NCT04960358

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

1.2 years

First QC Date

July 4, 2021

Last Update Submit

July 4, 2021

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Visual Analog Scale

    1 YEAR

  • Gross Range of Motion

    1 YEAR

Study Arms (1)

Chronic LBP

Will be applied Surface Electromyography

Procedure: Surface Electromyography

Interventions

Surface ElectromyographyPROCEDURE

will be applied Surface Electromyography to assess Flexion Relaxation Response

Chronic LBP

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ANWAR SUHAIMI, MBBS

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 4, 2021

First Posted

July 13, 2021

Study Start

November 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 13, 2021

Record last verified: 2021-07

Locations

MY(1)