Chronic Low Back PainNCT03398174
A Pilot Study of Motor Control Exercise and Patient Education for the Management of Chronic Low Back Pain in Rural Nigerian Community.
A study testing Patient Education in people with Chronic Low Back Pain, run by Bayero University Kano, Nigeria at 1 site in Nigeria.
Trial summary
The main purpose of this pilot single-blind randomized clinical trial is to assess the feasibility of implementing motor control exercise and patient education for the management of chronic low back pain (CLBP) in a low resource rural Nigerian community. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNigeria
- Study dates
- 20 Jan 2018to 1 May 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female between 18 and 65 years old.
- Primary complaint of LBP experienced at least over the previous 3-month duration.
- Ability to read/understand English or Hausa language.
Who cannot join
- Previous history of thoracic spine or lumbosacral spine surgery.
- Any neurological findings indicating radiculopathy.
- Evidence of serious spine pathology (e.g. tumor, infection, fracture, spinal stenosis, inflammatory disease).
- Unstable or severe disabling chronic cardiovascular and pulmonary disease.
- History of serious psychological or psychiatric illness.
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motor Control Exercise and Patient Education for the Management of Chronic Low Back Pain in a Low-Resource Rural Nigerian Community: A Pilot Randomized Controlled Trial.
The main purpose of this pilot single-blind randomized clinical trial is to assess the feasibility of implementing motor control exercise and patient education for the management of chronic low back pain (CLBP) in a low resource rural Nigerian community.
Read the detailed description
This study will determine whether supervised exercise training emphasizing motor control exercise (MCE) approach and a designed patient education (PE) program based on the psychosocial approach will be feasible and acceptable in reducing pain intensity and functional disability among rural dwellers with CLBP in Nigeria.
Participants will be recruited and assigned to one of three intervention groups that include MCE group, PE group, or MCE plus PE gr using a simple random technique based on an electronic randomization table generated by a computer software program. Blinded assessment of all clinical outcomes will be performed at baseline and 6 weeks after randomization.
Primary outcomes include pain intensity and functional disability while secondary outcomes include overall treatment satisfaction.
Data will be analyzed using descriptive statistics, paired t-test, and ANOVA. All statistical analyses will be performed on SPSS (version 24.00) at an alpha level of 0.05.
- Conditions
- Chronic Low Back Pain
- Being tested
- Motor Control Exercise, Patient Education
- Keywords
- Rural dwellers, Patient Education, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Control ExerciseBehavioural
Also called Specific Stabilisation Exercise
Exercise aiming at improving function of specific muscles of the lumbopelvic region and the control of posture and movement.
In addition, participants will perform stretching exercises aiming at targeting the postural muscles and connective tissue around the lower back, pelvis and lower limb that tend to get shortened in chronic LBP, and they will be advised to perform aerobic exercise in the form of overground walking at desirable speed at home.
Patient EducationBehavioural
Also called Psychosocial Education
Patient education to enable patients to better understand their pain, change any unhelpful beliefs about LBP, and integrate self-management and active coping strategies that deals with fear avoidance behavior and catastrophic thought.
In addition, participants will perform stretching exercises aiming at targeting the postural muscles and connective tissue around the lower back, pelvis and lower limb that tend to get shortened in chronic LBP, and they will be advised to perform aerobic exercise in the form of overground walking at desirable speed at home.
| Study group | Role | What they receive |
|---|---|---|
| Motor Control Exercise Plus Patient Education | Experimental | Participants will receive a total of 12 sessions (2 sessions per week) of exercise program consisting of motor control training and group patient education session once a week (6 sessions) all over 6-weeks.
The motor control training will be aiming at improving function of specific muscles of the lumbopelvic region and the control of posture and movement.
The patient education program will be aiming to provide non-threatening information to enable patients to better understand their pain, change any unhelpful beliefs about LBP, and integrate self-management and active coping strategies that deals with fear avoidance behavior and catastrophic thought.
In addition, participants will also perform stretching exercises and instructed to perform continuous overground walk. Receives: Behavioral: Motor Control Exercise; Behavioral: Patient Education |
| Motor Control Exercise | Experimental | Participants will receive the same motor control exercise program described in the patient education and motor control exercise group.
In addition, participants will also perform stretching exercises and instructed to perform continuous overground walk. Receives: Behavioral: Motor Control Exercise |
| Patient Education | Experimental | Participants will receive the same patient education program described in the motor control exercise plus patient education group.
In addition, participants will also perform stretching exercises and instructed to perform continuous overground walk. Receives: Behavioral: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain Intensity
Pain Intensity will be measured by an 11-point (0-10) Numerical Pain Rating Scale (NPRS).
Measured: Baseline and 6 weeks after beginning treatment.
Change in functional disability
Functional disability will be measured by Oswestry disability index (ODI). The questionnaire consists of 10 items with each item having six statements. All scores are summed, then multiplied by two to obtain the index (range 0 to 100) with higher score indicating greater disability.
Measured: Baseline and 6 weeks after beginning treatment.
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction with treatment will be assessed using a 5-point Likert scale ranging from "very dissatisfied" (0) to "very satisfied" (4), with higher scores reflecting greater satisfaction.
Measured: 6 weeks after beginning treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start20 Jan 2018
- Primary completion30 Apr 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayero University Kano, Nigeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aminu A. Ibrahim, Bayero University Kano, Nigeria
- Investigators
- Aminu A Ibrahim, BPT, MPT, Principal investigator, Physiotherapy Department, Faculty of Allied Health Sciences, Bayero University, Kano. Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398174
- Sponsor's protocol ID
- SPS/PPT/15/00009
- Status last verified
- Nov 2018
- First submitted
- 6 Jan 2018
- Last updated
- 15 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ibrahim AA, Akindele MO, Ganiyu SO. Motor control exercise and patient education program for low resource rural community dwelling adults with chronic low back pain: a pilot randomized clinical trial. J Exerc Rehabil. 2018 Oct 31;14(5):851-863. doi: 10.12965/jer.1836348.174. eCollection 2018 Oct.
PubMed 30443533
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Control Exercise and Patient Education for the Management of Chronic Low Back Pain in a Low-Resource Rural Nigerian Community: A Pilot Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03398174
- Acronym / sponsor ID
- SPS/PPT/15/00009
- Conditions
- Chronic Low Back Pain
- Keywords
- Rural dwellers, Patient Education, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bayero University Kano, NigeriaUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 12 Jan 2018 (actual)
- 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.
The main purpose of this pilot single-blind randomized clinical trial is to assess the feasibility of implementing motor control exercise and patient education for the management of chronic low back pain (CLBP) in a low resource rural Nigerian community.
Detailed description
This study will determine whether supervised exercise training emphasizing motor control exercise (MCE) approach and a designed patient education (PE) program based on the psychosocial approach will be feasible and acceptable in reducing pain intensity and functional disability among rural dwellers with CLBP in Nigeria.
Participants will be recruited and assigned to one of three intervention groups that include MCE group, PE group, or MCE plus PE gr using a simple random technique based on an electronic randomization table generated by a computer software program. Blinded assessment of all clinical outcomes will be performed at baseline and 6 weeks after randomization.
Primary outcomes include pain intensity and functional disability while secondary outcomes include overall treatment satisfaction.
Data will be analyzed using descriptive statistics, paired t-test, and ANOVA. All statistical analyses will be performed on SPSS (version 24.00) at an alpha level of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motor Control Exercise Plus Patient Education | Experimental | Behavioral: Motor Control Exercise, Behavioral: Patient EducationParticipants will receive a total of 12 sessions (2 sessions per week) of exercise program consisting of motor control training and group patient education session once a week (6 sessions) all over 6-weeks. The motor control training will be aiming at improving function of specific muscles of the lumbopelvic region and the control of posture and movement. The patient education program will be aiming to provide non-threatening information to enable patients to better understand their pain, change any unhelpful beliefs about LBP, and integrate self-management and active coping strategies that deals with fear avoidance behavior and catastrophic thought. In addition, participants will also perform stretching exercises and instructed to perform continuous overground walk. |
| Motor Control Exercise | Experimental | Behavioral: Motor Control ExerciseParticipants will receive the same motor control exercise program described in the patient education and motor control exercise group. In addition, participants will also perform stretching exercises and instructed to perform continuous overground walk. |
| Patient Education | Experimental | Behavioral: Patient EducationParticipants will receive the same patient education program described in the motor control exercise plus patient education group. In addition, participants will also perform stretching exercises and instructed to perform continuous overground walk. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female between 18 and 65 years old.
- Primary complaint of LBP experienced at least over the previous 3-month duration.
- Ability to read/understand English or Hausa language.
Key exclusion criteria (6 listed)
- Previous history of thoracic spine or lumbosacral spine surgery.
- Any neurological findings indicating radiculopathy.
- Evidence of serious spine pathology (e.g. tumor, infection, fracture, spinal stenosis, inflammatory disease).
- Unstable or severe disabling chronic cardiovascular and pulmonary disease.
- History of serious psychological or psychiatric illness.
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 |
|---|---|---|
| Motor Control ExerciseAlso: Specific Stabilisation ExerciseExercise aiming at improving function of specific muscles of the lumbopelvic region and the control of posture and movement. In addition, participants will perform stretching exercises aiming at targeting the postural muscles and connective tissue around the lower back, pelvis and lower limb that tend to get shortened in chronic LBP, and they will be advised to perform aerobic exercise in the form of overground walking at desirable speed at home. | Behavioural | Motor Control Exercise, Motor Control Exercise Plus Patient Education |
| Patient EducationAlso: Psychosocial EducationPatient education to enable patients to better understand their pain, change any unhelpful beliefs about LBP, and integrate self-management and active coping strategies that deals with fear avoidance behavior and catastrophic thought. In addition, participants will perform stretching exercises aiming at targeting the postural muscles and connective tissue around the lower back, pelvis and lower limb that tend to get shortened in chronic LBP, and they will be advised to perform aerobic exercise in the form of overground walking at desirable speed at home. | Behavioural | Motor Control Exercise Plus Patient Education, Patient Education |
Primary outcome
Change in pain Intensity
Time frame: Baseline and 6 weeks after beginning treatment.
Pain Intensity will be measured by an 11-point (0-10) Numerical Pain Rating Scale (NPRS).
Change in functional disability
Time frame: Baseline and 6 weeks after beginning treatment.
Functional disability will be measured by Oswestry disability index (ODI). The questionnaire consists of 10 items with each item having six statements. All scores are summed, then multiplied by two to obtain the index (range 0 to 100) with higher score indicating greater disability.
1 secondary outcome
Patient satisfaction
Time frame: 6 weeks after beginning treatment.
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 15 Nov 2018.
- Derived from this study: PubMed 30443533Ibrahim AA, Akindele MO, Ganiyu SO. Motor control exercise and patient education program for low resource rural community dwelling adults with chronic low back pain: a pilot randomized clinical trial. J Exerc Rehabil. 2018 Oct 31;14(5):851-863. doi: 10.12965/jer.1836348.174. eCollection 2018 Oct.
- Individual participant dataSharing planned: Undecided
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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.
Aminu A Ibrahim, BPT, MPT principal investigator
Physiotherapy Department, Faculty of Allied Health Sciences, Bayero University, Kano. Nigeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education 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 3 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 15 Nov 2018. 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?
Change in pain Intensity (time frame: Baseline and 6 weeks after beginning treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03398174, which also lists 1 linked publication.
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 15 Nov 2018.