Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02901327
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
BASHIR BELLO, Bayero University Kano, Nigeria

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Procedure: Lumbar Stabilisation Exercise Procedure: treadmill walk exercise Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lumbar Stabilisation Exercise
30 minute lumbar stabilization exercise, 3 times per week for 8 weeks.
Procedure: Lumbar Stabilisation Exercise

McGill protocol starting with:

  1. 'cat-camel' exercise exercise 10 repetitions with 7 seconds hold each
  2. 'curl-up' exercise 10 repetitions with 7 seconds hold each
  3. 'side-bridge' exercise 10 repetitions with 7 seconds hold each
  4. 'cat-camel' exercise 10 repetitions with 7 seconds hold each progression was based on subjects' tolerance and endurance.
Other Name: Core Exercise

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.
Procedure: treadmill walk exercise

Bruce protocol

This include:

  1. '5 minutes warm up' at zero degree inclination.
  2. '20 minutes active exercise with increasing speed and inclination'
  3. '5 minutes cool down'
Other Name: Aerobic Exercise




Primary Outcome Measures :
  1. Amplitude of Multifidus Muscle Activation [ Time Frame: 8 weeks of intervention ]
    using the surface electromyography


Secondary Outcome Measures :
  1. Functional Disability status [ Time Frame: Baseline ]
    using the modified Oswestry disability index questionnaire

  2. Functional Disability status [ Time Frame: 8 weeks ]
    using the modified Oswestry disability index questionnaire

  3. Pain Intensity [ Time Frame: Baseline ]
    using the VAS

  4. Pain Intensity [ Time Frame: 8 weeks ]
    using the VAS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901327


Locations
Layout table for location information
Nigeria
Aminu Kano Teaching Hospital
Kano, Nigeria, 234777
Sponsors and Collaborators
Bayero University Kano, Nigeria

Layout table for additonal information
Responsible Party: BASHIR BELLO, Dr., Bayero University Kano, Nigeria
ClinicalTrials.gov Identifier: NCT02901327     History of Changes
Other Study ID Numbers: BayeroUK
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by BASHIR BELLO, Bayero University Kano, Nigeria:
Lumbar Stabilisation Exercise
Treadmill Walk
Multifidus Muscle Activation
Pain Intensity
Functional Disability
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms