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Multifidus Activation, Pain and Functional Disability in Individuals With Chronic Low Back Pain (CMLBP)

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Lumbar Stabilisation Exercise
treadmill walk exercise
Sponsored by
Bayero University Kano, Nigeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Lumbar Stabilisation Exercise, Treadmill Walk, Multifidus Muscle Activation, Pain Intensity, Functional Disability

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants diagnosed with LBP of mechanical origin and have been present for 3 months or more.
  2. Participants who have a score of at least 20% on Modified Oswestry Dis¬ability Index (ODI).
  3. Participants who gave consent to participate in the study.
  4. Participants who can comprehend instructions in English or Hausa
  5. Participants who are not involved in any other form of exercise training during the course of the study.

Exclusion Criteria:

  1. Patients with history of a prior surgery to the lumbosacral spine.
  2. Patients with any neurological findings indicating radiculopathy.
  3. Patients with very acute symptoms of LBP.
  4. Patients with evidence of systemic disease, carcinoma or organ diseases.
  5. Patients with obesity which due to reduce fatty infiltration that might affect electrical conductivity in the multifidus muscle.
  6. Patients below 18 years of age.

Sites / Locations

  • Aminu Kano Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lumbar Stabilisation Exercise

Treadmill walk exercise

Arm Description

30 minute lumbar stabilization exercise, 3 times per week for 8 weeks.

Walking exercise on a treadmill for a maximum of 30 minutes with increasing speed and inclination. 3 times/week for 8 weeks.

Outcomes

Primary Outcome Measures

Amplitude of Multifidus Muscle Activation
using the surface electromyography

Secondary Outcome Measures

Functional Disability status
using the modified Oswestry disability index questionnaire
Functional Disability status
using the modified Oswestry disability index questionnaire
Pain Intensity
using the VAS
Pain Intensity
using the VAS

Full Information

First Posted
June 9, 2016
Last Updated
September 19, 2016
Sponsor
Bayero University Kano, Nigeria
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1. Study Identification

Unique Protocol Identification Number
NCT02901327
Brief Title
Multifidus Activation, Pain and Functional Disability in Individuals With Chronic Low Back Pain
Acronym
CMLBP
Official Title
Effects of Lumbar Stabilisation Exercise and Treadmill Walk on Multifidus Activation, Pain and Functional Disability in Individuals With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bayero University Kano, Nigeria

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Lumbar Stabilisation Exercise, Treadmill Walk, Multifidus Muscle Activation, Pain Intensity, Functional Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbar Stabilisation Exercise
Arm Type
Experimental
Arm Description
30 minute lumbar stabilization exercise, 3 times per week for 8 weeks.
Arm Title
Treadmill walk exercise
Arm Type
Active Comparator
Arm Description
Walking exercise on a treadmill for a maximum of 30 minutes with increasing speed and inclination. 3 times/week for 8 weeks.
Intervention Type
Procedure
Intervention Name(s)
Lumbar Stabilisation Exercise
Other Intervention Name(s)
Core Exercise
Intervention Description
McGill protocol starting with: 'cat-camel' exercise exercise 10 repetitions with 7 seconds hold each 'curl-up' exercise 10 repetitions with 7 seconds hold each 'side-bridge' exercise 10 repetitions with 7 seconds hold each 'cat-camel' exercise 10 repetitions with 7 seconds hold each progression was based on subjects' tolerance and endurance.
Intervention Type
Procedure
Intervention Name(s)
treadmill walk exercise
Other Intervention Name(s)
Aerobic Exercise
Intervention Description
Bruce protocol This include: '5 minutes warm up' at zero degree inclination. '20 minutes active exercise with increasing speed and inclination' '5 minutes cool down'
Primary Outcome Measure Information:
Title
Amplitude of Multifidus Muscle Activation
Description
using the surface electromyography
Time Frame
8 weeks of intervention
Secondary Outcome Measure Information:
Title
Functional Disability status
Description
using the modified Oswestry disability index questionnaire
Time Frame
Baseline
Title
Functional Disability status
Description
using the modified Oswestry disability index questionnaire
Time Frame
8 weeks
Title
Pain Intensity
Description
using the VAS
Time Frame
Baseline
Title
Pain Intensity
Description
using the VAS
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Aminu Kano Teaching Hospital
City
Kano
ZIP/Postal Code
234777
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
No

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Multifidus Activation, Pain and Functional Disability in Individuals With Chronic Low Back Pain

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