Chronic Low Back PainCMLBPNCT02901327
Multifidus Activation, Pain and Functional Disability in Individuals With Chronic Low Back Pain
A study testing Lumbar Stabilisation Exercise and treadmill walk exercise in people with Chronic Low Back Pain, run by Bayero University Kano, Nigeria at 1 site in Nigeria.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Lumbar Stabilisation Exercise and treadmill walk exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteNigeria
- Study dates
- Mar 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Lumbar Stabilisation Exercise and Treadmill Walk on 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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Lumbar Stabilisation Exercise, treadmill walk exercise
- Keywords
- Lumbar Stabilisation Exercise, Treadmill Walk, Multifidus Muscle Activation, Pain Intensity, Functional Disability
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Stabilisation ExerciseProcedure or surgery
Also called Core 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 exerciseProcedure or surgery
Also called Aerobic 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'
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Stabilisation Exercise | Experimental | 30 minute lumbar stabilization exercise, 3 times per week for 8 weeks. Receives: 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. Receives: Procedure: treadmill walk exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of Multifidus Muscle Activation
using the surface electromyography
Measured: 8 weeks of intervention
Secondary outcomes (4)
Functional Disability status
using the modified Oswestry disability index questionnaire
Measured: Baseline
Functional Disability status
using the modified Oswestry disability index questionnaire
Measured: 8 weeks
Pain Intensity
using the VAS
Measured: Baseline
Pain Intensity
using the VAS
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayero University Kano, Nigeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BASHIR BELLO, Bayero University Kano, Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901327
- Sponsor's protocol ID
- BayeroUK
- Acronym
- CMLBP
- Status last verified
- Sep 2016
- First submitted
- 9 Jun 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lumbar Stabilisation Exercise and Treadmill Walk on Multifidus Activation, Pain and Functional Disability in Individuals With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02901327
- Acronym / sponsor ID
- CMLBP / BayeroUK
- Conditions
- Chronic Low Back Pain
- Keywords
- Lumbar Stabilisation Exercise, Treadmill Walk, Multifidus Muscle Activation, Pain Intensity, Functional Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Bayero University Kano, NigeriaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar Stabilisation Exercise | Experimental | Procedure: Lumbar Stabilisation Exercise30 minute lumbar stabilization exercise, 3 times per week for 8 weeks. |
| Treadmill walk exercise | Active comparator | Procedure: treadmill walk exerciseWalking exercise on a treadmill for a maximum of 30 minutes with increasing speed and inclination. 3 times/week for 8 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar Stabilisation ExerciseAlso: Core ExerciseMcGill 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. | Procedure or surgery | Lumbar Stabilisation Exercise |
| treadmill walk exerciseAlso: Aerobic ExerciseBruce 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' | Procedure or surgery | Treadmill walk exercise |
Primary outcome
Amplitude of Multifidus Muscle Activation
Time frame: 8 weeks of intervention
using the surface electromyography
4 secondary outcomes
Functional Disability status
Time frame: Baseline
Functional Disability status
Time frame: 8 weeks
Pain Intensity
Time frame: Baseline
Pain Intensity
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Stabilisation Exercise and treadmill walk exercise in people with Chronic Low Back Pain, run by Bayero University Kano, Nigeria at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of Multifidus Muscle Activation (time frame: 8 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.