NCT05742633

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

February 15, 2023

Last Update Submit

August 31, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    Change from Baseline at 6 weeks

  • 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.

    Change from Baseline at 6 weeks

  • Range of Motion by Goniometer (change is being assessed)

    Range of straight leg raise (SLR) and Internal rotation range would be measured

    Change from Baseline range of motion at 6 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Group A received Active release technique (ART)

Other: Active release technique

Group B

OTHER

Group B received self-myofascial release (SMFR)

Other: Self-myofascial release

Interventions

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)

Group A

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)

Group B

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehat Medical Complex, Lahore

Lahore, Punjab Province, 55201, Pakistan

Location

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

  • Ramsha Akbar

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Director

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 24, 2023

Study Start

February 3, 2023

Primary Completion

May 30, 2023

Study Completion

June 15, 2023

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations