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Completed

NCT Number: NCT02901327

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

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.

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Key information

Conditions

Chronic Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aminu Kano Teaching Hospital

Kano, Kano State, 234777, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lumbar Stabilisation Exercise

Procedure

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

treadmill walk exercise

Procedure

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

Primary outcomes

  1. Amplitude of Multifidus Muscle Activation

    Time frame: 8 weeks of intervention

    using the surface electromyography

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayero University Kano, Nigeria

Other

Registry information

Official study title

Effects of Lumbar Stabilisation Exercise and Treadmill Walk on Multifidus Activation, Pain and Functional Disability in Individuals With Chronic Low Back Pain

Acronym: CMLBP

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 15, 2016
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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