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.: PACTR201910791448143 Date of Approval: 01/10/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Core Stabilization Exercises and Cognitive Behavioural Therapy on Pain Related Disability And Psychological Status in Patients with Non-specific Chronic Low Back Pain
Official scientific title Efficacy of Core Stabilization Exercises and Cognitive Behavioural Therapy on Pain Related Disability And Psychological Status in Patients with Non-specific Chronic Low Back Pain
Brief summary describing the background and objectives of the trial Non-specific low back pain (NSLBP) can be defined as low back pain (LBP) not attributed to recognisable or known specific pathology (e.g., infection, tumour, osteoporosis, lumbar spine fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome) or a physical disorder resulting in pain and disability (van Tulder et al, 2006; Balagué, et al, 2012). However, neither pain is as a direct physical consequence of dysfunction, nor does the pain automatically result in reduced function or disability (Waddell, 2004). A mantra of the last ten to twenty years in physiotherapy management of patients with low back pain (LBP), has been the biopsychosocial approach reflecting the fact that disability related to LBP must be viewed as a multifactorial problem (Cholewicki et al, 2016). The specific objectives of this study are: 1. To determine the efficacy of core stabilization exercise on pain-related disability, sleep disturbance, self-perceived change and psychological status in patients with NSCLBP. 2. To determine the efficacy of cognitive behavioural therapy on pain-related disability, sleep disturbance, self-perceived change and psychological status in patients with NSCLBP. 3. To compare the efficacy of core stabilization exercises and cognitive behavioural therapy on pain-related disability, sleep disturbance, self-perceived change and psychological status in patients with NSCLBP.
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 01/07/2019
Actual trial start date 01/08/2019
Anticipated date of last follow up 23/08/2019
Actual Last follow-up date 01/10/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 45
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CORE STABILIZATION EXERCISE GROUP CORE STABILIZATION EXERCISE GROUP will be treated with core stabilization exercise for 30 minutes duration with a frequency of two treatment sessions per week. 8 consecutive weeks A. Components of core stability exercise as adopted from protocol of Akodu et al (2015) are listed below: a. Abdominal bracing b. Bracing with heel slides c. Bracing with bridging d. Bracing with leg lift e. Bracing with bridging and leg lift f. Bracing in standing g. Quadruped arms lifts with bracing h. Quadruped leg lifts with bracing i. Quadruped alternate arm and with leg lift with bracing. Abdominal bracing: Participants were instructed in supine position to perform a drawing-in maneuver of the abdomen and hold for 8 seconds, 30 times for 2 minutes. Bracing with heel slides: Participants were instructed in supine lying position to perform drawing-in maneuver of the abdomen and hold with sliding of the heel per leg for 8 seconds, 20 times for 4 minutes. Bracing with leg lift: Participants were instructed in supine lying position to perform drawing-in maneuver of the abdomen and hold it with raising up the leg for 4 seconds, 20 times for 4 minutes. Bracing with bridging: Participants were instructed in supine lying positions to perform draw- in maneuver of the abdomen and Gently lift up the buttocks and hold for 8 seconds, 30 times for 2 minutes. Bracing with bridging and leg lift: Participants were instructed in supine to perform drawing-in maneuver of the abdomen and gently lift up the buttock and with raising up the leg for 8 seconds, 30 times for 4 minutes. Bracing in standing: Participants were instructed to perform drawing-in maneuver of the abdomen in standing for 8 seconds, 30 times for 2 minutes. Quadruped Arm lifts with bracing (flex one upper extremity): Participants were instructed in prone kneeling position to perform drawing in maneuver of the abdomen, flex one upper extremity and hold it for 8 seconds, 30 times on each side for 4 minutes. Quadruped Leg Lifts with bracing (Extending one lower extremity and lifting it off exercise mat) 20
Experimental Group COGNITIVE BEHAVIOURAL THERAPY GROUP Participants will be treated with cognitive behavioural therapy for 1 hour duration with a frequency of one session per week 8 consecutive weeks The CBT protocol is explained in detail as follows (Cherkin et al, 2016): A group CBT format will be used because it has been found effective, more resource efficient than individual therapy and provides patients with the potential benefits deriving from contact with, and support and encouragement from, others with similar experiences and problems (Cherkin et al, 2016). The CBT intervention will consist of eight weekly 1-hour sessions that provide: 1. Education about the role of maladaptive automatic thoughts (e.g., catastrophizing) and beliefs (e.g., one’s ability to control pain, hurt equals harm) in chronic pain, depression, and anxiety. 2. Instruction and practice in identifying and challenging negative thoughts, thought-stopping techniques, use of positive coping self statements, goal-setting, relaxation techniques, and coping with pain flare-ups. 3. Education about activity pacing and scheduling, and about relapse prevention and maintenance of gains. Study participants will be encouraged to regularly practice the CBT techniques on their own. We will recommend participants in CBT to practice techniques daily, and will encourage each person to set their own goals around practice. 20
Control Group BACK CARE EDUCATION GROUP two treatment sessions per week 8 consecutive weeks The back care education outlines were set as follows: 1. Anatomy of the back and biomechanical principle guiding the functions of the human spine. Injurious postures and activities that may hurt the back and how to avoid them. 2. Proper and safe lifting techniques for carrying loads. 3. Good postures that enhance the health of the back in different farming activities and other activities of daily living such as bathing, sitting, getting to and out of bed. 4. The following specific prophylactic instructions will be taught and given to the participants orally and in writing: -Avoid prolonged sitting, bending, stooping and squatting. -Interrupt static posture every thirty minutes before developing any discomfort during work in the farm. -Maintain lumbar lordosis (hollow in the low back) in sitting and other postures. -Use supportive roll/cushion placed in the hollow of the back in sitting position at home. -Avoid sitting on low chairs, stool and soft couch with deep seat. -Use a firm, high chair with a good comfortable back support. -Consciously control and maintain good upright posture when sitting on a seat without back rest or support. -Avoid lifting heavy loads as much as possible: when you have to lift, carry only a moderate load. Before lifting or carry heavy load extend your back five times and after lifting or carrying the load extend your back three times. -Carry out your back exercises daily - bend backward five times with hands placed in the hollow of your back; every hour.(Ayanniyiet al, 2015). 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The following participants will be included in the study: i. Participants with history of NSCLBP of not less than 3 months. ii. Participants with history of non-specific chronic LBP with or without pain radiating to one or both lower limbs. iii. Participants who scored between 24-30 on mini mental scale (Crum et al, 1993). The following participants will be excluded from the study: i. Participants with previous spinal surgeries. ii. Participants with history of trauma to the back. iii. Participants with spinal deformity. iv. Participants with NSCLBP who had cognitive impairment or inability to follow instructions. v. Participants that are not stable because of psychiatric disorder 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 85 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 29/07/2019 College Of Medicine University of Lagos Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
2nd floor, Biomedical Engineering Block, College Of Medicine University of Lagos P.M.B. c, Lagos, Nigeria. Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Pain disability Index (PDI) 2. Hospital Anxiety and Depression Score (HADS) 3. Insomnia severity index first week, end of 4th week and 8th week post treatment.
Secondary Outcome 1. Mini mental scale 2. Global Perceived Effect Scale First week, end of 4th week and end of 8th week post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Ishaga Rd, Idi-Araba, Lagos Lagos 100254 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Thompson Ogunbiyi 38 Somosu street Surulere 10001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Thompson Ogunbiyi 38 somosu street Surulere 101283 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Ashiyat A. Akodu College of medicine, university of Lagos Idi Araba 100001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Thompson Ogunbiyi thompson_ogunbiyi14@yahoo.com +2347069407600 38 somosu street
City Postal code Country Position/Affiliation
Surulere 101283 Nigeria PHYSIOTHERAPIST
Role Name Email Phone Street address
Public Enquiries Sunday Omilabu hrec@cmul.edu.ng +2348028642463 2nd floor, Biomedical Engineering block, College of medicine, University Of Lagos
City Postal code Country Position/Affiliation
Lagos 12003 Nigeria Chairman Health Research Ethics Committee
Role Name Email Phone Street address
Scientific Enquiries Ashiyat Akodu akoduashiyat@gmail.com +2348034269053 College of Medicine University of Lagos, Department of Physiotherapy
City Postal code Country Position/Affiliation
Lagos 101283 Nigeria Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification by anyone who wishes to access the data and for any purpose. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be immediately following publication. no end date. Data will be accessed indefinitely via a link once it's available.
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