Surface Electromyography in Stratifying Chronic Low Back... | NCT04960358

Studies
Surface Electromyography in Stratifying Chronic Low Back Pain.

NCT04960358

Sponsor

University of Malaya

Status

Completed

Last Update Posted

Jul 13, 2021Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Low Back Pain

Interventions

Surface Electromyography

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2019Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Jul 4, 2021

First Submission Date that Met QC Criteria

Jul 4, 2021

First Posted Date

Jul 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2021

Last Update Posted Date

Jul 13, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chronic LBP		Will be applied Surface Electromyography	Procedure: Surface Electromyography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surface Electromyography	Procedure	will be applied Surface Electromyography to assess Flexion Relaxation Response	Chronic LBP

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ANWAR SUHAIMI, MBBS	University of Malaya	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Malaya Medical Centre		Kuala Lumpur		59100	Malaysia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Dec 29, 2021
Reset	Mar 11, 2022

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 29, 2021			Mar 11, 2022

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

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Browse Branches

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