Effectiveness of Treadmill Walk on Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Warm-up
Main exercise
Cool down
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Treadmill walk
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Usmanu Danfodiyo University Teaching Hospital SokotoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control group
Arm Description
Treadmill walk: i- warm up ( 5 minutes ) II- Main exercise (30 minutes) III- cool down (5 minutes) IV- Standard of care (10minutes)
Standard of care (10 minutes)
Outcomes
Primary Outcome Measures
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
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
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
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
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
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.
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT05102097
First Posted
October 20, 2021
Last Updated
July 19, 2022
Sponsor
Bayero University Kano, Nigeria
1. Study Identification
Unique Protocol Identification Number
NCT05102097
Brief Title
Effectiveness of Treadmill Walk on Chronic Low Back Pain
Official Title
Effectiveness of Treadmill Walk on Clinical and Functional Variables of Chronic Low Back Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
October 7, 2022 (Anticipated)
Study Completion Date
January 5, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bayero University Kano, Nigeria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Treadmill walk
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Upon completion of baseline assessments, participants will be randomly assigned into two groups A and B in 1:1 ( i.e 20 participants per group) ratio using table of random digit generated from excel.
The study will be single-blind whereby only the outcome assessors will be blinded to participant's group allocation but the type of intervention will not be specified. Because of the nature of the intervention it will be difficult to blind the participants.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Treadmill walk: i- warm up ( 5 minutes ) II- Main exercise (30 minutes) III- cool down (5 minutes) IV- Standard of care (10minutes)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Standard of care (10 minutes)
Intervention Type
Behavioral
Intervention Name(s)
Warm-up
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Main exercise
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Cool down
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Intervention Description
Participants will perform Abdominal hollowing, isometric back extension exercise, bridging exercise, graded active flexion, graded active extension by holding for 5seconds and repeated 10times
Primary Outcome Measure Information:
Title
Numeric pain rating scale
Description
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
Time Frame
5minutes
Title
Electromyograph
Description
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
Time Frame
10minutes
Title
Biering-sorensen test
Description
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
Time Frame
3 minutes
Title
Abdominal dynamic test
Description
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
Time Frame
3 minutes
Title
Flexion rotation test
Description
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
Time Frame
3 minutes
Title
Pressure biofeedback stabilizer
Description
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.
Time Frame
4 minutes
Secondary Outcome Measure Information:
Title
Oswestry disability index
Description
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
Time Frame
10 minutes
Title
Short form health survey questionnaire
Description
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
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farida G Sumaila, Ph.D
Phone
+2348036164228
Email
Fareeda2006@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rahanatu A Abba, Msc
Organizational Affiliation
Usmanu Danfodiyo University Teaching Hospital Sokoto, Nigeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Usmanu Danfodiyo University Teaching Hospital Sokoto
City
Sokoto
ZIP/Postal Code
840102
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bunmi J Nhinlola, Msc
Phone
+2348035976946
Email
Bunmifunmi@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Treadmill Walk on Chronic Low Back Pain
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