- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05326594
Effects of Physical Therapy on Improving Disc Height, Postural Stability, Pain and Function in Persons With Discogenic Low Back Pain
February 26, 2024 updated by: Foundation University Islamabad
Effects of Physical Therapy on Improving Disc Height Index, Postural Stability, Pain and Function in Persons With Discogenic Low Back Pain
Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition, however there is no conclusive evidence regarding the positive effects of conservative physical therapy management in terms of radiological changes and improvement in disc height.
For this reason, the current study will not only look into the positive effects of conservative physical therapy on postural stability, pain and function, but also in terms of disc height in persons with discogenic low back pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
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
-
-
-
Islamabad, Pakistan, 66000
- 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
1 year to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Both male and female participants
- Aged 18-50 years old
- low back pain intensity less than 80/100mm on visual analogue scale
- positive centralization phenomenon
- low signal intensity of IV disc on T2 - weighted MRI
- high intensity zone towards the posterior aspect of the disc on MRI
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physical Therapy
|
Mckenzie Extension Exercise Protocol will be performed by participants in prone position
Lumbar SNAGs will be performed in lumbar flexion and extension in standing Position
4 pole inferential therapy in combination with superficial heating for 20 minutes
superficial heating for 20 minutes
|
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 Disability
Time Frame: 2 weeks
|
Disability will be measured via Oswestry Disability Index.
|
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
|
|
Step length
Time Frame: 2 weeks
|
Step length during gait will be analyzed using observational gait analysis.
A greater step length signifies better 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
|
|
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
|
|
Disc Height
Time Frame: 2 weeks
|
Disc will be analyzed using Magnetic Resonance Imaging
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Muhammad Osama, PhD*, FUI
- Principal Investigator: Aamer Naeem, PhD*, FUI
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)
May 1, 2022
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
March 29, 2022
First Submitted That Met QC Criteria
April 6, 2022
First Posted (Actual)
April 13, 2022
Study Record Updates
Last Update Posted (Estimated)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 26, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2022/5
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.