Chronic Low Back PainNCT05102097
Effectiveness of Treadmill Walk on Chronic Low Back Pain
A study testing Warm-up, Main exercise and Cool down in people with Chronic Low Back Pain, run by Bayero University Kano, Nigeria at 1 site in Nigeria.
Trial summary
Chronic low back pain is a common health problem with a multifactorial impact on core muscle function as well as causing pain, functional disability and decrease in quality of life, this occur due to the reduction in the physical activity level of the individual causing atrophy and inhibition of the core muscle… 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?
- Warm-up, Main exercise and Cool down
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNigeria
- Study dates
- 16 Aug 2021to 5 Jan 2023
- 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 females between the age of 18 to 65years
- participants attending Usmanu Danfodiyo University teaching Hospital, Sokoto State Specialist Hospital and Orthopedic Hospital
- participants with chronic non-specific low back pain
Who cannot join
- participants with current low back pain for less than 12 weeks
- participants with cognitive and visual impairment
- participants with other co-morbidities ( systemic disease, carcinomas, organ disease)
- Participants with other neurological findings such as loss of sensation, radiculopathy, parenthesis
- Body mass index of more than 30 Kilogram per meter square
- participants who are pregnant
- participants who had spinal surgery
Trial locations and contacts
1 site in 1 country.
Nigeria1 site, 1 recruiting
- Recruiting
Usmanu Danfodiyo University Teaching Hospital Sokoto
Sokoto, 840102
Bunmi J Nhinlola, Msc, +2348035976946, Bunmifunmi@gmail.com
About this study
Official title: Effectiveness of Treadmill Walk on Clinical and Functional Variables of Chronic Low Back Pain Patients
Chronic low back pain is a common health problem with a multifactorial impact on core muscle function as well as causing pain, functional disability and decrease in quality of life, this occur due to the reduction in the physical activity level of the individual causing atrophy and inhibition of the core muscle affecting the stability of the spine
Read the detailed description
There are several approaches and methods of treating chronic low back pain (CLBP) ranging from education, exercise, electrotherapy and Manual therapy; to alternative treatment such as acupuncture, yoga and Chiropractic. Among the above mention treatment exercise, manual therapy and education are the most frequently utilize for the management of CLBP. The general recommendation for individual with CLBP is to remain active as possible and this can be achieve through exercise.
Evidence shows that active treatment in form of strengthening exercise of the abdominal and back muscles, core stabilization exercise, coordination exercise and aerobic exercise leads to significant reduction in pain and functional disability in patients with CLBP. A number of researches have been focusing on core stability exercise, which is an effective way of recruiting the core muscle (including the abdominal, back, pelvic and hip muscles) that leads to the optimal force production, control of lumbopelvic-hip movement and load transfer from the spine to the pelvis and the lower extremities. The core stabilization exercise has been establish to activate and strength the deep core muscles, but researches are now focusing on the exercise that can be able to activate the core muscles as well as increase the overall health status of the individual
- Conditions
- Chronic Low Back Pain
- Being tested
- Warm-up, Main exercise, Cool down, Standard of care
- Keywords
- Treadmill walk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm-upBehavioural
Participants will walk on treadmill at a speed of 1.7 mile per hour (MPH) and 0 inclination each session for 6weeks 3 times in a week
Main exerciseBehavioural
Participants will walk on a treadmill with a starting speed of 1.7 mile per hour with inclination of 1 to 4% starting with 1% and increased by 1% each week until 4 weeks and at week 5 and 6 speed will be increased to 5mile per hour starting from 1.7mile per hour and increased by 0.5 mile per hour each 1minute while inclination will be increased to 5% in week 5 and 6% in week 6. Main exercise will be perform 3 times in a week for 6 weeks
Cool downBehavioural
Participants will walk on treadmill at the speed of 1.7 mile per hour 0 inclination each session for 6 weeks 3 times in a week
Standard of careBehavioural
Participants will perform Abdominal hollowing, isometric back extension exercise, bridging exercise, graded active flexion, graded active extension by holding for 5seconds and repeated 10times
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Treadmill walk: i- warm up ( 5 minutes ) II- Main exercise (30 minutes) III- cool down (5 minutes) IV- Standard of care (10minutes) Receives: Behavioral: Warm-up; Behavioral: Main exercise; Behavioral: Cool down; Behavioral: Standard of care |
| Control group | Active comparator | Standard of care (10 minutes) Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
A scale of 0 to 10 with 0 indicating no pain and 10 worst pain will be administered to the participants to choose a number indicating their level of pain this will be recorded at base line and 6 weeks after intervention
Measured: 5minutes
Electromyograph
Muscle activity of both lumbar multifidus muscle and rectus abdominous muscle will be assess using neurotrac myoplus pro machine and surface electrode. The assessment will be done both at baseline and at 6weeks after intervention
Measured: 10minutes
Biering-sorensen test
Participant in prone position stabilize at both ankle and hip with the upper trunk out of the plinth will be instructed to extend the trunk and hold position, the more the time the participant is able to hold the position the more the core muscle endurance
Measured: 3 minutes
Abdominal dynamic test
Participants in supine lying position with the knees flexed to 90 degrees and upper limbs across the chest will be instructed to raised the trunk and neck and hold the position this will be timed using stopwatch. The more the time the participant is able to hold the position the more the core muscle endurance
Measured: 3 minutes
Flexion rotation test
Participants in supine position the knees flex the participants will be instructed to touch alternate knees for 90 seconds and number of repetition will be recorded. The higher the number of repetition the more the core muscle endurance
Measured: 3 minutes
Pressure biofeedback stabilizer
Pressure biofeedback stabilizer will be use to assess the strength of rectus abdominous and Lumbar multifidus muscle strength, the pressure biofeedback stabilizer is a simple device that sense changes in pressure with movement, the pressure cell measures from 0-200millimeter of mercury (mmHg), with a precision of 2 millimeter of mercury with 0 being the lowest score and 200 the highest score. To measure any of the core muscle strength the pressure biofeedback stabilizer will be inflated to 70 millimeter of mercury and will be placed underneath the muscle of the participant and instruction will be giving to the participant to contract the muscle by pressing the inflator down, the reading on the sphygmomanometer will then be recorded.
Measured: 4 minutes
Secondary outcomes (2)
Oswestry disability index
This questionnaire will be administered to the participant both English and hausa version will be use pending on the preference of the participant will be ask to fill so as to know their level of functional disability at baseline and 6 weeks after administration. The questionnaire is scored from 0 indicating no disability and 100 maximum disability
Measured: 10 minutes
Short form health survey questionnaire
Short form health survey questionnaire will be administered to the participants the English or Hausa version pending on the participant preference and their quality of life will be assessed both at baseline and 6weeks intervention. The questionnaire will be scored from 0 to 100, with 0 indicating poor quality of life and 100 highest score in terms of quality of life
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start16 Aug 2021
- Primary completion7 Oct 2022 (estimated)
- Study completion5 Jan 2023 (estimated)
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
- Model description
- Group A (experimental group) participants in this group will walk on treadmill and perform standard of care in form of exercises. Group B (Control Group) participants in this group will receive standard of care alone
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayero University Kano, Nigeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahanatu Abubakar Abba, Bayero University Kano, Nigeria
- Investigators
- Rahanatu A Abba, Msc, Principal investigator, Usmanu Danfodiyo University Teaching Hospital Sokoto, Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102097
- Sponsor's protocol ID
- SPS/18/MPT/00018
- Status last verified
- Oct 2021
- First submitted
- 20 Oct 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Treadmill Walk on Clinical and Functional Variables of Chronic Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT05102097
- Acronym / sponsor ID
- SPS/18/MPT/00018
- Conditions
- Chronic Low Back Pain
- Keywords
- Treadmill walk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bayero University Kano, NigeriaUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 7 Oct 2022 (estimated)
- Study completion
- 5 Jan 2023 (estimated)
- First posted
- 1 Nov 2021 (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.
Chronic low back pain is a common health problem with a multifactorial impact on core muscle function as well as causing pain, functional disability and decrease in quality of life, this occur due to the reduction in the physical activity level of the individual causing atrophy and inhibition of the core muscle affecting the stability of the spine
Detailed description
There are several approaches and methods of treating chronic low back pain (CLBP) ranging from education, exercise, electrotherapy and Manual therapy; to alternative treatment such as acupuncture, yoga and Chiropractic. Among the above mention treatment exercise, manual therapy and education are the most frequently utilize for the management of CLBP. The general recommendation for individual with CLBP is to remain active as possible and this can be achieve through exercise.
Evidence shows that active treatment in form of strengthening exercise of the abdominal and back muscles, core stabilization exercise, coordination exercise and aerobic exercise leads to significant reduction in pain and functional disability in patients with CLBP. A number of researches have been focusing on core stability exercise, which is an effective way of recruiting the core muscle (including the abdominal, back, pelvic and hip muscles) that leads to the optimal force production, control of lumbopelvic-hip movement and load transfer from the spine to the pelvis and the lower extremities. The core stabilization exercise has been establish to activate and strength the deep core muscles, but researches are now focusing on the exercise that can be able to activate the core muscles as well as increase the overall health status of the individual
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group A (experimental group) participants in this group will walk on treadmill and perform standard of care in form of exercises. Group B (Control Group) participants in this group will receive standard of care alone
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Warm-up, Behavioral: Main exercise, Behavioral: Cool down, Behavioral: Standard of careTreadmill walk: i- warm up ( 5 minutes ) II- Main exercise (30 minutes) III- cool down (5 minutes) IV- Standard of care (10minutes) |
| Control group | Active comparator | Behavioral: Standard of careStandard of care (10 minutes) |
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 females between the age of 18 to 65years
- participants attending Usmanu Danfodiyo University teaching Hospital, Sokoto State Specialist Hospital and Orthopedic Hospital
- participants with chronic non-specific low back pain
Key exclusion criteria (7 listed)
- participants with current low back pain for less than 12 weeks
- participants with cognitive and visual impairment
- participants with other co-morbidities ( systemic disease, carcinomas, organ disease)
- Participants with other neurological findings such as loss of sensation, radiculopathy, parenthesis
- Body mass index of more than 30 Kilogram per meter square
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 |
|---|---|---|
| Warm-upParticipants will walk on treadmill at a speed of 1.7 mile per hour (MPH) and 0 inclination each session for 6weeks 3 times in a week | Behavioural | Experimental Group |
| Main exerciseParticipants will walk on a treadmill with a starting speed of 1.7 mile per hour with inclination of 1 to 4% starting with 1% and increased by 1% each week until 4 weeks and at week 5 and 6 speed will be increased to 5mile per hour starting from 1.7mile per hour and increased by 0.5 mile per hour each 1minute while inclination will be increased to 5% in week 5 and 6% in week 6. Main exercise will be perform 3 times in a week for 6 weeks | Behavioural | Experimental Group |
| Cool downParticipants will walk on treadmill at the speed of 1.7 mile per hour 0 inclination each session for 6 weeks 3 times in a week | Behavioural | Experimental Group |
| Standard of careParticipants will perform Abdominal hollowing, isometric back extension exercise, bridging exercise, graded active flexion, graded active extension by holding for 5seconds and repeated 10times | Behavioural | Control group, Experimental Group |
Primary outcome
Numeric pain rating scale
Time frame: 5minutes
A scale of 0 to 10 with 0 indicating no pain and 10 worst pain will be administered to the participants to choose a number indicating their level of pain this will be recorded at base line and 6 weeks after intervention
Electromyograph
Time frame: 10minutes
Muscle activity of both lumbar multifidus muscle and rectus abdominous muscle will be assess using neurotrac myoplus pro machine and surface electrode. The assessment will be done both at baseline and at 6weeks after intervention
Biering-sorensen test
Time frame: 3 minutes
Participant in prone position stabilize at both ankle and hip with the upper trunk out of the plinth will be instructed to extend the trunk and hold position, the more the time the participant is able to hold the position the more the core muscle endurance
Abdominal dynamic test
Time frame: 3 minutes
Participants in supine lying position with the knees flexed to 90 degrees and upper limbs across the chest will be instructed to raised the trunk and neck and hold the position this will be timed using stopwatch. The more the time the participant is able to hold the position the more the core muscle endurance
Flexion rotation test
Time frame: 3 minutes
Participants in supine position the knees flex the participants will be instructed to touch alternate knees for 90 seconds and number of repetition will be recorded. The higher the number of repetition the more the core muscle endurance
Pressure biofeedback stabilizer
Time frame: 4 minutes
Pressure biofeedback stabilizer will be use to assess the strength of rectus abdominous and Lumbar multifidus muscle strength, the pressure biofeedback stabilizer is a simple device that sense changes in pressure with movement, the pressure cell measures from 0-200millimeter of mercury (mmHg), with a precision of 2 millimeter of mercury with 0 being the lowest score and 200 the highest score. To measure any of the core muscle strength the pressure biofeedback stabilizer will be inflated to 70 millimeter of mercury and will be placed underneath the muscle of the participant and instruction will be giving to the participant to contract the muscle by pressing the inflator down, the reading on the sphygmomanometer will then be recorded.
2 secondary outcomes
Oswestry disability index
Time frame: 10 minutes
Short form health survey questionnaire
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- 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.
Rahanatu A Abba, Msc principal investigator
Usmanu Danfodiyo University Teaching Hospital Sokoto, 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 Warm-up, Main exercise and Cool down 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 7 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farida G Sumaila, Ph.D (+2348036164228, Fareeda2006@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: 5minutes). The study lists 6 primary outcomes in all. 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 Jul 2022.