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Effects of Global Hip Versus Isolated Abductors Strengthening Exercises in Patients Withsecondary Piriformis Syndrome

Primary Purpose

Piriformis Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Global hip muscles strengthening exercises
Hip abductors strengthening exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Piriformis Syndrome

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Riphah rehabilitation clinic, Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A: Global hip muscles strengthening exercises

Group B: Hip abductors strengthening exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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).
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.
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

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
September 15, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05848063
Brief Title
Effects of Global Hip Versus Isolated Abductors Strengthening Exercises in Patients Withsecondary Piriformis Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
August 5, 2023 (Actual)
Study Completion Date
August 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Piriformis Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Global hip muscles strengthening exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B: Hip abductors strengthening exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Global hip muscles strengthening exercises
Intervention Description
Strengthening exercises will be given to all hip muscles
Intervention Type
Other
Intervention Name(s)
Hip abductors strengthening exercises
Intervention Description
Strengthening exercises will be given to hip abductor muscles
Primary Outcome Measure Information:
Title
Numeric Pain Rating scale
Description
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.
Time Frame
follow up at 12th week
Title
Hand held dynamometer:
Description
Using a Jamar hydraulic hand-held dynamometer, the isometric muscle strength ofthe involved hip abductor and extensor muscles will be measured (JHHD).
Time Frame
follow up at 12th week
Title
Goniometer:
Description
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.
Time Frame
follow up at 12th week
Title
Lower extremity function scale:
Description
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
Time Frame
follow up at 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
maria Abbas chishty, MS*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah rehabilitation clinic, Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30408241
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.
Results Reference
background
PubMed Identifier
22327640
Citation
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.
Results Reference
background
PubMed Identifier
29184293
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.
Results Reference
background
PubMed Identifier
19010285
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.
Results Reference
background
PubMed Identifier
30528358
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.
Results Reference
background

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Effects of Global Hip Versus Isolated Abductors Strengthening Exercises in Patients Withsecondary Piriformis Syndrome

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