NCT06534788

Brief Summary

This study is a randomized controlled trial and the purpose of this study is to compare the effects of reciprocal inhibition versus post facilitation muscle energy technique along with conventional physical therapy in patients with piriformis syndrome in terms of pain, range of motion at hip joint and functional disability.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 31, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

July 30, 2024

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain Intensity

    The pre and post pain intensity will be measured using Numeric Pain Rating Scale (NPRS) comprising of 11 points from 0 - 10 where 0 indicates "no pain" while 10 is "maximally felt pain".

    2 weeks

  • Hip range of motion

    Goniometer will be used to measure the pre and post treatment ranges of internal rotation, external rotation, abduction and adduction at hip joint in supine and sitting positions.

    2 weeks

  • Functional Disability

    Lower Extremity Functional Scale comprising of 20 questions regarding lower extremity function will be used. The maximum possible score is 80 points, indicating very high function. The minimum possible score is 0 points, indicating very low function.

    2 weeks

Study Arms (2)

RI-MET group

EXPERIMENTAL

RI-MET group A will receive 3-5 repetitions of reciprocal inhibition to the shortened piriformis muscle in supine and prone positions i.e. 30-50% isometric contraction of the muscle opposite to the muscle to be stretched for 7-10 seconds, followed by inhalation, exhalation and rest period of 5 seconds and then a stretch (through the new barrier with patients' assistance) of 10-60 seconds hold.both groups will receive conventional physical therapy which they will be taught as a home plan. Following exercises are guided to the patient as home plan. * Resisted abduction with Thera/resistance band * Resisted bridging with Thera/resistance band * Resisted clam exercise with Thera/resistance band

Other: Reciprocal Inhibition METOther: Conventional physical therapy

PFS-MET group

EXPERIMENTAL

PFS-MET group will receive 3-5 repetitions of post-facilitation stretch to the shortened piriformis muscle in supine and prone positions i.e. 20% maximal isometric contraction of the muscle to be stretched for 6-10 seconds, followed by a rapid stretch (through the new barrier) of 15 seconds hold. After stretch, the muscle is allowed to relax in the midrange for up to 30 seconds.Both groups will receive conventional physical therapy which they will be taught as a home plan. Following exercises are guided to the patient as home plan. * Resisted abduction with Thera/resistance band * Resisted bridging with Thera/resistance band * Resisted clam exercise with Thera/resistance band

Other: Post-facilitation METOther: Conventional physical therapy

Interventions

Reciprocal Inhibition MET will be applied to the shortened piriformis muscle in supine and prone positions with participants using 30-50% of their maximum voluntary isometric contraction. It will include 30-50% isometric contraction of the muscle opposite to the muscle to be stretched for 7-10 seconds, followed by inhalation, exhalation and rest period of 5 seconds and then a stretch (through the new barrier with patients' assistance) of 10-60 seconds hold. RI-MET group will receive 3-5 repetitions.

RI-MET group

Post-facilitation stretch technique for shortened piriformis muscle in supine and prone positions will be applied with participants using 20% of their maximum voluntary isometric contraction. It will include 20% maximal isometric contraction of the muscle to be stretched for 6-10 seconds, followed by a rapid stretch (through the new barrier) of 15 seconds hold. After stretch, the muscle is allowed to relax in the midrange for up to 30 seconds. PFS-MET group will receive 3-5 repetitions.

PFS-MET group

TENS and hot pack application to provide heating effect over the painful area (10 minutes) Both groups will receive conventional physical therapy which they will be taught as a home plan. Following exercises are guided to the patient as home plan. * Resisted abduction with Thera/resistance band * Resisted bridging with Thera/resistance band * Resisted clam exercise with Thera/resistance band

PFS-MET groupRI-MET group

Eligibility Criteria

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

You may qualify if:

  • Age: 20-50 years
  • Both Genders
  • Chronic pain in buttock and hip area (≥ 3 on NPRS) lasting more than 3 months.
  • Shortened piriformis muscle (Internal rotation less than 30°) on muscle length assessment.
  • A score of ≥ 8 on a 12-point clinical scoring system.
  • At least two positive screening tests.

You may not qualify if:

  • Active infection
  • Lower lumbar radiculopathy
  • Sacroiliac joint dysfunction
  • Malignancies
  • History of trauma
  • Hip Arthroplasty
  • Rheumatoid/ Osteoarthritis
  • Any neurological dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

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

Central Study Contacts

Nimrah Haq, MS-MSKPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This will be a single blinded study because the treatment of both study group and control group will be done by the researcher and only the participants will be kept blinded about the allocation of participants to either the active comparator group or experimantal group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 2, 2024

Study Start

May 31, 2024

Primary Completion

January 15, 2025

Study Completion

January 30, 2025

Last Updated

August 2, 2024

Record last verified: 2024-07

Locations