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CompletedNCT05742633Updated Sep 5, 2023

Comparative Effect of Active Release Technique Versus Self-myofascial Release in Improving Piriformis Syndrome

An interventional study of Active release technique and Self-myofascial release in Piriformis Syndrome, sponsored by Sehat Medical Complex. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-09-05.

Sponsored by Sehat Medical Complex · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Piriformis Syndrome
03

In context

Piriformis Muscle Syndrome

56 studies on the registry are indexed under Piriformis Muscle Syndrome; 23 are open to participants now.

This study's enrollment of 82 is above the median of 42 across 50 interventional studies indexed under Piriformis Muscle Syndrome.

Browse Piriformis Muscle Syndrome studies →

Lead sponsor

Sehat Medical Complex is the lead sponsor of 25 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Group A

    Group A received Active release technique (ART)

    Other: Active release technique

  • Other
    Group B

    Group B received self-myofascial release (SMFR)

    Other: Self-myofascial release

Interventions

  • OtherActive release technique

    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)

  • OtherSelf-myofascial release

    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)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from Baseline at 6 weeks

  2. 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.

    Time frame: Change from Baseline at 6 weeks

  3. Range of Motion by Goniometer (change is being assessed)

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

    Time frame: Change from Baseline range of motion at 6 weeks

07

Study locations

1 site
  • Sehat Medical Complex, Lahore
    Lahore, Punjab Province 55201, Pakistan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2023 to primary completion in May 2023, 3 months.

Of 36 non-industry interventional studies with no phase under Piriformis Muscle Syndrome, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 12. This study's 3 months is below that.

Counting every sponsor, half of 36 studies reached it within 6 months; a quarter within 4 and three quarters within 12.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2023
First posted
Feb 24, 2023
StartActual
Feb 3, 2023
Primary completionActual
May 30, 2023
CompletionActual
Jun 15, 2023
Last update
Sep 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05742633
Lead sponsor
Sehat Medical Complex
Responsible party
Waseem Javaid (Project Director, Sehat Medical Complex) — Principal investigator
First posted
Feb 24, 2023
Start date
Feb 3, 2023
Primary completion
May 30, 2023
Completion
Jun 15, 2023
Last update
Sep 5, 2023

Study contacts

Ramsha Akbar
principal investigator · University of Lahore

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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