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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05848063
Other study ID # REC/RCR & AHS/23/0102
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2023
Est. completion date August 25, 2023

Study information

Verified date September 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 25, 2023
Est. primary completion date August 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Global hip muscles strengthening exercises
Strengthening exercises will be given to all hip muscles
Hip abductors strengthening exercises
Strengthening exercises will be given to hip abductor muscles

Locations

Country Name City State
Pakistan Riphah rehabilitation clinic, Lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. follow up at 12th week
Primary 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). follow up at 12th week
Primary 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. follow up at 12th week
Primary 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 follow up at 12th week
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