Effectiveness of Treadmill Walk on Chronic Low Back Pain

NCT05102097 | Unknown DMC

• 1 other identifier: SPS/18/MPT/00018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Low Back Pain

Keywords

Treadmill walk

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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

  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.

  4 minutes

Secondary Outcomes (2)

• Oswestry disability index

  10 minutes

• Short form health survey questionnaire

  10 minutes

Study Arms (2)

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)

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

Control group

ACTIVE COMPARATOR

Standard of care (10 minutes)

Behavioral: Standard of care

Interventions

Warm-up 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

Experimental Group

Main exercise 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

Experimental Group

Cool down 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

Experimental Group

Standard of care 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; Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayero University Kano, Nigeria: lead

Study Sites (1)

Usmanu Danfodiyo University Teaching Hospital Sokoto

Sokoto, 840102, Nigeria

RECRUITING

MeSH Terms

Interventions

Warm-Up Exercise; Cool-Down Exercise; Standard of Care

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Post-Exercise Recovery Techniques; Physical Therapy Modalities; Therapeutics; Rehabilitation; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rahanatu A Abba, Msc

  Usmanu Danfodiyo University Teaching Hospital Sokoto, Nigeria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farida G Sumaila, Ph.D

CONTACT

+2348036164228; Fareeda2006@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 1, 2021
• Study Start: August 16, 2021
• Primary Completion: October 7, 2022
• Study Completion: January 5, 2023
• Last Updated: July 20, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)