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

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.

Study Overview

• Status: Completed
• Conditions: Piriformis Syndrome
• Intervention / Treatment: Other: Hold Relax with Agonist Contraction; Other: Active Release Therapy

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayesha Jamil, M.Phil; Phone Number: 03244481031; Email: ayeshabutt031@gmail.com
• Study Contact Backup: Name: Nimra Ilyas, MS.; Phone Number: 03334239856; Email: nimraawan333@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • The University of Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Intermittent vascular claudication and spondylolisthesis.
2. Past history of hip, femur or vertebral fracture
3. Past history of spinal surgery.
4. Spinal tuberculosis.
5. Rheumatoid disease.
6. Disc pathology, sacroiliac joint dysfunction or mechanical back pain.
7. History of infectious disease.
8. Leg length discrepancy.
9. Any postural abnormality or deformity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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; Participant will be in prone lying and heating pad will be applied on gluteal region for 10 to 15 minutes.; Passive sustained stretch to piriformis will be applied for 10 seconds.; The participant will be asked to actively contract the muscle for about 10 seconds (isometric contraction) and then relax.; Immediately after that participant is ask to again actively contract the muscle against therapist resistance for 6-10 seconds.; 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.; This maneuver is repeated for 3 to 4 repetitions, each starting from where the previous finished.; Other Names: Proprioceptive Neuromuscular Facilitation Technique
Active Comparator: Group B; 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; Specific muscle will be warmed up by applying heating pad for 10 to 15 minutes.; Patient will be positioned prone lying and the therapist will be standing at the side of affected limb.; Therapist will apply deep pressure at the area of tenderness while patient will actively move the limb from internal to external rotation repeatedly.; This maneuver will take about 15 minutes to complete in one session and will be applied alternatively 3 days a week for two weeks.; After this, cold pack is applied and general ROMs and strengthening exercises are performed to prevent soreness; Other Names: Soft Tissue Mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Lahore
• Investigators: Study Chair: Ayesha Jamil, M.Phil, The University of Lahore

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Actual): November 22, 2022
• Study Completion (Actual): November 22, 2022

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Function, Pain,Hold Relax ,Sleep Quality, Mobilization
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Nerve Compression Syndromes; Pelvic Pain; Syndrome; Piriformis Muscle Syndrome
• Other Study ID Numbers: Nimra Ilyas

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlies the results reported in article after deidentification
• IPD Sharing Time Frame: Immediately following publication. Ending in 36 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No