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.: PACTR202008710072142 Date of Approval: 26/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of Kinesio-Taping on chronic nonspecific low back pain: A double blinded randomised clinical trial.
Official scientific title The effect of Kinesio-Taping on chronic nonspecific low back pain: A double blinded randomised clinical trial.
Brief summary describing the background and objectives of the trial Low back pain is a chronic, recurrent, sometimes disabling condition; It has risen to number 1 among all disabling chronic conditions in the world. This painful complaint is an extremely frequent reason for consultation. The aim of this study is to assess the effectiveness of Kinesio-Taping in the short and medium-term on pain and function in patients with chronic nonspecific low back pain compared to a placebo.
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 Treatment: Devices
Anticipated trial start date 10/11/2019
Actual trial start date 10/11/2019
Anticipated date of last follow up 10/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Completed
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo 4 days Patients were randomized to the Kinesio-taping group or to the placebo group. In both groups, an adhesive tape was applied to the most painful region of the lower back. Patients sit in a chair without armrests, positioning their trunk in forward flexion as much as possible, arms crossed on the knees. The goal of this position is to achieve maximum stretching of the lumbar spine, surrounding soft tissue and skin. Four I-shaped adhesive strips arranged in a star were used. Once cut, the angles of the strip were rounded in order to limit the points of attachment and thus the early detachment. The first strip was attached horizontally, the second placed vertically and the other two strips placed diagonally to form a star. In the Placebo group: The same adhesive tape with four I-shaped strips was applied in the same region but without tension. 35 Placebo
Experimental Group Kinesio Taping 4 days Patients were randomized to the Kinesio-taping group or to the placebo group. In both groups, an adhesive tape was applied to the most painful region of the lower back. Patients sit in a chair without armrests, positioning their trunk in forward flexion as much as possible, arms crossed on the knees. The goal of this position is to achieve maximum stretching of the lumbar spine, surrounding soft tissue and skin. Four I-shaped adhesive strips arranged in a star were used. Once cut, the angles of the strip were rounded in order to limit the points of attachment and thus the early detachment. In the Kinesio-Taping group: When the lumbar flexion reached its maximum point, the band was stretched to a maximum between 25 and 30% and the middle part of the band was fixed at the site of the pain. The first strip was attached horizontally, the second placed vertically and the other two strips placed diagonally to form a star. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Non-specific chronic low back pain for at least 12 months Age between 18 and 50 years. History intolerance to paracetamol Previous spinal surgery or a progressive tumor Inflammatory spinal pathology, A vertebral fracture, Radiculopathy, a neuropathy or a spinal compression. Patients with excessive hair on the lumbar region or with a progressive dermatological condition The subjects having had a Taping beforehand or rehabilitation in the 6 months preceding the study Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 08/11/2019 Ethics commitee for biomedical research of the University Mohammed V Souissi Rabat
Ethics Committee Address
Street address City Postal code Country
Impasse souissi, rabat Rabat 10100 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome was the Arabic version of the Oswestry Physical and Functional Disability Index (ODI). It is a self-assessment questionnaire used to assess physical and functional disability. It includes 10 sections of six propositions, each evaluated on a scale of 0 to 5. The relative values are reported (total score / total score possible × 100%). Higher scores indicate more severe disability. The Oswestry Disability Index will be calculated at the start, on the 14th day and at four weeks of follow-up.
Secondary Outcome The secondary outcome was the assessment of pain according to the visual analog scale (VAS) evaluated on a scale of 0 to 10. According to a review of the literature, an improvement in pain VAS of 30% is considered to be clinically significant. We also evaluated the function according to the Rolland-Morris score. The assessment was done at the start, on the 14th day and at four weeks.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Ayachi Hospital Impasse souissi, Rabat RABAT 10100 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
El Ayachi Hospital Street Sidi Bouhaja Sale 10100 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor El Ayachi Hospital Street Sidi Bouhaja Sale 10100 Morocco Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ilham Aachari ilhamaachari@gmail.com 212666504852 Street Sidi Bouhaja
City Postal code Country Position/Affiliation
Sale Morocco Rheumatology B departement El Ayachi Hospital
Role Name Email Phone Street address
Scientific Enquiries Fadoua Allali fadouaallali@yahoo.fr 212661181824 Street Sidi Bouhaja
City Postal code Country Position/Affiliation
Sale Morocco Rheumatology B departement El Ayachi Hospital
Role Name Email Phone Street address
Public Enquiries Redouane Abouqal redouane.abouqal@yahoo.fr 212661217813 impasse souissi
City Postal code Country Position/Affiliation
Rabat Morocco Laboratory of Biostatistics clinical research and epideiology Rabat
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes clinical data outcome data Informed Consent Form,Study Protocol 2 months Access controlled data analysis permitted: clinical data and outcome data process for requesting data request by e-mail who will decide: El Ayachi Hospital, Allali Fadoua reviewing requests: academics
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