Nonspecific Chronic Low Back PainNCT03393104
Patient Education and Motor Control Exercise Among Rural Community-dwelling Adults With Chronic Low Back Pain
A study testing Patient Education in people with Nonspecific Chronic Low Back Pain, run by Bayero University Kano, Nigeria at 1 site in Nigeria.
Trial summary
Low back pain (LBP) is the leading cause of years lived with disability globally with increasing concern about its impact in low- and middle-income countries like those situated in Africa where most people are living in rural areas with limited access to health care. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nonspecific 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
- 120 participants
- Where
- 1 siteNigeria
- Study dates
- 3 Mar 2018to 6 Jan 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female between 16 and 70 years old.
- Primary complaint of LBP with or without leg pain experienced at least over the previous 3 months duration.
- Mean LBP intensity at least ≥ 3 on numerical rating scale during the past week.
- 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: Effects of Patient Education and Motor Control Exercise on Selected Clinical and Psychosocial Variables Among Rural Community-dwelling Adults With Chronic Low Back Pain: a Randomized Clinical Trial
Low back pain (LBP) is the leading cause of years lived with disability globally with increasing concern about its impact in low- and middle-income countries like those situated in Africa where most people are living in rural areas with limited access to health care. Epidemiological studies in Nigeria suggest that the burden of chronic low back pain (CLBP) in rural areas is greater than in urban areas, with both biomechanical and psychological factors being implicated. However, despite the burden of CLBP in rural Nigeria, rehabilitation services are lacking even at the rural primary healthcare centers due to the absence of physiotherapists. Current clinical practice guidelines unanimously recommend education including instruction on self-management options, and exercise as frontline interventions to help individuals with CLBP. However, the specific content of these interventions are rarely described. Patient education (PE) strategies incorporating both biomedical and psychosocial information have been shown to be beneficial for CLBP. Moreover, exercises in the form of motor control exercises (MCEs) have been proven to be effective for CLBP. However, RCTs examining the effects of PE and MCE individually or in combination among rural community-dwelling adults with CLBP are scarce.
The purpose of this study is to determine the effects of PE and MCE program on selected clinical and psychosocial variables among rural community-dwelling adults with nonspecific CLBP.
Read the detailed description
Participants will be recruited and assigned to one of three intervention groups that include PE plus MCE group, MCE group, or PE group using a block random technique based on an electronic randomization table generated by a computer software program. Blinded assessment of all outcomes will be performed at baseline, 8 weeks after randomization and at 3, 6 and 12 months follow-up.
Primary outcomes will be functional disability and pain intensity. Secondary outcomes will be quality of life, global perceived recovery, fear-avoidance beliefs, pain catastrophizing, back pain consequences beliefs, and physical performance (finger-floor test, repeated sit-to-stand test, and the 50-foot walk test) Data will be analyzed using descriptive and inferential (mixed-model ANOVA/linear mixed-effects model) statistics. All statistical analyses will be performed on IBM SPSS Statistics ver. 23.0 (IBM Co., Armonk, NY, USA) at alpha level of 0.05.
- Conditions
- Nonspecific Chronic Low Back Pain
- Being tested
- Motor Control Exercise, Patient Education
- Keywords
- Chronic Low Back Pain, Motor Control Exercise, Patient Education
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
Activation of specific muscles of the lumbopelvic region responsible for providing stability or control of posture and movement.
Patient EducationBehavioural
Also called Cognitive Education
Education aiming to change unhelpful beliefs about LBP, decrease fear avoidance behavior and catastrophic thought, promote positive attitude, self-management, and active coping strategies.
| Study group | Role | What they receive |
|---|---|---|
| Motor Control Exercise and Patient Education | Experimental | Participants will receive a total of 16 sessions (2 sessions per week) of motor control exercise and 4 sessions (1 session per week) of patient education program as described in respective protocol.
In addition, they will also perform segmental stretching exercises and instructed to perform continuous overground walk as indicated in the control group. Receives: Behavioral: Motor Control Exercise; Behavioral: Patient Education |
| Motor Control Exercise | Experimental | Participants will receive a total of 16 sessions (2 sessions per week) of motor control exercise aiming at improving function of specific muscles of the lumbopelvic region and the control of posture and movement.
They will also perform segmental stretching exercises and instructed to perform continuous overground walk as indicated in the control group. Receives: Behavioral: Motor Control Exercise |
| Patient Education | Experimental | Participants will receive patient education session once a week at interval of 1-week over 8-weeks (4 sessions). The program will be aiming to provide non-threatening information to enable patients to better understand their pain, change any unhelpful beliefs about LBP, decrease fear avoidance behavior and catastrophic thought, promote positive attitude, self-management, and active coping strategies.
They will also perform segmental stretching exercises and instructed to perform continuous overground walk as indicated in the control group. Receives: Behavioral: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Change in pain Intensity
Pain Intensity will be measured by an 11-point (0-10) Numerical Pain Rating Scale (NPRS), in which 0 represents "no pain" and 10 represents "worst pain imaginable".
Measured: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Secondary outcomes (8)
Change in quality of life
Quality of life will be measured using the SF-12 health survey. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.
Measured: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Change in global impression of recovery
Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale (GPES). it range from -5 (vastly worse) to 0 (unchanged) to +5 (completely recovered). Higher scores indicate better recovery.
Measured: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Change in fear-avoidance beliefs
Fear avoidance beliefs will be measured by the fear-avoidance beliefs questionnaire (FABQ). The questionnaire consists of 16 self-response items, rated on a seven-point ordinal scale from 0 to 6. It also contains two subscales, a 7-item subscale concerning work, and a 4-item subscale concerning physical activity. Each subscale scores are summed giving possible ranges for the physical activity subscale of 0-24 and for the work subscale between 0-42. Higher score indicate greater fear and avoidance beliefs.
Measured: Baseline, 8 weeks after beginning treatment, and 3-month follow-up
Change in pain catastrophization
Pain catastrophizing will be measured by the pain catastrophizing scale (PCS). The scale consists of 13 items rated on 5-point ordinal scale (0-5).The total score ranges from 0-52 with higher score indicating more catastrophic thoughts.
Measured: Baseline, 8 weeks after beginning treatment, and 3-month follow-up
Change in back pain consequences beliefs
The back pain consequences beliefs will be measured by the Back Beliefs Questionnaire (BBQ). The BBQ is a 14-item scale, with each item rated using a 5-point Likert scale. Nine items (1, 2, 3, 6, 8, 10, 12, 13, and 14) are used for scoring of the questionnaire resulting in a total score ranging from 9-45 with lower scores indicating the more pessimistic beliefs regarding the consequences of back pain.
Measured: Baseline, 8 weeks after beginning treatment, and 3-month follow-up
Change in mobility of the spine and pelvis
The finger-floor distance test (FFD) measures mobility of both the whole spine and the pelvis in the overall motion of bending forward.
Measured: Baseline and 8 weeks after beginning treatment
Change in functional performance of sit-to-stand
The repeated sit-to-stand test measures the time taken to sit-to-stand, five times from a standard chair. The shorter the time taken to complete the test, the better the performance.
Measured: Baseline and 8 weeks after beginning treatment
Change in functional performance of 50-foot walk
The 50-foot walk test measures time taken to walk a distance of 50-foot. The shorter the time taken to complete the test, the better the performance.
Measured: Baseline and 8 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 posted8 Jan 2018
- Study start3 Mar 2018
- Primary completion1 Oct 2019
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nonspecific 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
- 120 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, Principal investigator, Physiotherapy Department, Faculty of Allied Health Sciences, College of Health Sciences, Bayero University, Kano. Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393104
- Sponsor's protocol ID
- SPS/15/PPT/00009
- Status last verified
- Aug 2021
- First submitted
- 6 Dec 2017
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ibrahim AA, Akindele MO, Ganiyu SO. Effectiveness of patient education plus motor control exercise versus patient education alone versus motor control exercise alone for rural community-dwelling adults with chronic low back pain: a randomised clinical trial. BMC Musculoskelet Disord. 2023 Feb 23;24(1):142. doi: 10.1186/s12891-022-06108-9.
PubMed 36823567Ibrahim AA, Akindele MO, Ganiyu SO, Bello B. Effects of motor control exercise and patient education program in the management of chronic low back pain among community-dwelling adults in rural Nigeria: a study protocol for a randomized clinical trial. Integr Med Res. 2019 Jun;8(2):71-81. doi: 10.1016/j.imr.2019.02.001. Epub 2019 Feb 21.
PubMed 31080731
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Patient Education and Motor Control Exercise on Selected Clinical and Psychosocial Variables Among Rural Community-dwelling Adults With Chronic Low Back Pain: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03393104
- Acronym / sponsor ID
- SPS/15/PPT/00009
- Conditions
- Nonspecific Chronic Low Back Pain
- Keywords
- Chronic Low Back Pain, Motor Control Exercise, Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bayero University Kano, NigeriaUniversity, hospital or other
- Study start
- 3 Mar 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 8 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.
Low back pain (LBP) is the leading cause of years lived with disability globally with increasing concern about its impact in low- and middle-income countries like those situated in Africa where most people are living in rural areas with limited access to health care. Epidemiological studies in Nigeria suggest that the burden of chronic low back pain (CLBP) in rural areas is greater than in urban areas, with both biomechanical and psychological factors being implicated. However, despite the burden of CLBP in rural Nigeria, rehabilitation services are lacking even at the rural primary healthcare centers due to the absence of physiotherapists. Current clinical practice guidelines unanimously recommend education including instruction on self-management options, and exercise as frontline interventions to help individuals with CLBP. However, the specific content of these interventions are rarely described. Patient education (PE) strategies incorporating both biomedical and psychosocial information have been shown to be beneficial for CLBP. Moreover, exercises in the form of motor control exercises (MCEs) have been proven to be effective for CLBP. However, RCTs examining the effects of PE and MCE individually or in combination among rural community-dwelling adults with CLBP are scarce.
The purpose of this study is to determine the effects of PE and MCE program on selected clinical and psychosocial variables among rural community-dwelling adults with nonspecific CLBP.
Detailed description
Participants will be recruited and assigned to one of three intervention groups that include PE plus MCE group, MCE group, or PE group using a block random technique based on an electronic randomization table generated by a computer software program. Blinded assessment of all outcomes will be performed at baseline, 8 weeks after randomization and at 3, 6 and 12 months follow-up.
Primary outcomes will be functional disability and pain intensity. Secondary outcomes will be quality of life, global perceived recovery, fear-avoidance beliefs, pain catastrophizing, back pain consequences beliefs, and physical performance (finger-floor test, repeated sit-to-stand test, and the 50-foot walk test) Data will be analyzed using descriptive and inferential (mixed-model ANOVA/linear mixed-effects model) statistics. All statistical analyses will be performed on IBM SPSS Statistics ver. 23.0 (IBM Co., Armonk, NY, USA) at 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 and Patient Education | Experimental | Behavioral: Motor Control Exercise, Behavioral: Patient EducationParticipants will receive a total of 16 sessions (2 sessions per week) of motor control exercise and 4 sessions (1 session per week) of patient education program as described in respective protocol. In addition, they will also perform segmental stretching exercises and instructed to perform continuous overground walk as indicated in the control group. |
| Motor Control Exercise | Experimental | Behavioral: Motor Control ExerciseParticipants will receive a total of 16 sessions (2 sessions per week) of motor control exercise aiming at improving function of specific muscles of the lumbopelvic region and the control of posture and movement. They will also perform segmental stretching exercises and instructed to perform continuous overground walk as indicated in the control group. |
| Patient Education | Experimental | Behavioral: Patient EducationParticipants will receive patient education session once a week at interval of 1-week over 8-weeks (4 sessions). The program will be aiming to provide non-threatening information to enable patients to better understand their pain, change any unhelpful beliefs about LBP, decrease fear avoidance behavior and catastrophic thought, promote positive attitude, self-management, and active coping strategies. They will also perform segmental stretching exercises and instructed to perform continuous overground walk as indicated in the control group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female between 16 and 70 years old.
- Primary complaint of LBP with or without leg pain experienced at least over the previous 3 months duration.
- Mean LBP intensity at least ≥ 3 on numerical rating scale during the past week.
- 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 exerciseActivation of specific muscles of the lumbopelvic region responsible for providing stability or control of posture and movement. | Behavioural | Motor Control Exercise, Motor Control Exercise and Patient Education |
| Patient EducationAlso: Cognitive EducationEducation aiming to change unhelpful beliefs about LBP, decrease fear avoidance behavior and catastrophic thought, promote positive attitude, self-management, and active coping strategies. | Behavioural | Motor Control Exercise and Patient Education, Patient Education |
Primary outcome
Change in functional disability
Time frame: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
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.
Change in pain Intensity
Time frame: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Pain Intensity will be measured by an 11-point (0-10) Numerical Pain Rating Scale (NPRS), in which 0 represents "no pain" and 10 represents "worst pain imaginable".
8 secondary outcomes
Change in quality of life
Time frame: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Change in global impression of recovery
Time frame: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Change in fear-avoidance beliefs
Time frame: Baseline, 8 weeks after beginning treatment, and 3-month follow-up
Change in pain catastrophization
Time frame: Baseline, 8 weeks after beginning treatment, and 3-month follow-up
Change in back pain consequences beliefs
Time frame: Baseline, 8 weeks after beginning treatment, and 3-month follow-up
Change in mobility of the spine and pelvis
Time frame: Baseline and 8 weeks after beginning treatment
Change in functional performance of sit-to-stand
Time frame: Baseline and 8 weeks after beginning treatment
Change in functional performance of 50-foot walk
Time frame: Baseline and 8 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 20 Aug 2021.
- Derived from this study: PubMed 36823567Ibrahim AA, Akindele MO, Ganiyu SO. Effectiveness of patient education plus motor control exercise versus patient education alone versus motor control exercise alone for rural community-dwelling adults with chronic low back pain: a randomised clinical trial. BMC Musculoskelet Disord. 2023 Feb 23;24(1):142. doi: 10.1186/s12891-022-06108-9.
- Derived from this study: PubMed 31080731Ibrahim AA, Akindele MO, Ganiyu SO, Bello B. Effects of motor control exercise and patient education program in the management of chronic low back pain among community-dwelling adults in rural Nigeria: a study protocol for a randomized clinical trial. Integr Med Res. 2019 Jun;8(2):71-81. doi: 10.1016/j.imr.2019.02.001. Epub 2019 Feb 21.
- 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 principal investigator
Physiotherapy Department, Faculty of Allied Health Sciences, College of 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 Nonspecific 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 4 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 Aug 2021. 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 functional disability (time frame: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up). 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 NCT03393104, which also lists 2 linked publications.
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 Aug 2021.