- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05848063
Effects of Global Hip Versus Isolated Abductors Strengthening Exercises in Patients Withsecondary Piriformis Syndrome
September 15, 2023 updated by: Riphah International University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54700
- Riphah rehabilitation clinic, Lahore
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Both Genders
- age: 20-50 years
- Batty test to diagnose secondary piriformis syndrome
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A: Global hip muscles strengthening exercises
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.
|
Strengthening exercises will be given to all hip muscles
|
Active Comparator: Group B: Hip abductors strengthening exercises
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.
|
Strengthening exercises will be given to hip abductor muscles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
follow up at 12th week
|
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).
|
follow up at 12th week
|
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.
|
follow up at 12th week
|
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
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follow up at 12th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: maria Abbas chishty, MS*, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Park 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.
- 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.
- Cassidy 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.
- Filler 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.
- Shah 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2023
Primary Completion (Actual)
August 5, 2023
Study Completion (Actual)
August 25, 2023
Study Registration Dates
First Submitted
April 18, 2023
First Submitted That Met QC Criteria
May 4, 2023
First Posted (Actual)
May 8, 2023
Study Record Updates
Last Update Posted (Actual)
September 18, 2023
Last Update Submitted That Met QC Criteria
September 15, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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