ClinicalTrials.gg
Status unknownNCT05102097Updated Jul 20, 2022

Effectiveness of Treadmill Walk on Chronic Low Back Pain

An interventional study of Warm-up and Main exercise in Chronic Low Back Pain, sponsored by Bayero University Kano, Nigeria. Status unknown at 1 site in Nigeria. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Bayero University Kano, Nigeria · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

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

02

Conditions studied

  • Chronic Low Back Pain

Browse trials for

Keywords

  • Treadmill walk
03

In context

Low Back Pain

2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Bayero University Kano, Nigeria is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • of more than 30 Kilogram per meter square
  • participants who are pregnant
  • participants who had spinal surgery
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Experimental Group

    Treadmill walk: i- warm up ( 5 minutes ) II- Main exercise (30 minutes) III- cool down (5 minutes) IV- Standard of care (10minutes)

    Behavioral: Warm-up · Behavioral: Main exercise · Behavioral: Cool down · Behavioral: Standard of care

  • Active comparator
    Control group

    Standard of care (10 minutes)

    Behavioral: Standard of care

Interventions

  • BehavioralWarm-up

    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

  • BehavioralMain exercise

    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

  • BehavioralCool down

    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

  • BehavioralStandard of care

    Participants will perform Abdominal hollowing, isometric back extension exercise, bridging exercise, graded active flexion, graded active extension by holding for 5seconds and repeated 10times

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5minutes

  2. 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

    Time frame: 10minutes

  3. 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

    Time frame: 3 minutes

  4. 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

    Time frame: 3 minutes

  5. 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

    Time frame: 3 minutes

  6. 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.

    Time frame: 4 minutes

Secondary outcomes

  1. 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

    Time frame: 10 minutes

  2. 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

    Time frame: 10 minutes

07

Study locations

1 of 1 sites recruiting
  • Usmanu Danfodiyo University Teaching Hospital Sokoto
    Sokoto, 840102, Nigeria
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2021 (actual). Primary completion is estimated for Oct 2022, 13 months after the start.

Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 13 months is above that.

Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2021
First posted
Nov 1, 2021
StartActual
Aug 16, 2021
Primary completionEst.
Oct 7, 2022
CompletionEst.
Jan 5, 2023
Last update
Jul 20, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05102097
Lead sponsor
Bayero University Kano, Nigeria
Responsible party
Rahanatu Abubakar Abba (Principal Investigator, Bayero University Kano, Nigeria) — Principal investigator
First posted
Nov 1, 2021
Start date
Aug 16, 2021
Primary completion
Oct 7, 2022 (estimated)
Completion
Jan 5, 2023 (estimated)
Last update
Jul 20, 2022

Study contacts

Farida G Sumaila, Ph.D
Contact
Fareeda2006@gmail.com
+2348036164228
Rahanatu A Abba, Msc
principal investigator · Usmanu Danfodiyo University Teaching Hospital Sokoto, Nigeria

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion