Low Back PainNCT04960358
Surface Electromyography in Stratifying Chronic Low Back Pain.
An observational study of Low Back Pain, run by University of Malaya at 1 site in Malaysia.
Trial summary
Surface Electromyography can be utilised to detect normal muscle electrical activity during maximum forward flexion termed Flexion Relaxation Response (FRR) Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Surface Electromyography
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Nov 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Surface Electromyography
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface ElectromyographyProcedure or surgery
will be applied Surface Electromyography to assess Flexion Relaxation Response
| Study group | Role | What they receive |
|---|---|---|
| Chronic LBP | Will be applied Surface Electromyography Receives: Procedure: Surface Electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Low Back Pain Disability Questionnaire
Questionnaire of the functional assessment for the low back pain patient
Measured: 1 YEAR
Flexion Relaxation Response (FRR) ratio
The FRR ratio was calculated from the best SEMG values obtained during Forward Lumbar Flexion \& Extension
Measured: 1 YEAR
Secondary outcomes (2)
Visual Analog Scale
Representing range of pain intensity from no pain on the far left to most intense pain on the far right.
Measured: 1 YEAR
Gross Range of Motion
Degree of trunk motion at maximum voluntary flexion, measured by inclinometer at the level of T12
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Nov 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anwar Suhaimi, University of Malaya
- Investigators
- ANWAR SUHAIMI, MBBS, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960358
- Sponsor's protocol ID
- 201948-7312
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application Of Surface Electromyography (SEMG) In Stratifying Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04960358
- Acronym / sponsor ID
- 201948-7312
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic LBP | – | Procedure: Surface ElectromyographyWill be applied Surface Electromyography |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surface Electromyographywill be applied Surface Electromyography to assess Flexion Relaxation Response | Procedure or surgery | Chronic LBP |
Primary outcome
Oswestry Low Back Pain Disability Questionnaire
Time frame: 1 YEAR
Questionnaire of the functional assessment for the low back pain patient
Flexion Relaxation Response (FRR) ratio
Time frame: 1 YEAR
The FRR ratio was calculated from the best SEMG values obtained during Forward Lumbar Flexion \& Extension
2 secondary outcomes
Visual Analog Scale
Time frame: 1 YEAR
Gross Range of Motion
Time frame: 1 YEAR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANWAR SUHAIMI, MBBS principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Low Back Pain Disability Questionnaire (time frame: 1 YEAR). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.