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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05326594
Other study ID # FUI/CTR/2022/5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date June 30, 2023

Study information

Verified date February 2024
Source Foundation University Islamabad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Months to 50 Years
Eligibility 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 Design


Intervention

Procedure:
Mckenzie Extension Protocol
Mckenzie Extension Exercise Protocol will be performed by participants in prone position
Lumbar SNAGs
Lumbar SNAGs will be performed in lumbar flexion and extension in standing Position
Device:
Inferential therapy
4 pole inferential therapy in combination with superficial heating for 20 minutes
Procedure:
Heat Therapy
superficial heating for 20 minutes

Locations

Country Name City State
Pakistan Foundation University Islamabad Islamabad

Sponsors (1)

Lead Sponsor Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Back Pain Pain will be measured via Visual Analogue Scale. A higher score signifies poor outcome. 2 weeks
Primary Lumbar Range of Motion Lumbar Range of Motion will be measured via inclinometer. A higher score signifies good outcome. 2 weeks
Primary Postural Stability Postural Stability will be measured via Biodex Balance System. A higher score signifies poor outcome. 2 weeks
Primary Lumbar Disability Disability will be measured via Oswestry Disability Index. 2 weeks
Primary Step length Step length during gait will be analyzed using observational gait analysis. A greater step length signifies better outcome 2 weeks
Primary Stride length Stride length during gait will be analyzed using observational gait analysis. A greater stride length signifies better outcome 2 weeks
Primary Gait velocity Velocity during gait will be analyzed using observational gait analysis. A greater gait velocity signifies better outcome 2 weeks
Primary Disc Height Disc will be analyzed using Magnetic Resonance Imaging 2 weeks
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