Piriformis SyndromeNCT05848063
Effects of Global Hip Versus Isolated Abductors Strengthening Exercises in Patients Withsecondary Piriformis Syndrome
A study testing Global hip muscles strengthening exercises and Hip abductors strengthening exercises in people with Piriformis Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will be a randomized controlled trial. Twenty-four subjects will be assigned randomly by using the lottery method into two groups. Group A will be given a hot pack in addition to the global hip muscles strengthening exercise while group B is the control group which will receive a hot pack in addition to hip… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Piriformis Syndrome
- What is being tested?
- Global hip muscles strengthening exercises and Hip abductors strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2023to 25 Aug 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both Genders
- age: 20-50 years
- Batty test to diagnose secondary piriformis syndrome
Who cannot join
- Diagnosed Congenital spinal defects
- Diagnosed Hip arthritis
- Pregnancy
- Diagnosed Disc facet pathology
- History of Spinal trauma
- Musculoskeletal abnormality in the lumbar spine
- Diagnosed Rheumatologic disorders
- Any diagnosed bony or soft tissue systemic disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah rehabilitation clinic, Lahore
Lahore, Punjab Province, 54700
About this study
Official title: Effects of Global Hip Versus Isolated Abductors Muscles Strengthening Exerciseprogram on Pain, Range of Motion, and Lower Extremity Function in Patients Withsecondary Piriformis Syndrome
The study will be a randomized controlled trial. Twenty-four subjects will be assigned randomly by using the lottery method into two groups. Group A will be given a hot pack in addition to the global hip muscles strengthening exercise while group B is the control group which will receive a hot pack in addition to hip abductor strengthening. The time duration will be 6 weeks. Pain intensity will be assessed by NPRS.3 sessions per week will be given for 6 weeks. Outcome measures will be taken at baseline, in 3rd week, and at the end of the 6th week.
Read the detailed description
Secondary piriformis syndrome is a common condition of extra-spinal sciatica which is related to or around the piriformis muscle and irritates the sciatic nerve. Most cases reported are of secondary piriformis syndrome. Secondary piriformis syndrome is caused due to soft tissue inflammation, and muscular spasms, which result in nerve compression. Inflammation occurs due to trauma on the buttock and piriformis muscle contractures. Strengthening exercise program is another physical technique that has been supported by research in numerous areas, which has effects on the reduction of pain, range of motion, and lower extremity function. This study will aim to compare the effects of global hip muscles and isolated hip abductors muscle strengthening exercise programs on pain, range of motion, and lower extremity function in patients with secondary piriformis syndrome. The study will be a randomized controlled trial. Twenty-four subjects will be assigned randomly by using the lottery method into two groups. Group A will be given a hot pack in addition to the global hip muscles strengthening exercise while group B is the control group which will receive a hot pack in addition to hip abductor strengthening. The time duration will be 6 weeks. Pain intensity will be assessed by NPRS.3 sessions per week will be given for 6 weeks. Outcome measures will be taken at baseline, in 3rd week, and at the end of the 6th week. The collected data will be analyzed in the statistical package for the Social Sciences (SPSS) 25.Parametric/Non-parametric tests will be applied after testing the normality of the data.
- Conditions
- Piriformis Syndrome
- Being tested
- Global hip muscles strengthening exercises, Hip abductors strengthening exercises
- 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.
Global hip muscles strengthening exercisesOther
Strengthening exercises will be given to all hip muscles
Hip abductors strengthening exercisesOther
Strengthening exercises will be given to hip abductor muscles
| Study group | Role | What they receive |
|---|---|---|
| Group A: Global hip muscles strengthening exercises | Experimental | Group A Group A will receive hot packs along with all hip muscle strengthening exercises. All exercises were performed for 3 sessions per week for 6 weeks. Outcome measures will be taken at baseline, in 3rd week, and at the end of the 6th week. Receives: Other: Global hip muscles strengthening exercises |
| Group B: Hip abductors strengthening exercises | Active comparator | Group B will receive hot packs along with Hip abductors strengthening. A baseline assessment will be done on eligible participants. 3 sessions were given 3 days per week, Outcome measures will be taken at baseline, in 3rd week, and at the end of the 6th week. Receives: Other: Hip abductors strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating scale
Pain intensity will be assessed by NPRS. The 11-point NPRS (intervals from 0-10) isused to quantify pain intensity; 0 represents no pain, and 10 represent the worst possible agony. The NPRS is an valid and reliable instrument for older persons.Participants will be asked to select the number that most accurately describes theirlevel of pain. At the baseline assessment, following each exercise session during the12-week intervention, and finally at the end of the intervention Programme, the NPRS scores will be recorded.
Measured: follow up at 12th week
Hand held dynamometer:
Using a Jamar hydraulic hand-held dynamometer, the isometric muscle strength ofthe involved hip abductor and extensor muscles will be measured (JHHD).
Measured: follow up at 12th week
Goniometer:
The fulcrum and the body are placedover the joint being measured. The stationary arm is the arm of the goniometer thataligns with the inactive part of the joint measured. It is structurally a part of the bodyand is not movable independently of the body. The moving arm is the arm of the goniometer, which aligns with the mobile part of the joint measured.
Measured: follow up at 12th week
Lower extremity function scale:
The LEFS can be used by clinicians as a measure of patients' initial function, ongoingprogress, and outcome as well as to set functional goals. LEFS to establish functionallevel, set goals, and track progress and outcome. Consider a patient with an initialLEFS score of 46/80. Based on the error at a given point in time for the LEFS of 5points, the clinician can be 90% confident that the actual scale score is between 41and 51. If the patient's condition is deemed to be relatively chronic and is expected tochange slowly, the clinician might select a 2-week time frame for a change in scoreof just at the MDC and MCID of 9 scale points. The short-term goal, therefore, couldbe: "Increase LEFS score to less than or equal to 54/ 80." In setting a short-term goalfor a patient with a relatively acute condition who is predicted to experience changequickly, a shorter time frame of, for example, 1 week with a greater change than theMDC and MCID may be selected
Measured: follow up at 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start15 Mar 2023
- Primary completion5 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Piriformis SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- maria Abbas chishty, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848063
- Sponsor's protocol ID
- REC/RCR & AHS/23/0102
- Status last verified
- Sep 2023
- First submitted
- 18 Apr 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iwanaga J, Eid S, Simonds E, Schumacher M, Loukas M, Tubbs RS. The majority of piriformis muscles are innervated by the superior gluteal nerve. Clin Anat. 2019 Mar;32(2):282-286. doi: 10.1002/ca.23311. Epub 2018 Dec 21.
PubMed 30408241Cassidy L, Walters A, Bubb K, Shoja MM, Tubbs RS, Loukas M. Piriformis syndrome: implications of anatomical variations, diagnostic techniques, and treatment options. Surg Radiol Anat. 2012 Aug;34(6):479-86. doi: 10.1007/s00276-012-0940-0. Epub 2012 Feb 12.
PubMed 22327640Park JC, Shim JH, Chung SH. The effects of three types of piriform muscle stretching on muscle thickness and the medial rotation angle of the coxal articulation. J Phys Ther Sci. 2017 Oct;29(10):1811-1814. doi: 10.1589/jpts.29.1811. Epub 2017 Oct 21.
PubMed 29184293Filler AG. Piriformis and related entrapment syndromes: diagnosis & management. Neurosurg Clin N Am. 2008 Oct;19(4):609-22, vii. doi: 10.1016/j.nec.2008.07.029.
PubMed 19010285Shah SS, Consuegra JM, Subhawong TK, Urakov TM, Manzano GR. Epidemiology and etiology of secondary piriformis syndrome: A single-institution retrospective study. J Clin Neurosci. 2019 Jan;59:209-212. doi: 10.1016/j.jocn.2018.10.069. Epub 2018 Oct 24.
PubMed 30528358
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Global Hip Versus Isolated Abductors Muscles Strengthening Exerciseprogram on Pain, Range of Motion, and Lower Extremity Function in Patients Withsecondary Piriformis Syndrome
- ClinicalTrials.gov ID
- NCT05848063
- Acronym / sponsor ID
- REC/RCR & AHS/23/0102
- Conditions
- Piriformis Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 8 May 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 study will be a randomized controlled trial. Twenty-four subjects will be assigned randomly by using the lottery method into two groups. Group A will be given a hot pack in addition to the global hip muscles strengthening exercise while group B is the control group which will receive a hot pack in addition to hip abductor strengthening. The time duration will be 6 weeks. Pain intensity will be assessed by NPRS.3 sessions per week will be given for 6 weeks. Outcome measures will be taken at baseline, in 3rd week, and at the end of the 6th week.
Detailed description
Secondary piriformis syndrome is a common condition of extra-spinal sciatica which is related to or around the piriformis muscle and irritates the sciatic nerve. Most cases reported are of secondary piriformis syndrome. Secondary piriformis syndrome is caused due to soft tissue inflammation, and muscular spasms, which result in nerve compression. Inflammation occurs due to trauma on the buttock and piriformis muscle contractures. Strengthening exercise program is another physical technique that has been supported by research in numerous areas, which has effects on the reduction of pain, range of motion, and lower extremity function. This study will aim to compare the effects of global hip muscles and isolated hip abductors muscle strengthening exercise programs on pain, range of motion, and lower extremity function in patients with secondary piriformis syndrome. The study will be a randomized controlled trial. Twenty-four subjects will be assigned randomly by using the lottery method into two groups. Group A will be given a hot pack in addition to the global hip muscles strengthening exercise while group B is the control group which will receive a hot pack in addition to hip abductor strengthening. The time duration will be 6 weeks. Pain intensity will be assessed by NPRS.3 sessions per week will be given for 6 weeks. Outcome measures will be taken at baseline, in 3rd week, and at the end of the 6th week. The collected data will be analyzed in the statistical package for the Social Sciences (SPSS) 25.Parametric/Non-parametric tests will be applied after testing the normality of the data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Global hip muscles strengthening exercises | Experimental | Other: Global hip muscles strengthening exercisesGroup A Group A will receive hot packs along with all hip muscle strengthening exercises. All exercises were performed for 3 sessions per week for 6 weeks. Outcome measures will be taken at baseline, in 3rd week, and at the end of the 6th week. |
| Group B: Hip abductors strengthening exercises | Active comparator | Other: Hip abductors strengthening exercisesGroup B will receive hot packs along with Hip abductors strengthening. A baseline assessment will be done on eligible participants. 3 sessions were given 3 days per week, Outcome measures will be taken at baseline, in 3rd week, and at the end of the 6th week. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both Genders
- age: 20-50 years
- Batty test to diagnose secondary piriformis syndrome
Key exclusion criteria (8 listed)
- Diagnosed Congenital spinal defects
- Diagnosed Hip arthritis
- Pregnancy
- Diagnosed Disc facet pathology
- History of Spinal trauma
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 |
|---|---|---|
| Global hip muscles strengthening exercisesStrengthening exercises will be given to all hip muscles | Other | Group A: Global hip muscles strengthening exercises |
| Hip abductors strengthening exercisesStrengthening exercises will be given to hip abductor muscles | Other | Group B: Hip abductors strengthening exercises |
Primary outcome
Numeric Pain Rating scale
Time frame: follow up at 12th week
Pain intensity will be assessed by NPRS. The 11-point NPRS (intervals from 0-10) isused to quantify pain intensity; 0 represents no pain, and 10 represent the worst possible agony. The NPRS is an valid and reliable instrument for older persons.Participants will be asked to select the number that most accurately describes theirlevel of pain. At the baseline assessment, following each exercise session during the12-week intervention, and finally at the end of the intervention Programme, the NPRS scores will be recorded.
Hand held dynamometer:
Time frame: follow up at 12th week
Using a Jamar hydraulic hand-held dynamometer, the isometric muscle strength ofthe involved hip abductor and extensor muscles will be measured (JHHD).
Goniometer:
Time frame: follow up at 12th week
The fulcrum and the body are placedover the joint being measured. The stationary arm is the arm of the goniometer thataligns with the inactive part of the joint measured. It is structurally a part of the bodyand is not movable independently of the body. The moving arm is the arm of the goniometer, which aligns with the mobile part of the joint measured.
Lower extremity function scale:
Time frame: follow up at 12th week
The LEFS can be used by clinicians as a measure of patients' initial function, ongoingprogress, and outcome as well as to set functional goals. LEFS to establish functionallevel, set goals, and track progress and outcome. Consider a patient with an initialLEFS score of 46/80. Based on the error at a given point in time for the LEFS of 5points, the clinician can be 90% confident that the actual scale score is between 41and 51. If the patient's condition is deemed to be relatively chronic and is expected tochange slowly, the clinician might select a 2-week time frame for a change in scoreof just at the MDC and MCID of 9 scale points. The short-term goal, therefore, couldbe: "Increase LEFS score to less than or equal to 54/ 80." In setting a short-term goalfor a patient with a relatively acute condition who is predicted to experience changequickly, a shorter time frame of, for example, 1 week with a greater change than theMDC and MCID may be selected
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 18 Sep 2023.
- Background: PubMed 30408241Iwanaga J, Eid S, Simonds E, Schumacher M, Loukas M, Tubbs RS. The majority of piriformis muscles are innervated by the superior gluteal nerve. Clin Anat. 2019 Mar;32(2):282-286. doi: 10.1002/ca.23311. Epub 2018 Dec 21.
- Background: PubMed 22327640Cassidy L, Walters A, Bubb K, Shoja MM, Tubbs RS, Loukas M. Piriformis syndrome: implications of anatomical variations, diagnostic techniques, and treatment options. Surg Radiol Anat. 2012 Aug;34(6):479-86. doi: 10.1007/s00276-012-0940-0. Epub 2012 Feb 12.
- Background: PubMed 29184293Park JC, Shim JH, Chung SH. The effects of three types of piriform muscle stretching on muscle thickness and the medial rotation angle of the coxal articulation. J Phys Ther Sci. 2017 Oct;29(10):1811-1814. doi: 10.1589/jpts.29.1811. Epub 2017 Oct 21.
- Background: PubMed 19010285Filler AG. Piriformis and related entrapment syndromes: diagnosis & management. Neurosurg Clin N Am. 2008 Oct;19(4):609-22, vii. doi: 10.1016/j.nec.2008.07.029.
- Background: PubMed 30528358Shah SS, Consuegra JM, Subhawong TK, Urakov TM, Manzano GR. Epidemiology and etiology of secondary piriformis syndrome: A single-institution retrospective study. J Clin Neurosci. 2019 Jan;59:209-212. doi: 10.1016/j.jocn.2018.10.069. Epub 2018 Oct 24.
- Individual participant dataSharing planned: No
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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.
maria Abbas chishty, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global hip muscles strengthening exercises and Hip abductors strengthening exercises in people with Piriformis Syndrome, run by Riphah International University 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 3 inclusion and 8 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 18 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?
Numeric Pain Rating scale (time frame: follow up at 12th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05848063, which also lists 5 linked publications.
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 18 Sep 2023.