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

Sponsor

Bayero University Kano, Nigeria (Other)

Overall Status

Completed

CT.gov ID

NCT02901327

Collaborator

(none)

Enrollment

Location

Arms

11.1

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low Back Pain	Procedure: Lumbar Stabilisation Exercise Procedure: treadmill walk exercise	N/A

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 Design

Study Type:

Interventional

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 :

Mar 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

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

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: '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.

Other Names:

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: '5 minutes warm up' at zero degree inclination. '20 minutes active exercise with increasing speed and inclination' '5 minutes cool down'

Other Names:

Aerobic Exercise

Outcome Measures

Primary Outcome Measures

Amplitude of Multifidus Muscle Activation [8 weeks of intervention]
using the surface electromyography

Secondary Outcome Measures

Functional Disability status [Baseline]
using the modified Oswestry disability index questionnaire
Functional Disability status [8 weeks]
using the modified Oswestry disability index questionnaire
Pain Intensity [Baseline]
using the VAS
Pain Intensity [8 weeks]
using the VAS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.