Piriformis SyndromeNCT05742633
Comparative Effect of Active Release Technique Versus Self-myofascial Release in Improving Piriformis Syndrome
A study testing Active release technique and Self-myofascial release in people with Piriformis Syndrome, run by Sehat Medical Complex at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Piriformis Syndrome
- What is being tested?
- Active release technique and Self-myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Feb 2023to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effect of Active Release Technique Versus Self-myofascial Release in Improving Piriformis Syndrome. A Randomized Controlled Trial
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.
- Conditions
- Piriformis Syndrome
- Being tested
- Active release technique, Self-myofascial release
- Medical subject headings
- Piriformis Muscle Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active release techniqueOther
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)
Self-myofascial releaseOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A received Active release technique (ART) Receives: Other: Active release technique |
| Group B | Other | Group B received self-myofascial release (SMFR) Receives: Other: Self-myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Change from Baseline range of motion at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start3 Feb 2023
- Primary completion30 May 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Piriformis SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehat Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waseem Javaid, Sehat Medical Complex
- Investigators
- Ramsha Akbar, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742633
- Sponsor's protocol ID
- ramshaakbar20
- Status last verified
- Aug 2023
- First submitted
- 15 Feb 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Active Release Technique Versus Self-myofascial Release in Improving Piriformis Syndrome. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05742633
- Acronym / sponsor ID
- ramshaakbar20
- Conditions
- Piriformis Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Sehat Medical ComplexUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Active release techniqueGroup A received Active release technique (ART) |
| Group B | Other | Other: Self-myofascial releaseGroup B received self-myofascial release (SMFR) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active release techniqueActive 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) | Other | Group A |
| Self-myofascial releasePatient 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) | Other | Group B |
Primary outcome
Likert pain scale (change is being assessed)
Time frame: Change from Baseline at 6 weeks
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)
Time frame: Change from Baseline at 6 weeks
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)
Time frame: Change from Baseline range of motion at 6 weeks
Range of straight leg raise (SLR) and Internal rotation range would be measured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
Related trials for Piriformis Syndrome
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Comparative Effects of Post-Isometric Relaxation and Reciprocal Inhibition Techniques inPiriformis Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramsha Akbar principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active release technique and Self-myofascial release in people with Piriformis Syndrome, run by Sehat Medical Complex at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Likert pain scale (change is being assessed) (time frame: Change from Baseline at 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.