NCT05370378

Brief Summary

The aim of this study is to compare the effects of hold relax agonist contraction and active release therapy on reducing pain intensity, improving functioning and sleep quality in patient with piriformis syndrome. Both these techniques are passive, non-invasive manual therapy techniques which are easy to perform and less time consuming and may yield better outcomes resulting improved quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2022

Completed
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

May 6, 2022

Last Update Submit

April 5, 2023

Conditions

Keywords

Function, Pain,Hold Relax ,Sleep Quality, Mobilization

Outcome Measures

Primary Outcomes (3)

  • Change in Pain Intensity

    Numeric Pain Rating Scale will be used to measure the intensity of pain

    Pain score will be measured at the baseline, at end of first session and at 6th session on 2nd week

  • Change in Functional Disability

    Ronald-Morris Disability Questionnaire will be used to a assess the level of disability

    Change in functional status will be measured at the baseline, at end of first session and at end of 6th session

  • Sleep Quality

    Chronic Pain Sleep Inventory will be used to to assess the quality of sleep on a 100 mm VAS scale

    Sleep quality will be measured at the baseline, at end of first session and at end of 6th session

Study Arms (2)

Group A

EXPERIMENTAL

This group of participants will receive Hold Relax with Agonist Contraction (HR-AC) technique with routine physical therapy. The protocol will be given to the participants for two weeks (6 sessions on alternate days, 3 session per week). Each session will be of 60 minutes. The data will be collected before applying intervention, at first week and at 2nd week.

Other: Hold Relax with Agonist Contraction

Group B

ACTIVE COMPARATOR

This group of participants will receive Active Release Therapy, a kind of soft tissue mobilization along with routine physical therapy. The protocol will be given to the participants for two weeks (6 sessions on alternate days, 3 session per week). Each session will be of 60 minutes. The data will be collected before applying intervention, at first week and at 2nd week.

Other: Active Release Therapy

Interventions

1. Participant will be in prone lying and heating pad will be applied on gluteal region for 10 to 15 minutes. 2. Passive sustained stretch to piriformis will be applied for 10 seconds. 3. The participant will be asked to actively contract the muscle for about 10 seconds (isometric contraction) and then relax. 4. Immediately after that participant is ask to again actively contract the muscle against therapist resistance for 6-10 seconds. 5. Ask the participant to relax while therapist will apply stretch the muscle to its new tissue tension barrier position and this position will be maintained for 30 seconds. 6. This maneuver is repeated for 3 to 4 repetitions, each starting from where the previous finished.

Also known as: Proprioceptive Neuromuscular Facilitation Technique
Group A

1. Specific muscle will be warmed up by applying heating pad for 10 to 15 minutes. 2. Patient will be positioned prone lying and the therapist will be standing at the side of affected limb. 3. Therapist will apply deep pressure at the area of tenderness while patient will actively move the limb from internal to external rotation repeatedly. 4. This maneuver will take about 15 minutes to complete in one session and will be applied alternatively 3 days a week for two weeks. 5. After this, cold pack is applied and general ROMs and strengthening exercises are performed to prevent soreness

Also known as: Soft Tissue Mobilization
Group B

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age group 25-55 years
  • Both male and female.
  • Gluteal pain with or without radicular symptoms.
  • Patients of piriformis syndrome diagnosed by orthopedic consultant.
  • Sub-acute and chronic piriformis syndrome.
  • Unilateral pain.
  • Pain score equal to and greater than 3 according to pain rating scale.

You may not qualify if:

  • Intermittent vascular claudication and spondylolisthesis.
  • Past history of hip, femur or vertebral fracture
  • Past history of spinal surgery.
  • Spinal tuberculosis.
  • Rheumatoid disease.
  • Disc pathology, sacroiliac joint dysfunction or mechanical back pain.
  • History of infectious disease.
  • Leg length discrepancy.
  • Any postural abnormality or deformity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

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

  • Ayesha Jamil, M.Phil

    University of Lahore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Opaque Sealed Envelops will be provided to participants by investigator, with mentioned treatment group. A separate therapist serving as outcome assessor will be unaware of treatment group provided.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group A: Hold Relax with Agonist Contraction with Routine Physical Therapy Group B: Active Release Therapy with Routine Physical Therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ayesha Jamil

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 11, 2022

Study Start

February 22, 2022

Primary Completion

November 22, 2022

Study Completion

November 22, 2022

Last Updated

April 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Individual participant data that underlies the results reported in article after deidentification

Shared Documents
STUDY PROTOCOL
Time Frame
Immediately following publication. Ending in 36 months.

Locations