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.: PACTR202007672254335 Date of Approval: 21/07/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of kinesiotaping on disability and pain in patients with rotator cuff tendinopathy
Official scientific title Effects of kinesiotaping on disability and pain in patients with rotator cuff tendinopathy: double blinded randomized clinical trial
Brief summary describing the background and objectives of the trial Kinesiotaping is increasingly used because of its beneficial effects on several muscular and tendino-ligamentary disorders. However, literature shows controversial results regarding the effect of KT on shoulder injuries. The aim of this study was to assess the clinical effects of KT in short and medium term on rotator cuff tendinopathy.
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: Other
Anticipated trial start date 20/05/2019
Actual trial start date 28/05/2019
Anticipated date of last follow up 27/12/2019
Actual Last follow-up date 07/02/2020
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group kinesiotaping 12 days Patients in the KT group benefited from application of 2 strips of KT (pink colour) under 25% tension exerted in the centre of the adhesive tape (the anchoring points were not taut): 1) a Y-shaped strip at deltoid from its insertion to its origin and 2) An I band at supraspinatus muscle applied from its insertion to its origin. 25
Control Group placebo 12 days Patients in the placebo group had 2 tension-free I-strips (of the same colour) : 1) one 12 cm long band at acromioclavicular joint in sagittal plane 2) and one 10 cm long band at the distal insertion of deltoid in horizontal plane. 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age between 20 and 60 years shoulder pain before 150° of active elevation in any plane positive signs of conflict (Neer's or Hawkins sign) on clinical examination. progressive dermatological pathology contraindicating application of an adhesive shoulder bandage history of surgery, fracture or dislocation of shoulder intra-articular corticosteroid infiltration in the previous 6 months cervical or radicular signs hyperpilosis that may impede application of KT Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 24/10/2019 Biomedical Research Ethics Committee University Mohammed V of Rabat
Ethics Committee Address
Street address City Postal code Country
faculty of medicine St Impasse Souissi, Rabat Rabat 10100 Morocco
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 24/10/2019 Biomedical Research Ethics Committee University Mohammed V of Rabat
Ethics Committee Address
Street address City Postal code Country
faculty of medicine St Impasse Souissi, Rabat rabat 10100 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Arabic version of the Disabilitiy of the Arm, Shoulder and Hand (DASH) questionnaire Baseline, at 12th day and at 1 month .
Secondary Outcome Visual Analog Scale for pain at rest Baseline, at 12th day and at 1 month .
Secondary Outcome Visual Analog Scale for pain at active movements Baseline, at 12th day and at 1 month
Secondary Outcome Visual Analog Scale for pain at night Baseline, at 12th day and at 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Ayachi Hospital Sidi Bouhaja Street Sale Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
El Ayachi Hospital Sidi Bouhaja street Sale 11150 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor department of rheumatology B El Ayachi Hospital Sidi Bouhaja Street sale Morocco Hospital
Secondary Sponsor Physical medicine and rehabilitation unit El Ayachi Hospital Sidi Bouhaja Steet Sale Morocco Hospital
COLLABORATORS
Name Street address City Postal code Country
Physical medicine and rehabilitation unit of El Ayachi Hospital Sidi Bouhaja Street Sale 11150 Morocco
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatima Zahrae Taik taikfatimazhrae@gmai.com +212664466928 El Ayachi Hospital
City Postal code Country Position/Affiliation
Sale Morocco Mohammed V University of Rabat
Role Name Email Phone Street address
Public Enquiries Latifa Tahiri latifatahiri@yahoo.fr +212661425506 El Ayachi Hospital
City Postal code Country Position/Affiliation
Sale Morocco Mohammed V university of Rabat
Role Name Email Phone Street address
Scientific Enquiries Fadoua Allali fadouaallali@yahoo.fr +212661181824 El Ayachi Hospital
City Postal code Country Position/Affiliation
Sale Morocco Mohammed V university of Rabat
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the IPD collected during the trail after deidentification Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol immediately after publication. No end data open
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