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.: PACTR201807604459572 Date of Approval: 10/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECTIVENESS OF KINESIO TAPING AND CORE-STABILIZATION EXERCISE ON PAIN, DISABILITY, PSYCHOLOGICAL STATUS, SLEEP DISORDER AND KINESIOPHOBIA IN PATIENTS WITH NON-SPECIFIC CHRONIC LOW BACK PAIN
Official scientific title EFFECTIVENESS OF KINESIO TAPING AND CORE-STABILIZATION EXERCISE ON PAIN, DISABILITY, PSYCHOLOGICAL STATUS, SLEEP DISORDER AND KINESIOPHOBIA IN PATIENTS WITH NON-SPECIFIC CHRONIC LOW BACK PAIN
Brief summary describing the background and objectives of the trial Low back pain (LBP) is a serious health condition and it has attracted a significant amount of research (Akinbo et al, 2012). Chronic low back pain is a major muscloskeletal disorder encountered in the clinical setting, with several studies on the effectiveness of various techniques (Smith et al, 2014; Stuber et al, 2014). Different treatment modalities have been used, but there is short-term relief of symptoms and lack of improvement of the atrophy of lumbar multifidus muscles which increases stability of the lumbar spine (Akodu et al, 2014). Given the modest clinical improvement and the lack of a leading therapy, new modalities are being tested within the variety of physiotherapy techniques to enhance the effect size of the treatment being used and therefore increase patient satisfaction. A new treatment option that is very popular in athletes is the Kinesio Taping and it is being widely used in patients with low back pain (Nemitalla-Added et al, 2016). However, most of the clinical trials used Kinesio Taping in isolation, had small samples, and extreme risk of bias. From a logical perspective, Kinesio Taping is not used by physiotherapists as an isolated method of intervention, but as an extra component in the treatment of patients with low back pain in order to increase and lengthen the effect of pain reduction and disability in these patients (Nemitalla-Added et al, 2016). The overall aim of this study is to determine the effects of Kinesio Taping and core stabilization exercises on pain, functional disability, psychological status, sleep disorder and quality of life in non-specific chronic low back pain patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 16/07/2018
Actual trial start date
Anticipated date of last follow up 17/09/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
179098001 College of Medicine, University of Lagos
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Kinesio Taping plus Core Stabilization Group The treatment sessions will be scheduled two times in a week for 8 weeks. The participants will be given core stabilization exercise for 30 minutes of 30 repetitions each with 8 seconds hold and adequate rest combined with kinesio taping application. The participants in the kinesio taping and core stabilization exercise group will receive a kinesio taping treatment protocol adopted from the studies of Parreira et al (2013) and Nemitalla-Added et al (2016). The participants will also receive core stabilization exercises adopted from the study Akodu et al (2015). 15
Experimental Group Core Stabilization Exercise Group The participants will be given core stabilization exercise for 30 minutes of 30 repetitions each with 8 seconds hold The treatment sessions will be scheduled two times in a week for 8 weeks. The participants will also receive core stabilization exercises adopted from the study Akodu et al (2015) 15
Control Group Kinesio Taping Group The treatment sessions will be scheduled two times in a week for 8 weeks. The participants will receive a kinesio taping treatment protocol adopted from the studies of Parreira et al (2013) and Nemitalla-Added et al (2016). 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The following categories of patients will be included in this study: i. Patients with recurrent history of low back pain of not less than three months. ii. Non-pathological low back pain patients. The patients who present with the underlisted will be excluded from the study: i. Previous spinal surgery. ii. Spinal fractures. iii. Diagnosed tumour or infection affecting the spine. iv. Radiological disorders of spondylosis, spondylolisthesis and scoliosis. v. Rheumatic and inflammatory conditions. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 75 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 11/09/2018 College of Medicine University of Lagos Health Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Idi-Araba, Lagos Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Baseline, 4 weeks and 8 weeks
Primary Outcome Functional Disability Baseline, 4 weeks and 8 weeks
Primary Outcome Range of Motion Baseline, 4 weeks and 8 weeks
Secondary Outcome Psychological Status Baseline, 4 weeks and 8 weeks
Secondary Outcome Kinesiophobia Baseline, 4 weeks and 8 weeks
Secondary Outcome Sleep Disorder Baseline, 4 weeks and 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Ishaga Rd, Idi Oro Lagos Nigeria
General Hospital Marina Lagos 1/3 Broad Street, Marina Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ifeoluwa Ogunniran 38 Somosu Street Surulere Lagos Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Odebiyi DO Physiotherapy Department College of Medicine University of Lagos Lagos Nigeria
Dr Akodu AK Physiotherapy Department College of Medicine University of Lagos Lagos Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ifeoluwa Ogunniran ogifesco@hotmail.com +17244671663 426 Borland St
City Postal code Country Position/Affiliation
Pittsburgh 15206 United States of America Postgraduate Student University of Lagos
Role Name Email Phone Street address
Scientific Enquiries Daniel Odebiyi dodebiyi@unilag.edu.ng 2348024717968 Idi-Araba
City Postal code Country Position/Affiliation
Lagos Nigeria Acting Head of Department University of Lagos
Role Name Email Phone Street address
Public Enquiries Ashiyat Akodu aakodu@unilag.edu.ng 2348034269053 Idi-Araba
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Lecturer University of Lagos
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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