Effects of Hold Relax With Agonist Contraction and Active Release Therapy on Clinical Outcomes in Piriformis Syndrome
Comparative Effects of Hold Relax With Agonist Contraction and Active Release Therapy on Pain, Functional Disability and Sleep Quality in Piriformis Syndrome
1 other identifier
interventional
82
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
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
February 22, 2022
CompletedFirst Submitted
Initial submission to the registry
May 6, 2022
CompletedFirst Posted
Study publicly available on registry
May 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2022
CompletedApril 6, 2023
April 1, 2023
9 months
May 6, 2022
April 5, 2023
Conditions
Keywords
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
EXPERIMENTALThis 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.
Group B
ACTIVE COMPARATORThis 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.
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.
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
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ayesha Jamil, M.Phil
University of Lahore
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
- 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
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Immediately following publication. Ending in 36 months.
Individual participant data that underlies the results reported in article after deidentification