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.: PACTR201705002241375 Date of Approval: 28/04/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Combined lumbar stabilization exercise and cognitive behavioral therapy on selected variables of individuals with non-specific low back p
Official scientific title Effects of a combined lumbar stabilization exercise and cognitive behavioral therapy on selected variables of individuals with non-specific low back pain
Brief summary describing the background and objectives of the trial Cognitive Behavioural Therapy (CBT) is generally accepted as an effective treatment for the biopsychosocial aspect of chronic pain. However, previous researches on CBT in Non-specific Chronic low back pain (NSCLBP) are inconclusive. Lumbar stabilization Exercise (LSE) on the other hand has been found to be effective in managing the clinical components of NSCLBP but has no effect on the biopsychosocial component. This study was carried out to determine whether CBT along with lumbar stabilization exercises has more therapeutic benefit in terms of reduction in pain, disability and fear avoidance beliefs of patients with NSCLBP as compared with lumbar stabilization Exercises alone.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied chronic low back pain,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 28/03/2016
Actual trial start date 28/03/2016
Anticipated date of last follow up 05/12/2016
Actual Last follow-up date 08/12/2016
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 37
Recruitment status Closed to recruitment,follow-up continuing
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 Participants were consecutively assigned into either the CBTL or LSG by the researcher. The first available pair of participants were assigned into either of the 2 groups using the toss of the coin where the person who tossed tail was assigned to the CBTL and the head to the LSG. Consecutive participants were then assigned to the alternate group. Toss of a coin Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CBT PLUS LSE Twice weekly 45 minutes Combined cognitive behavioural therapy plus Lumbar stabilization exercise 19
Experimental Group CBT PLUS LSE Twice weekly 45 minutes Combined cognitive behavioural therapy plus Lumbar stabilization exercise 19 Active-Treatment of Control Group
Control Group Lumbar stabilization exercise Twice weekly 30 minutes lumbar stabilization exercise only 18 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Participants diagnosed with LBP of mechanical origin and have been present for 3 months or more. 2. Participants who gave consent to participate in the study. 3. Participants who can comprehend instructions in English or Hausa. 4. Participants who are not involved in any other form of exercise training during the course of the study. 1. Participants with a history of a prior surgery to the lumbosacral spine. 2. Participants with any neurological findings indicating radiculopathy. 3. Participants with any evidence of systemic disease, carcinoma or organ diseases. 38 Year(s) 50 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 18/02/2016 Research ethics committee of Aminu Kano Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
No. 23 Zaria Road, P.M.B 3452 Kano. P.M.B 3452 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain intensity At baseline After 8 weeks
Primary Outcome Functional disability At baseline After 8 weeks
Secondary Outcome Fear Avoidance Beliefs At baseline After 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aminu kano Teaching Hospital Zaria Road, P.M.B. 3452 KANO 234777 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
NIL NIL
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FATIMA YAHAYA ALIYU No. 25 Gwarzo Road, BUK newsite Kano. 234777 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Bashir Bello Physiotherapy Department, Faculty of Allied Health Sciences, Kano. 234777 Nigeria
Awotidebe Adedapo Wasiu Physiotherapy Department, Faculty of Allied Health Sciences, Kano. 234777 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatima Yahaya Aliyu aliyufatima12@yahoo.com +2348034851104 Karkasara, Tarauni
City Postal code Country Position/Affiliation
Kano. 234777 Nigeria Clinician
Role Name Email Phone Street address
Public Enquiries ABUBAKAR MAHMUD enquiries@akth.org.ng +2347068297399 zaria road, Kano
City Postal code Country Position/Affiliation
Kano. 234777 Nigeria Secretary Ethics Committee
Role Name Email Phone Street address
Scientific Enquiries Bashir Bello nurubash@gmail.com +2348037019137 Physiotherapy Department, Faculty of Allied Health Sciences,
City Postal code Country Position/Affiliation
Kano. 234777 Nigeria SENIOR LECTURER
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information