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Effects of Hold Relax With Agonist Contraction and Active Release Therapy on Clinical Outcomes in Piriformis Syndrome

Primary Purpose

Piriformis Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Hold Relax with Agonist Contraction
Active Release Therapy
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Piriformis Syndrome focused on measuring Function, Pain,Hold Relax ,Sleep Quality, Mobilization

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age group 25-55 years
  2. Both male and female.
  3. Gluteal pain with or without radicular symptoms.
  4. Patients of piriformis syndrome diagnosed by orthopedic consultant.
  5. Sub-acute and chronic piriformis syndrome.
  6. Unilateral pain.
  7. Pain score equal to and greater than 3 according to pain rating scale.

Exclusion Criteria:

  1. Intermittent vascular claudication and spondylolisthesis.
  2. Past history of hip, femur or vertebral fracture
  3. Past history of spinal surgery.
  4. Spinal tuberculosis.
  5. Rheumatoid disease.
  6. Disc pathology, sacroiliac joint dysfunction or mechanical back pain.
  7. History of infectious disease.
  8. Leg length discrepancy.
  9. Any postural abnormality or deformity.

Sites / Locations

  • The University of Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

This group of participants will receive Hold Relax with Agonist Contraction (HR-AC) technique with routine physical therapy. The protocol will be given to the participants for two weeks (6 sessions on alternate days, 3 session per week). Each session will be of 60 minutes. The data will be collected before applying intervention, at first week and at 2nd week.

This group of participants will receive Active Release Therapy, a kind of soft tissue mobilization along with routine physical therapy. The protocol will be given to the participants for two weeks (6 sessions on alternate days, 3 session per week). Each session will be of 60 minutes. The data will be collected before applying intervention, at first week and at 2nd week.

Outcomes

Primary Outcome Measures

Change in Pain Intensity
Numeric Pain Rating Scale will be used to measure the intensity of pain
Change in Functional Disability
Ronald-Morris Disability Questionnaire will be used to a assess the level of disability
Sleep Quality
Chronic Pain Sleep Inventory will be used to to assess the quality of sleep on a 100 mm VAS scale

Secondary Outcome Measures

Full Information

First Posted
May 6, 2022
Last Updated
April 5, 2023
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05370378
Brief Title
Effects of Hold Relax With Agonist Contraction and Active Release Therapy on Clinical Outcomes in Piriformis Syndrome
Official Title
Comparative Effects of Hold Relax With Agonist Contraction and Active Release Therapy on Pain, Functional Disability and Sleep Quality in Piriformis Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
November 22, 2022 (Actual)
Study Completion Date
November 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore

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 this study is to compare the effects of hold relax agonist contraction and active release therapy on reducing pain intensity, improving functioning and sleep quality in patient with piriformis syndrome. Both these techniques are passive, non-invasive manual therapy techniques which are easy to perform and less time consuming and may yield better outcomes resulting improved quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Piriformis Syndrome
Keywords
Function, Pain,Hold Relax ,Sleep Quality, Mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A: Hold Relax with Agonist Contraction with Routine Physical Therapy Group B: Active Release Therapy with Routine Physical Therapy
Masking
Outcomes Assessor
Masking Description
Opaque Sealed Envelops will be provided to participants by investigator, with mentioned treatment group. A separate therapist serving as outcome assessor will be unaware of treatment group provided.
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
This group of participants will receive Hold Relax with Agonist Contraction (HR-AC) technique with routine physical therapy. The protocol will be given to the participants for two weeks (6 sessions on alternate days, 3 session per week). Each session will be of 60 minutes. The data will be collected before applying intervention, at first week and at 2nd week.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
This group of participants will receive Active Release Therapy, a kind of soft tissue mobilization along with routine physical therapy. The protocol will be given to the participants for two weeks (6 sessions on alternate days, 3 session per week). Each session will be of 60 minutes. The data will be collected before applying intervention, at first week and at 2nd week.
Intervention Type
Other
Intervention Name(s)
Hold Relax with Agonist Contraction
Other Intervention Name(s)
Proprioceptive Neuromuscular Facilitation Technique
Intervention Description
Participant will be in prone lying and heating pad will be applied on gluteal region for 10 to 15 minutes. Passive sustained stretch to piriformis will be applied for 10 seconds. The participant will be asked to actively contract the muscle for about 10 seconds (isometric contraction) and then relax. Immediately after that participant is ask to again actively contract the muscle against therapist resistance for 6-10 seconds. Ask the participant to relax while therapist will apply stretch the muscle to its new tissue tension barrier position and this position will be maintained for 30 seconds. This maneuver is repeated for 3 to 4 repetitions, each starting from where the previous finished.
Intervention Type
Other
Intervention Name(s)
Active Release Therapy
Other Intervention Name(s)
Soft Tissue Mobilization
Intervention Description
Specific muscle will be warmed up by applying heating pad for 10 to 15 minutes. Patient will be positioned prone lying and the therapist will be standing at the side of affected limb. Therapist will apply deep pressure at the area of tenderness while patient will actively move the limb from internal to external rotation repeatedly. This maneuver will take about 15 minutes to complete in one session and will be applied alternatively 3 days a week for two weeks. After this, cold pack is applied and general ROMs and strengthening exercises are performed to prevent soreness
Primary Outcome Measure Information:
Title
Change in Pain Intensity
Description
Numeric Pain Rating Scale will be used to measure the intensity of pain
Time Frame
Pain score will be measured at the baseline, at end of first session and at 6th session on 2nd week
Title
Change in Functional Disability
Description
Ronald-Morris Disability Questionnaire will be used to a assess the level of disability
Time Frame
Change in functional status will be measured at the baseline, at end of first session and at end of 6th session
Title
Sleep Quality
Description
Chronic Pain Sleep Inventory will be used to to assess the quality of sleep on a 100 mm VAS scale
Time Frame
Sleep quality will be measured at the baseline, at end of first session and at end of 6th session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age group 25-55 years Both male and female. Gluteal pain with or without radicular symptoms. Patients of piriformis syndrome diagnosed by orthopedic consultant. Sub-acute and chronic piriformis syndrome. Unilateral pain. Pain score equal to and greater than 3 according to pain rating scale. Exclusion Criteria: Intermittent vascular claudication and spondylolisthesis. Past history of hip, femur or vertebral fracture Past history of spinal surgery. Spinal tuberculosis. Rheumatoid disease. Disc pathology, sacroiliac joint dysfunction or mechanical back pain. History of infectious disease. Leg length discrepancy. Any postural abnormality or deformity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Jamil, M.Phil
Organizational Affiliation
The University of Lahore
Official's Role
Study Chair
Facility Information:
Facility Name
The University of Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlies the results reported in article after deidentification
IPD Sharing Time Frame
Immediately following publication. Ending in 36 months.

Learn more about this trial

Effects of Hold Relax With Agonist Contraction and Active Release Therapy on Clinical Outcomes in Piriformis Syndrome

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