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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02901327
Other study ID # BayeroUK
Secondary ID
Status Completed
Phase N/A
First received June 9, 2016
Last updated September 19, 2016
Start date March 2015
Est. completion date February 2016

Study information

Verified date September 2016
Source Bayer University Kano, Nigeria
Contact n/a
Is FDA regulated No
Health authority Nigeria: Federal Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date February 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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'

Locations

Country Name City State
Nigeria Aminu Kano Teaching Hospital Kano

Sponsors (1)

Lead Sponsor Collaborator
Bayer University Kano, Nigeria

Country where clinical trial is conducted

Nigeria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Amplitude of Multifidus Muscle Activation using the surface electromyography 8 weeks of intervention Yes
Secondary Functional Disability status using the modified Oswestry disability index questionnaire Baseline Yes
Secondary Functional Disability status using the modified Oswestry disability index questionnaire 8 weeks Yes
Secondary Pain Intensity using the VAS Baseline Yes
Secondary Pain Intensity using the VAS 8 weeks Yes
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