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

NCT ID: NCT02901327

Last Updated: 2016-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-02-29

Brief Summary

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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

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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.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lumbar Stabilisation Exercise

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

Group Type EXPERIMENTAL

Lumbar Stabilisation Exercise

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

treadmill walk exercise

Intervention Type PROCEDURE

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'

Interventions

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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.

Intervention Type 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'

Intervention Type PROCEDURE

Other Intervention Names

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Core Exercise Aerobic Exercise

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayero University Kano, Nigeria

OTHER

Sponsor Role lead

Responsible Party

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BASHIR BELLO

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aminu Kano Teaching Hospital

Kano, Kano State, Nigeria

Site Status

Countries

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Nigeria

Other Identifiers

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BayeroUK

Identifier Type: -

Identifier Source: org_study_id

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