Comparative Effect of Active Release Technique Versus Self-myofascial Release in Improving Piriformis Syndrome
Primary Purpose
Piriformis Syndrome
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Active release technique
Self-myofascial release
Sponsored by
About this trial
This is an interventional treatment trial for Piriformis Syndrome
Eligibility Criteria
Inclusion Criteria: 20-40 years males and females Pain more than 1 month. Piriformis syndrome diagnosed through screening tests (FAIR test, Beatty test, Freiberg test, Sign of Pace) A score ≥8 on a 12-point Clinical scoring system for diagnosis of piriformis syndrome Exclusion Criteria: Inflammation, malignancy, arthritis, active infection, post-partum or pregnant females and post-op patients, any deformity. Leg pain due to causes other than piriformis syndrome Any traumatic History.
Sites / Locations
- Sehat Medical Complex, Lahore
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Group A
Group B
Arm Description
Group A received Active release technique (ART)
Group B received self-myofascial release (SMFR)
Outcomes
Primary Outcome Measures
Likert pain scale (change is being assessed)
Pain intensity is principally assessed using rating scales such as the 11-point Likert scale. In general, frequent pain assessments are serially correlated and underdispersed. The aim of this investigation was to develop population models adapted to fit the 11-point pain scale.
Lower extremity functional scale (change is being assessed)
The lower extremity functional scale (LEFS) is a valid patient-rated outcome measure (PROM) for the measurement of lower extremity function.
The maximum possible score is 80 points, indicating very high function. The minimum possible score is 0 points, indicating very low function.
Range of Motion by Goniometer (change is being assessed)
Range of straight leg raise (SLR) and Internal rotation range would be measured
Secondary Outcome Measures
Full Information
NCT ID
NCT05742633
First Posted
February 15, 2023
Last Updated
August 31, 2023
Sponsor
Sehat Medical Complex
1. Study Identification
Unique Protocol Identification Number
NCT05742633
Brief Title
Comparative Effect of Active Release Technique Versus Self-myofascial Release in Improving Piriformis Syndrome
Official Title
Comparative Effect of Active Release Technique Versus Self-myofascial Release in Improving Piriformis Syndrome. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sehat Medical Complex
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this Randomized controlled trial is to examine comparative effect of active release technique versus self-myofascial release in improving piriformis syndrome. The main question it aims to answer is:
• To compare the effects of Active release technique (ART) and Self-Myofascial release (SMFR) on pain intensity, hip internal rotation and functional disability in patients with piriformis syndrome.
Participants will be a given consent form and after subjects read and sign the informed consent, they would be included in study according to eligibility criteria. 2 groups would be included in study, Active release technique will be applied on group A by the physiotherapist and self-myofascial release will be applied on group B by the patients themselves through the use of foam-rollers and massage ball to compare the results of both these techniques on reducing pain, improving range and functional disability among individuals with piriformis syndrome. We will measure outcome through different outcome measure tools.
Detailed Description
Piriformis is a key internal rotator of the hip which develops muscular imbalance due to overuse and pressure. There are various disabling conditions caused due to a simple tightness of Piriformis muscle like low back pain, sciatic nerve pain through muscle hypertrophy or a nearby anomaly due to its anatomically closeness to the sciatic nerve, pain and aesthesia in hip, thigh, calf and foot are symptoms that commonly occur in Piriformis syndrome. Piriformis syndrome is defined as a peripheral neuritis of the branches of the sciatic nerve caused by an abnormal condition of the piriformis muscle (PM), such as an injured or irritated muscle.
MFR technique involves application of a low load-long duration stretch to the myofascial complex which intends to restore the optimal length, decrease pain and improve functional mobility of the muscle. A special technique within MFR is self-myofascial release (SMFR), performed by the patient independently, instead of by a therapist. This technique utilizes the patient's body mass and special tools such as massage balls or foam rollers to apply pressure and stretch the restricted soft tissue. Active Release Techniques (ART) are a soft tissue method that focuses on relieving tissue tension via the removal of fibrosis/adhesions which can develop in tissues as a result of overload due to repetitive use.
Active release technique will be applied on group A by the physiotherapist and self-myofascial release will be applied on group B by the patients themselves through the use of foam-rollers and massage ball to compare the results of both these techniques on reducing pain, improving range and functional disability among individuals with piriformis syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Piriformis Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Group A received Active release technique (ART)
Arm Title
Group B
Arm Type
Other
Arm Description
Group B received self-myofascial release (SMFR)
Intervention Type
Other
Intervention Name(s)
Active release technique
Intervention Description
Active Release Technique was applied to patient in prone lying, knee flexed at 90. The therapist placed his elbow tip on taut band of piriformis and direct pressure applied, patient wias then asked to do internal rotation of hip, in order to achieve lengthening of the muscle. This was repeated 5-7 times.
A total of 18 sessions was given over a period of 6 weeks (3 sessions per week)
Intervention Type
Other
Intervention Name(s)
Self-myofascial release
Intervention Description
Patient position in prone lying Therapist was standing beside the patient at the waistline, working on the contralateral side.
Piriformis muscle was located by an imaginary line drawn between the midpoint of the lateral aspect of the sacrum and the greater trochanter. A contact was established in the gluteal area about 3 cm from the sacrum. Patent was guided to use a foam roller followed by a massage ball.
A total of 18 sessions were given over a period of 6 weeks (3 sessions per week)
Primary Outcome Measure Information:
Title
Likert pain scale (change is being assessed)
Description
Pain intensity is principally assessed using rating scales such as the 11-point Likert scale. In general, frequent pain assessments are serially correlated and underdispersed. The aim of this investigation was to develop population models adapted to fit the 11-point pain scale.
Time Frame
Change from Baseline at 6 weeks
Title
Lower extremity functional scale (change is being assessed)
Description
The lower extremity functional scale (LEFS) is a valid patient-rated outcome measure (PROM) for the measurement of lower extremity function.
The maximum possible score is 80 points, indicating very high function. The minimum possible score is 0 points, indicating very low function.
Time Frame
Change from Baseline at 6 weeks
Title
Range of Motion by Goniometer (change is being assessed)
Description
Range of straight leg raise (SLR) and Internal rotation range would be measured
Time Frame
Change from Baseline range of motion at 6 weeks
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:
20-40 years
males and females
Pain more than 1 month.
Piriformis syndrome diagnosed through screening tests (FAIR test, Beatty test, Freiberg test, Sign of Pace)
A score ≥8 on a 12-point Clinical scoring system for diagnosis of piriformis syndrome
Exclusion Criteria:
Inflammation, malignancy, arthritis, active infection, post-partum or pregnant females and post-op patients, any deformity.
Leg pain due to causes other than piriformis syndrome
Any traumatic History.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramsha Akbar
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sehat Medical Complex, Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
55201
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Comparative Effect of Active Release Technique Versus Self-myofascial Release in Improving Piriformis Syndrome
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