Piriformis SyndromeNCT05370378
Effects of Hold Relax With Agonist Contraction and Active Release Therapy on Clinical Outcomes in Piriformis Syndrome
A study testing Hold Relax with Agonist Contraction and Active Release Therapy in people with Piriformis Syndrome, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Piriformis Syndrome
- What is being tested?
- Hold Relax with Agonist Contraction and Active Release Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Feb 2022to 22 Nov 2022
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- History of infectious disease.
- Leg length discrepancy.
- Any postural abnormality or deformity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Hold Relax With Agonist Contraction and Active Release Therapy on Pain, Functional Disability and Sleep Quality in Piriformis Syndrome
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.
- Conditions
- Piriformis Syndrome
- Being tested
- Hold Relax with Agonist Contraction, Active Release Therapy
- Keywords
- Function, Pain,Hold Relax ,Sleep Quality, Mobilization
- 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.
Hold Relax with Agonist ContractionOther
Also called Proprioceptive Neuromuscular Facilitation Technique
- 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.
Active Release TherapyOther
Also called Soft Tissue Mobilization
- 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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Other: Hold Relax with Agonist Contraction |
| Group B | Active comparator | 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. Receives: Other: Active Release Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Numeric Pain Rating Scale will be used to measure the intensity of pain
Measured: Pain score will be measured at the baseline, at end of first session and at 6th session on 2nd week
Change in Functional Disability
Ronald-Morris Disability Questionnaire will be used to a assess the level of disability
Measured: Change in functional status will be measured at the baseline, at end of first session and at end of 6th session
Sleep Quality
Chronic Pain Sleep Inventory will be used to to assess the quality of sleep on a 100 mm VAS scale
Measured: Sleep quality will be measured at the baseline, at end of first session and at end of 6th session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start22 Feb 2022
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
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.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- Model description
- Group A: Hold Relax with Agonist Contraction with Routine Physical Therapy Group B: Active Release Therapy with Routine Physical Therapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Jamil, University of Lahore
- Investigators
- Ayesha Jamil, M.Phil, Study chair, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370378
- Sponsor's protocol ID
- Nimra Ilyas
- Status last verified
- Apr 2023
- First submitted
- 6 May 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlies the results reported in article after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Hold Relax With Agonist Contraction and Active Release Therapy on Pain, Functional Disability and Sleep Quality in Piriformis Syndrome
- ClinicalTrials.gov ID
- NCT05370378
- Acronym / sponsor ID
- Nimra Ilyas
- Conditions
- Piriformis Syndrome
- Keywords
- Function, Pain,Hold Relax ,Sleep Quality, Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 11 May 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group A: Hold Relax with Agonist Contraction with Routine Physical Therapy Group B: Active Release Therapy with Routine Physical Therapy
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Hold Relax with Agonist ContractionThis 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. |
| Group B | Active comparator | Other: Active Release TherapyThis 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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- Intermittent vascular claudication and spondylolisthesis.
- Past history of hip, femur or vertebral fracture
- Past history of spinal surgery.
- Spinal tuberculosis.
- Rheumatoid disease.
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 |
|---|---|---|
| Hold Relax with Agonist ContractionAlso: Proprioceptive Neuromuscular Facilitation Technique1. Participant will be in prone lying and heating pad will be applied on gluteal region for 10 to 15 minutes. 2. Passive sustained stretch to piriformis will be applied for 10 seconds. 3. The participant will be asked to actively contract the muscle for about 10 seconds (isometric contraction) and then relax. 4. Immediately after that participant is ask to again actively contract the muscle against therapist resistance for 6-10 seconds. 5. 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. 6. This maneuver is repeated for 3 to 4 repetitions, each starting from where the previous finished. | Other | Group A |
| Active Release TherapyAlso: Soft Tissue Mobilization1. Specific muscle will be warmed up by applying heating pad for 10 to 15 minutes. 2. Patient will be positioned prone lying and the therapist will be standing at the side of affected limb. 3. Therapist will apply deep pressure at the area of tenderness while patient will actively move the limb from internal to external rotation repeatedly. 4. This maneuver will take about 15 minutes to complete in one session and will be applied alternatively 3 days a week for two weeks. 5. After this, cold pack is applied and general ROMs and strengthening exercises are performed to prevent soreness | Other | Group B |
Primary outcome
Change in Pain Intensity
Time frame: Pain score will be measured at the baseline, at end of first session and at 6th session on 2nd week
Numeric Pain Rating Scale will be used to measure the intensity of pain
Change in Functional Disability
Time frame: Change in functional status will be measured at the baseline, at end of first session and at end of 6th session
Ronald-Morris Disability Questionnaire will be used to a assess the level of disability
Sleep Quality
Time frame: Sleep quality will be measured at the baseline, at end of first session and at end of 6th session
Chronic Pain Sleep Inventory will be used to to assess the quality of sleep on a 100 mm VAS scale
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 6 Apr 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlies the results reported in article after deidentification
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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.
Ayesha Jamil, M.Phil study chair
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 Hold Relax with Agonist Contraction and Active Release Therapy in people with Piriformis Syndrome, run by University of Lahore 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 7 inclusion and 9 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 6 Apr 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?
Change in Pain Intensity (time frame: Pain score will be measured at the baseline, at end of first session and at 6th session on 2nd week). 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 6 Apr 2023.