Surface Electromyography in Stratifying Chronic Low Back Pain.

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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with low back pain who were being referred to the rehabilitation outpatient in University Malaya Medical Centre between November 2019 until July 2020.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Gross Range of Motion	Degree of trunk motion at maximum voluntary flexion, measured by inclinometer at the level of T12	1 YEAR

Collaborators and Investigators

• Sponsor: University of Malaya

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 201948-7312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No