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

NCT06534593 | Enrolling By Invitation

• 1 other identifier: FUI/CTR/2024/16
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Herniation, Disc; Low Back Pain

Outcome Measures

Primary Outcomes (8)

• Back Pain

  Pain will be measured via Visual Analogue Scale. 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

• Postural Stability

  Postural Stability will be measured via Biodex Balance System. A higher score signifies poor outcome.

  2 weeks

• Lumbar Disability

  Lumbar Disability will be measured via Oswestry Disability Index.

  2 weeks

• Stride length

  Stride length during gait will be analyzed using observational gait analysis. A greater stride length signifies better outcome

  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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

The Control group will receive standard treatment for the management of discogenic low back pain.

Other: Standard medical treatment

Experimental Group

EXPERIMENTAL

The Physical Therapy group will receive Physical Therapy for the management of discogenic low back pain.

Device: Lumbar Traction; Other: Mckenzie Extension Protocol; Device: Interferential Therapy; Device: Heat Therapy; Other: Sustained Natural Apophyseal Glides (SNAGs)

Interventions

Standard medical treatment OTHER

Standard medical treatment

Control Group

Lumbar Traction DEVICE

Lumbar traction using traction table

Experimental Group

Mckenzie Extension Protocol OTHER

Mckenzie Extension Exercises

Experimental Group

Interferential Therapy DEVICE

Interferential Therapy for 20 minutes

Experimental Group

Heat Therapy DEVICE

Heat Therapy for 20 minutes

Experimental Group

Sustained Natural Apophyseal Glides (SNAGs) OTHER

3-5 reptations of Mulligan's lumbar extension Sustained Natural Apophyseal Glides (SNAGs)

Experimental Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University Islamabad

Islamabad, Federal, Pakistan

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Low Back Pain

Interventions

Electric Stimulation Therapy; Diathermy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation; Hyperthermia, Induced

Study Officials

• Muhammad Osama, PhD*

  Foundation University Islamabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: the study will consist of 2 arms.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: August 7, 2024
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-07

Locations

PA (1)