Effectiveness of Iliopsoas Positional Release Versus Conventional Exercises in the Management of Sub-acute Back Pain.

February 21, 2024 updated by: Iram Iqbal Shamsi, University of Karachi

Effectiveness of Iliopsoas Positional Release Versus Conventional Exercises in the Management of Sub-acute Back Pain in Pakistani Population

Recommended treatment for chronic non-specific LBP is exercise therapy, behavioral therapy including pain management, or a combination of these; There is not enough evidence to establish recommendations for which one is the most appropriate.

The primary objective of this study is to explore the effects of Ilio-psoas Release on Sub-acute back pain, ROM & functional disability

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Following the screening, participants will be randomized to receive the experimental or the controlled treatment in a1:1 ratio. Computer-generated random numbers will be used for Randomization. After obtaining the basic information, a unique code will be provided to each included patient. The outcome assessor will be blinded to the type of treatment. Patients and investigator could not be blinded due to the nature of treatment.

Group "A "(experimental group) will receive Positional Release Technique on Painful Iliopsoas(Both if Necessary) Group "B" (control group) will receive conventional physical therapy treatment consisting of hot pack, TENS, Ultra Sound along with back strengthening exercises.

All patients will be Assessed for Pain , ROM and Functional Activities before and after treatment sessions.

Visual Analogue Scale(VAS) and Modified Schober Test will be used for pain and ROM respectively. Roland-Morris Questionnaire (RMQ) will be used for functional activities.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Recruiting
        • Sindh Institute of Physical Medicine and Rehabilitation
        • Contact:
          • Iram I Shamsi, MPhil
        • Principal Investigator:
          • Iram I Shamsi, MPhil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Sub-acute (pain for > 1.5 month)
  • Age 18-40 years
  • Willing to participate
  • Both gender will be recruited.

Exclusion Criteria:

  • Any history related to spinal surgery
  • Previous administration of epidural injections
  • LBP due to specific pathology
  • Neurological deficits (like stroke)
  • Clinical disorder contraindicated to exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iliopsoas positional release
Group A (Iliopsoas positional release group) Positional release therapy will be administered on both Iliopsoas muscles, three sets on each side with 30 seconds hold on tender point. A rest of 15 seconds will be given between all sets.
Other: Iliopsoas Positional release therapy
Group A(Iliopsoas Positional release group) Patient supine, with both hips are fully extended .Find a Tender point in Iliopsoas muscle, at the initiation of pain Passively try combination of flexion Adduction/Abduction medial or lateral rotation at hip joint and stop where pain start to diminished. Hold this position of relief for 30 seconds until minimum of 75% of relief is achieved. Apply three times, than passively take lower limb in extension. Administered on both limbs.
Other Names:
  • Strain Counter-strain therapy
Active Comparator: Conventional therapy
Group B (Conventional therapy) Conventional Physical therapy i.e. Ultrasonic therapy 3 min 1 MHz, TENS 10 min, hot pack for 10 min and back strengthening exercises.
Other: Conventional exercises
Group B (conventional Physical therapy) For Ultra sonic therapy Patient prone lying, Aqua-sonic gel is applied to lumbosacral area and ultrasonic head is moved in circular motion. For TENS Electrodes are placed in crossed pattern, Paravertebral at L1 and L5 (Box Pattern)with circuit crossing at L3 and current is applied for 10 minutes, Hot pack which is kept in hydro-collateral at 70°C and 75°C is, wrapped in several towel layers, applied for 10 minutes.
Other Names:
  • conventional physical therapy treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS Visual Analogue Scale VAS Visual Analogue Scale
Time Frame: Baseline and After Four weeks of Treatment
The visual analogue scale is used for measurement of pain intensity. It is a continuous scale. It comprises a horizontal or vertical 10 centimeters or 100 millimeters line. The higher scores shows higher pain intensity and lower scores shows lower pain intensity.
Baseline and After Four weeks of Treatment
Modified Schober's test
Time Frame: Baseline and After Four weeks of Treatment
It is used during physical examination to assess the lumbar range of movement. It is highly co-related with lumbar range of movement measured through radiograph. Higher score reflect better range of motion of Spine.
Baseline and After Four weeks of Treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Roland-Morris Disability Questionnaire
Time Frame: Baseline and After Four weeks of Treatment

The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities.0 Score means No disability and score 24 means severe disability.

Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability).Reduction in score shows Improvement
Baseline and After Four weeks of Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Karachi

Collaborators

Sindh Institute of Physical Medicine and Rehabilitation

Investigators

  • Principal Investigator: Iram I Shamsi, M.Phil., Sind Institute of Physical Medicine & Rehabilitation
  • Study Chair: Basit Ansari, PhD, University of Karachi
  • Study Director: Aftab A Mirza Baig, PhD, IQRA University
  • Study Director: Syed A Ali, PhD, Government degree Science & commerce college

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2024

Primary Completion (Estimated)

February 15, 2025

Study Completion (Estimated)

February 25, 2025

Study Registration Dates

First Submitted

February 11, 2024

First Submitted That Met QC Criteria

February 11, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IShamsi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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