Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202107663708174 Date of Approval: 06/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Core Stabilization versus Combined versus Core Stabilization-Combined Exercise Regimen in the Management of Chronic Low Back Pain
Official scientific title Comparative Effects of Core Stabilization, Combined and Core Stabilization-Combined Exercise Regiment in the Management of Chronic Low Back Pain
Brief summary describing the background and objectives of the trial Low back pain (LBP) by definition is pain in the region between the lower margin of the 12th rib and the gluteal folds with or without distal radiation to the lower extremity (Hoy et al, 2014). It has been asserted that the prevalence of LBP in adult increased more than 100% in the last decade and it is expected to increase exponentially in the aging population, affecting both men and women in all ethnic groups, with a significant impact on functional capacity and occupational activities (Allegri et al, 2016). It has become a condition of attention amongst researchers in recent times because of its foreseen, unforeseen and present negative impact on the health and wealth of a nation. The international guidelines for management of LBP recommend supervised exercise therapy as a first line treatment. Exercise is a structured physical activity tailored to achieve specific goals. Stretching, strengthening, aerobic, and core stabilization exercises have been applied individually in the management of LBP and each were found to result in varying levels of effectiveness in reducing lower back pain and improving back specific function with core stabilization having a better outcome than other exercise regimen Weng et al (2012). These reliefs of symptom are short-lived thus reflecting the need for a novel therapeutic exercise to treat this condition and its concurrent symptoms with its effect lasting for neither intermediate nor a long time.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 12/05/2021
Actual trial start date 02/06/2021
Anticipated date of last follow up 23/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 76
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Core Stabilization Exercise Group three times per week for five weeks 1)Abdominal bracing: 8 seconds, for 30 repetitions. 2) Bracing with heel slides: 4 seconds, for 20 repetitions. 3) Bracing with leg lift: 4 seconds, for 20 repetitions. 4) Bracing with bridging: 8 seconds, for 30 repetitions. 5) Bracing with bridging and leg lift: 8 seconds, for 30 repetitions. 6) Bracing with standing: 8 seconds, for 30 repetitions. 7) Quadruped arm lift with bracing (one upper limb flexed): 8 seconds, with one upper limb flexed, for 30 repetitions. 8) Quadruped leg lift with bracing (one lower limb is extended and lifted off the supporting surface): 8 seconds, for 30 repetitions 9) Quadruped alternate arm and leg lift with bracing: 8 seconds, for 30 repetitions B) Infra red radiation to the lower back for 15 minutes 19
Experimental Group COMBINED GROUP three times per week for 5 weeks A) Flexibility exercises: 1) Flexion in lying: 5 seconds, for 20 repetitions. 2) Flexion in standing: 5 seconds, for 20 repetitions 3) Extension in lying: for 5 seconds, for 20 repetitions. 4) Extension in standing: 5 seconds, for 20 repetitions. 5) Left trunk rotation: 5 seconds, for 20 repetitions. B) Aerobic exercise: participants will sit on the top of a stationary cycle ergometer (without resistance) and cycle for twenty minutes at 40% -60% heart rate reserve. C) Muscle strength: 1) Traditional curl up: 20 repetition 2) Knee to chest: 20 repetitions 3) Bridging exercises: 20 repetition 4) Prone on hands: 20 repetition 5) Hip extension: 20 repetition 6) Trunk extension: 20 repetition D) Infra red radiation to the lower back for 15 minutes 19
Experimental Group CORE STABILIZATION PLUS COMBINED GROUP Three times per week for five weeks A) CORE STABILITY 1) Abdominal bracing: 8 seconds, for 30 repetitions. 2) Bracing with heel slides: 4 seconds, for 20 repetitions. 3) Bracing with leg lift: 4 seconds, for 20 repetitions. 4) Bracing with bridging: 8 seconds, for 30 repetitions. 5) Bracing with bridging and leg lift: 8 seconds, for 30 repetitions. 7) Quadruped arm lift with bracing (one upper limb flexed): 8 seconds, for 30 repetitions. 8) Quadruped leg lift with bracing (one lower limb is extended and lifted off the supporting surface): 8 seconds, for 30 repetitions. 9) Quadruped alternate arm and leg lift with bracing (contra-lateral upper and lower limbs are extended alternately): 8 seconds, for 30 repetitions. B) FLEXIBILITY 1)Flexion in lying: 5 seconds, for 20 repetitions. 2) Flexion in standing: 5 seconds, for 20 repetitions 3) Extension in lying: 5 seconds, for 20 repetitions. 4) Extension in standing: 5 seconds, for 20 repetitions. 5) Left trunk rotation: 5 seconds each for 20 repetitions. 6) Right trunk rotation: 5 seconds each for 20 repetitions. C) Aerobics exercise: The participants will sit on the top of a stationary cycle ergometer (without resistance) and cycle for twenty minutes at 40% -60% heart rate reserve. C) Muscle strength: 1) Traditional curl up: 20 repetitions. 2) Knee to chest: 20 repetitions. 3) Bridging exercises: 20 repetitions. 4) Prone on hands: 20 repetitions. 5) Hip extension: 20 repetitions. 6) Trunk extension: 20 repetitions. D) Infra red radiation to the lower back for 15 minutes 19
Control Group CONTROL Five weeks INFRA-RED RADIATION (IRR) for 15 minutes only 19 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Individuals who suffer LBP, of not less than three months duration. 2) Individuals who will be aged 35 years and 64 years. 3) Individuals who give informed consent to participate. 1) Individuals that are pregnant will not be recruited. 2) Individuals with recent surgery in the back. 3) Participants with medical or surgical conditions that might hinder exercise performance. 4) Participants with severe psychiatric disorders. Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/04/2021 Research and ethics committee Alex Ekwueme Federal University Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
no 1 Hospital road Abakaliki, Ebonyi State Abakaliki 480213 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The outcome hope to determine the efficacy of core stabilization exercises, combined exercises and core stabilization plus combined exercises regimen in the management of chronic low back pain. the outcome will be measured at the end of 3rd week, 5th week, 3 and 6 months post intervention
Secondary Outcome the outcome hope to compare the efficacy of the different exercise regimen of the study in the management of chronic low back pain patients. the outcome will be measured at the end of 3rd week, 5th week, 3 and 6 months post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State no 1 Hospital road, Abakaliki Abakaliki 480213 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nwodo Obinna Dickson Plot 63 Aguogboriga road, Abakaliki 480213 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nwodo Obinna Dickson no 1 Hospital Abakaliki Abakaliki 480213 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Ibikunle Peter Olarewanju Department of Medical Rehabilitation, Nnamdi Azikiwe University, Awka Nigeria
Dr Okoroafor David Radiology Department, Alex Ekwueme Federal University Teaching Hospital, Abakaliki Ebonyi State Nigeria
Dr Uchendu Emmanuel Radiology Department, Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Obinna Nwodo obinna.dickson10@gmail.com +2347037855171 Plot 63 Aguogboriga street,
City Postal code Country Position/Affiliation
Abakaliki Ebonyi State Nigeria Physiotherapy Department Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State
Role Name Email Phone Street address
Scientific Enquiries Peter Ibikunle po.ibikunle@unzik.edu.ng +2348033362243 Department of Medical Rehabilitation Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka Anambra State 420110 Nigeria Assistant Professor Nnamdi Azikiwe University Awka Anambra State
Role Name Email Phone Street address
Public Enquiries Godwin Ezeja godexy2ke@gmail.com +2348034433816 Physiotherapy Department Alex Ekwueme Federal University Teaching Hospital
City Postal code Country Position/Affiliation
Abakaliki 480213 Nigeria Chief Physiotherapist Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All collected individual participant data, all IPD that underlie results in a publication will be provided or shared Informed Consent Form,Statistical Analysis Plan,Study Protocol This will be done within 12 months of the study completion date All IPD will be accessed via a provided URL or any other means as deemed fit by PACTR
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information