Effects of Global Hip Versus Isolated Abductors Strengthening Exercises in Patients Withsecondary Piriformis Syndrome
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2023
CompletedFirst Submitted
Initial submission to the registry
April 18, 2023
CompletedFirst Posted
Study publicly available on registry
May 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2023
CompletedSeptember 18, 2023
September 1, 2023
5 months
April 18, 2023
September 15, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
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
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
Study Arms (2)
Group A: Global hip muscles strengthening exercises
EXPERIMENTALGroup 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 COMPARATORGroup 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.
Interventions
Strengthening exercises will be given to all hip muscles
Strengthening exercises will be given to hip abductor muscles
Eligibility Criteria
You may qualify if:
- Both Genders
- age: 20-50 years
- Batty test to diagnose secondary piriformis syndrome
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Riphah rehabilitation clinic, Lahore
Lahore, Punjab Province, 54700, Pakistan
Related Publications (5)
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.
PMID: 30408241BACKGROUNDCassidy 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.
PMID: 22327640BACKGROUNDPark 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.
PMID: 29184293BACKGROUNDFiller 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.
PMID: 19010285BACKGROUNDShah 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.
PMID: 30528358BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
maria Abbas chishty, MS*
Riphah International University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2023
First Posted
May 8, 2023
Study Start
March 15, 2023
Primary Completion
August 5, 2023
Study Completion
August 25, 2023
Last Updated
September 18, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share