Effectiveness of Treadmill Walk on Chronic Low Back Pain

NCT ID: NCT05102097

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-16

Study Completion Date

2023-01-05

Brief Summary

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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

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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

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Experimental Group

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

Group Type EXPERIMENTAL

Warm-up

Intervention Type BEHAVIORAL

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 exercise

Intervention Type BEHAVIORAL

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 down

Intervention Type BEHAVIORAL

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 care

Intervention Type BEHAVIORAL

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

Control group

Standard of care (10 minutes)

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type BEHAVIORAL

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

Interventions

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Warm-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

Intervention Type BEHAVIORAL

Main 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

Intervention Type BEHAVIORAL

Cool 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

Intervention Type BEHAVIORAL

Standard 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayero University Kano, Nigeria

OTHER

Sponsor Role lead

Responsible Party

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Rahanatu Abubakar Abba

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rahanatu A Abba, Msc

Role: PRINCIPAL_INVESTIGATOR

Usmanu Danfodiyo University Teaching Hospital Sokoto, Nigeria

Locations

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Usmanu Danfodiyo University Teaching Hospital Sokoto

Sokoto, , Nigeria

Site Status RECRUITING

Countries

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Nigeria

Central Contacts

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Farida G Sumaila, Ph.D

Role: CONTACT

+2348036164228

Facility Contacts

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Bunmi J Nhinlola, Msc

Role: primary

+2348035976946

Other Identifiers

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SPS/18/MPT/00018

Identifier Type: -

Identifier Source: org_study_id

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