPT-OM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fascial distortion method with neuromuscular inhibition technique
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
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.
Active Comparator: Fascial distortion method
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6th week
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.
6th week
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.
6th week
Goniometer for range of motion
Time Frame: 6th week
It is a tool used to measure range of motions of different joints
6th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Muhammad Salman Bashir, PhD, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Actual)

June 3, 2022

Last Update Submitted That Met QC Criteria

May 31, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/22/0120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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