Surface Electromyography in Stratifying Chronic Low Back Pain.

Sponsor

University of Malaya (Other)

Overall Status

Completed

CT.gov ID

NCT04960358

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Procedure: Surface Electromyography

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Nov 1, 2019

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Chronic LBP Will be applied Surface Electromyography	Procedure: Surface Electromyography will be applied Surface Electromyography to assess Flexion Relaxation Response

Arm

Intervention/Treatment

Chronic LBP

Will be applied Surface Electromyography

Procedure: Surface Electromyography

will be applied Surface Electromyography to assess Flexion Relaxation Response

Outcome Measures

Primary Outcome Measures

Oswestry Low Back Pain Disability Questionnaire [1 YEAR]
Questionnaire of the functional assessment for the low back pain patient
Flexion Relaxation Response (FRR) ratio [1 YEAR]
The FRR ratio was calculated from the best SEMG values obtained during Forward Lumbar Flexion & Extension

Secondary Outcome Measures

Visual Analog Scale [1 YEAR]
Representing range of pain intensity from no pain on the far left to most intense pain on the far right.
Gross Range of Motion [1 YEAR]
Degree of trunk motion at maximum voluntary flexion, measured by inclinometer at the level of T12

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Malaya Medical Centre	Kuala Lumpur		Malaysia	59100

Sponsors and Collaborators

University of Malaya

Investigators

Principal Investigator: ANWAR SUHAIMI, MBBS, University of Malaya

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Anwar Suhaimi, Dr, University of Malaya

ClinicalTrials.gov Identifier:

NCT04960358

Other Study ID Numbers:

201948-7312

First Posted:

Jul 13, 2021

Last Update Posted:

Jul 13, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of Jul 13, 2021