NCT02901327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

June 9, 2016

Last Update Submit

September 19, 2016

Conditions

Chronic Low Back Pain

Keywords

Lumbar Stabilisation ExerciseTreadmill WalkMultifidus Muscle ActivationPain IntensityFunctional Disability

Outcome Measures

Primary Outcomes (1)

  • Amplitude of Multifidus Muscle Activation

    using the surface electromyography

    8 weeks of intervention

Secondary Outcomes (4)

  • Functional Disability status

    Baseline

  • Functional Disability status

    8 weeks

  • Pain Intensity

    Baseline

  • Pain Intensity

    8 weeks

Study Arms (2)

Lumbar Stabilisation Exercise

EXPERIMENTAL

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

Procedure: Lumbar Stabilisation Exercise

Treadmill walk exercise

ACTIVE COMPARATOR

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

Interventions

Lumbar Stabilisation ExercisePROCEDURE

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.

Also known as: Core Exercise
Lumbar Stabilisation Exercise
treadmill walk exercisePROCEDURE

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'

Also known as: Aerobic Exercise
Treadmill walk exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aminu Kano Teaching Hospital

Kano, Kano State, 234777, Nigeria

Location

MeSH Terms

Conditions

Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 9, 2016

First Posted

September 15, 2016

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

September 20, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

NG(1)