Clinical trial NCT02901327: Multifidus Activation, Pain and Functional Disability in Individuals With Chronic Low Back Pain
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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Lumbar Stabilisation Exercise
Treadmill Walk
Multifidus Muscle Activation
Pain Intensity
Functional Disability
Lead sponsor: Bayero University Kano, Nigeria
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Amplitude of Multifidus Muscle Activation
timeFrame: 8 weeks of intervention
Secondary outcomes:
measure: Functional Disability status
timeFrame: Baseline
measure: Functional Disability status
timeFrame: 8 weeks
measure: Pain Intensity
timeFrame: Baseline
measure: Pain Intensity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kano
country: Nigeria
facility: Aminu Kano Teaching Hospital
Study officials:
References: