- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02901327
Multifidus Activation, Pain and Functional Disability in Individuals With Chronic Low Back Pain (CMLBP)
September 19, 2016 updated by: BASHIR BELLO, Bayero University Kano, Nigeria
Effects of Lumbar Stabilisation Exercise and Treadmill Walk on Multifidus Activation, Pain and Functional Disability in Individuals With Chronic Low Back Pain
Chronic Mechanical Low Back Pain (CMLBP) is a common disabling health problem among the general population.
Multifidus muscle inhibition accompanying CMLBP plays a major role in perpetuating the pain and functional disability.
Lumbar stabilisation and treadmill exercises are established treatments for CMLBP.
However, it is not known which of the two techniques is more effective.
This study was conducted to compare the effects of lumbar stabilisation and treadmill walk on multifidus activation, pain and functional disability in individuals with CMLBP.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Fifty-three individuals (23 females and 30 males) with CMLBP participated in this single blind randomised clinical trial.
Consecutive participants were recruited from the outpatient Physiotherapy clinic of the Aminu Kano Teaching Hospital, Kano, Nigeria and were randomly assigned to one of two exercise groups: Lumbar Stabilisation Group (LSG; n = 27) or Treadmill Walk Group (TWG; n = 26).
However, 50 participants, (LSG: n = 25; and TWG: n = 25) completed the eight week study.
Participants in the LSG had lumbar stabilisation exercises using McGill protocol while those in the TWG had walking exercise on a treadmill using the Bruce protocol.
Treatment was applied three times weekly for eight weeks.
Outcomes assessed at baseline and end of eighth week of study were: Pain Intensity (PI) using Visual Analogue scale, Functional Disability (FD) using Oswestry Disability Index Questionnaire; and Multifidus Muscle Activation (MMA) level using a surface electromyography machine.
Data were analysed using descriptive statistics, paired and independent t-tests at α0.05.
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kano, Nigeria, 234777
- Aminu Kano Teaching Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants diagnosed with LBP of mechanical origin and have been present for 3 months or more.
- Participants who have a score of at least 20% on Modified Oswestry Dis¬ability Index (ODI).
- Participants who gave consent to participate in the study.
- Participants who can comprehend instructions in English or Hausa
- Participants who are not involved in any other form of exercise training during the course of the study.
Exclusion Criteria:
- Patients with history of a prior surgery to the lumbosacral spine.
- Patients with any neurological findings indicating radiculopathy.
- Patients with very acute symptoms of LBP.
- Patients with evidence of systemic disease, carcinoma or organ diseases.
- Patients with obesity which due to reduce fatty infiltration that might affect electrical conductivity in the multifidus muscle.
- Patients below 18 years of age.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lumbar Stabilisation Exercise
30 minute lumbar stabilization exercise, 3 times per week for 8 weeks.
|
McGill protocol starting with:
Other Names:
|
|
Active Comparator: Treadmill walk exercise
Walking exercise on a treadmill for a maximum of 30 minutes with increasing speed and inclination.
3 times/week for 8 weeks.
|
Bruce protocol This include:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amplitude of Multifidus Muscle Activation
Time Frame: 8 weeks of intervention
|
using the surface electromyography
|
8 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Disability status
Time Frame: Baseline
|
using the modified Oswestry disability index questionnaire
|
Baseline
|
|
Functional Disability status
Time Frame: 8 weeks
|
using the modified Oswestry disability index questionnaire
|
8 weeks
|
|
Pain Intensity
Time Frame: Baseline
|
using the VAS
|
Baseline
|
|
Pain Intensity
Time Frame: 8 weeks
|
using the VAS
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
June 9, 2016
First Submitted That Met QC Criteria
September 14, 2016
First Posted (Estimate)
September 15, 2016
Study Record Updates
Last Update Posted (Estimate)
September 20, 2016
Last Update Submitted That Met QC Criteria
September 19, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BayeroUK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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