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)

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: Low Back Pain; Herniation, Disc
• Intervention / Treatment: Other: Standard medical treatment; Device: Lumbar Traction; Other: Mckenzie Extension Protocol; Device: Interferential Therapy; Device: Heat Therapy; Other: Sustained Natural Apophyseal Glides (SNAGs)

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

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

Study record dates

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: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Hernia; Intervertebral Disc Displacement
• 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