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NCT04960358 Clinical Trial

Surface Electromyography in Stratifying Chronic Low Back Pain.

Low Back Pain Clinical Trial

Official title:
The Application Of Surface Electromyography (SEMG) In Stratifying Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04960358
Other study ID # 201948-7312
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date December 31, 2020

Study information
Verified date July 2021
Source University of Malaya
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Surface Electromyography can be utilised to detect normal muscle electrical activity during maximum forward flexion termed Flexion Relaxation Response (FRR)

Description:

In this study, our primary objective is to assess FRR and disability (ODI) correlation protocol as an objective tool in stratifying Chronic LBP. We also would like to evaluate the relationship between FRR with pain intensity and lumbar range of motion as our secondary objective.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: - Participants aged between 20 - 70 years old - Mechanical LBP > 6 weeks (not acute LBP) - Not received any specific exercise spinal manipulation or surgery to improve LBP within the last 3 months. Exclusion Criteria: - Pregnancy - Radicular LBP patients or specific-spinal pathology / "red-flags". - Surgical intervention for the current LBP complaint (includes traumatic causes of LBP with surgical intervention) - Cognitive or communication difficulty preventing active participation in exercises or communicating pain scores

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Surface Electromyography
will be applied Surface Electromyography to assess Flexion Relaxation Response

Locations
Country Name City State
Malaysia University Malaya Medical Centre Kuala Lumpur

Sponsors (1)
Lead Sponsor Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oswestry Low Back Pain Disability Questionnaire Questionnaire of the functional assessment for the low back pain patient 1 YEAR
Primary Flexion Relaxation Response (FRR) ratio The FRR ratio was calculated from the best SEMG values obtained during Forward Lumbar Flexion & Extension 1 YEAR
Secondary Visual Analog Scale Representing range of pain intensity from no pain on the far left to most intense pain on the far right. 1 YEAR
Secondary Gross Range of Motion Degree of trunk motion at maximum voluntary flexion, measured by inclinometer at the level of T12 1 YEAR
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