Effects of Physical Therapy on Low Back Pain, Disc Height Index, Postural Stability, Disability, Gait and Function in Persons With Postero-lateral Disc Herniation (DISC-RELIEF)

August 1, 2024 updated by: Foundation University Islamabad

Effects of Physical Therapy on Low Back Pain, Disc Height Index, Postural Stability, Disability, Gait and Function in Persons With Postero-lateral Disc Herniation: The DISC-RELIEF Trial

The current study aims to determine if physical therapy is significantly superior in improving postural stability, pain and function and disc height index in persons with discogenic low back pain, as compared to the standardized medical treatment.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

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 Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan
        • Foundation University Islamabad

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:

  • Both male and female participants
  • Postero-lateral lumbar disc herniation
  • Aged 18-50 years old
  • Low back pain intensity less than 80/100mm on visual analogue scale or 8/10 on numeric pain rating scale
  • Positive peripheralization and centralization phenomenon

Exclusion Criteria:

  • Individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
The Control group will receive standard treatment for the management of discogenic low back pain.
Other: Standard medical treatment
Standard medical treatment
Experimental: Experimental Group
The Physical Therapy group will receive Physical Therapy for the management of discogenic low back pain.
Device: Lumbar Traction
Lumbar traction using traction table
Other: Mckenzie Extension Protocol
Mckenzie Extension Exercises
Device: Interferential Therapy
Interferential Therapy for 20 minutes
Device: Heat Therapy
Heat Therapy for 20 minutes
Other: Sustained Natural Apophyseal Glides (SNAGs)
3-5 reptations of Mulligan's lumbar extension Sustained Natural Apophyseal Glides (SNAGs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Back Pain
Time Frame: 2 weeks
Pain will be measured via Visual Analogue Scale. A higher score signifies poor outcome.
2 weeks
Postural Stability
Time Frame: 2 weeks
Postural Stability will be measured via Biodex Balance System. A higher score signifies poor outcome.
2 weeks
Lumbar Range of Motion
Time Frame: 2 weeks
Lumbar Range of Motion will be measured via inclinometer. A higher score signifies good outcome.
2 weeks
Stride length
Time Frame: 2 weeks
Stride length during gait will be analyzed using observational gait analysis. A greater stride length signifies better outcome
2 weeks
Lumbar Disability
Time Frame: 2 weeks
Lumbar Disability will be measured via Oswestry Disability Index.
2 weeks
Gait Velocity
Time Frame: 2 weeks
Velocity during gait will be analyzed using observational gait analysis. A greater gait velocity signifies better outcome
2 weeks
Cadence
Time Frame: 2 weeks
Cadence during gait will be analyzed using observational gait analysis, which is number of steps per minute.
2 weeks
Disc height index
Time Frame: 2 weeks
Disc height index will be analyzed using Magnetic Resonance Imaging. A greater disc height index signifies better outcome
2 weeks

Collaborators and Investigators

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

Sponsor

Foundation University Islamabad

Investigators

  • Principal Investigator: Muhammad Osama, PhD*, Foundation University Islamabad

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 (Estimated)

August 7, 2024

Primary Completion (Estimated)

February 7, 2025

Study Completion (Estimated)

February 7, 2025

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUI/CTR/2024/16

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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