NCT05848063

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

April 18, 2023

Last Update Submit

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

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.

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.

Other: Hip abductors strengthening exercises

Interventions

Strengthening exercises will be given to all hip muscles

Group A: Global hip muscles strengthening exercises

Strengthening exercises will be given to hip abductor muscles

Group B: Hip abductors strengthening exercises

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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: 30408241BACKGROUND
  • 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.

    PMID: 22327640BACKGROUND
  • 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.

    PMID: 29184293BACKGROUND
  • 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.

    PMID: 19010285BACKGROUND
  • 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.

    PMID: 30528358BACKGROUND

MeSH Terms

Conditions

Piriformis Muscle Syndrome

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Study Officials

  • maria Abbas chishty, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

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

Locations