Back to resultsEffects of Physical Therapy on Improving Disc Height, Postural Stability, Pain and Function in Persons With Discogenic Low Back Pain
Primary Purpose
Low Back Pain, Disk Prolapse
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mckenzie Extension Protocol
Lumbar SNAGs
Inferential therapy
Heat Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physical Therapy
Arm Description
Outcomes
Primary Outcome Measures
Back Pain
Pain will be measured via Visual Analogue Scale. A higher score signifies poor outcome.
Lumbar Range of Motion
Lumbar Range of Motion will be measured via inclinometer. A higher score signifies good outcome.
Postural Stability
Postural Stability will be measured via Biodex Balance System. A higher score signifies poor outcome.
Lumbar Disability
Disability will be measured via Oswestry Disability Index.
Step length
Step length during gait will be analyzed using observational gait analysis. A greater step length signifies better outcome
Stride length
Stride length during gait will be analyzed using observational gait analysis. A greater stride length signifies better outcome
Gait velocity
Velocity during gait will be analyzed using observational gait analysis. A greater gait velocity signifies better outcome
Disc Height
Disc will be analyzed using Magnetic Resonance Imaging
Secondary Outcome Measures
Full Information
NCT ID
NCT05326594
First Posted
March 29, 2022
Last Updated
April 6, 2022
Sponsor
Foundation University Islamabad
1. Study Identification
Unique Protocol Identification Number
NCT05326594
Brief Title
Effects of Physical Therapy on Improving Disc Height, Postural Stability, Pain and Function in Persons With Discogenic Low Back Pain
Official Title
Effects of Physical Therapy on Improving Disc Height, Postural Stability, Pain and Function in Persons With Discogenic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Disk Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physical Therapy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Mckenzie Extension Protocol
Intervention Description
Mckenzie Extension Exercise Protocol will be performed by participants in prone position
Intervention Type
Procedure
Intervention Name(s)
Lumbar SNAGs
Intervention Description
Lumbar SNAGs will be performed in lumbar flexion and extension in standing Position
Intervention Type
Device
Intervention Name(s)
Inferential therapy
Intervention Description
4 pole inferential therapy in combination with superficial heating for 20 minutes
Intervention Type
Procedure
Intervention Name(s)
Heat Therapy
Intervention Description
superficial heating for 20 minutes
Primary Outcome Measure Information:
Title
Back Pain
Description
Pain will be measured via Visual Analogue Scale. A higher score signifies poor outcome.
Time Frame
2 weeks
Title
Lumbar Range of Motion
Description
Lumbar Range of Motion will be measured via inclinometer. A higher score signifies good outcome.
Time Frame
2 weeks
Title
Postural Stability
Description
Postural Stability will be measured via Biodex Balance System. A higher score signifies poor outcome.
Time Frame
2 weeks
Title
Lumbar Disability
Description
Disability will be measured via Oswestry Disability Index.
Time Frame
2 weeks
Title
Step length
Description
Step length during gait will be analyzed using observational gait analysis. A greater step length signifies better outcome
Time Frame
2 weeks
Title
Stride length
Description
Stride length during gait will be analyzed using observational gait analysis. A greater stride length signifies better outcome
Time Frame
2 weeks
Title
Gait velocity
Description
Velocity during gait will be analyzed using observational gait analysis. A greater gait velocity signifies better outcome
Time Frame
2 weeks
Title
Disc Height
Description
Disc will be analyzed using Magnetic Resonance Imaging
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Osama, PhD*
Phone
+923325540436
Email
osama@fui.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Osama, PhD*
Organizational Affiliation
FUI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aamer Naeem, PhD*
Organizational Affiliation
FUI
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Physical Therapy on Improving Disc Height, Postural Stability, Pain and Function in Persons With Discogenic Low Back Pain
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