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.: PACTR202108619222230 Date of Approval: 25/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Long-term Effects of Combined Chain Exercises plus Kinesio Taping Compared with Combined Chain Exercises Or Kinesio Taping Alone in Knee Osteoarthritis: A Randomized Clinical Trial
Official scientific title Long-term Effects of Combined Chain Exercises plus Kinesio Taping Compared with Combined Chain Exercises Alone in Knee Osteoarthritis: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Knee osteoarthritis (OA) has been one of the significant courses of lower limb disability and morbidity particularly in overweight or obese individuals. Treatment options for knee OA include surgery and non-surgical care, however, over the past years, the treatment option with which to manage knee OA has shifted to conservative non-pharmacological care. A previous study has indicated that combined chain exercises (CCEs) plus kinesiotaping (KT) are better than combined chain exercises alone in the management of knee OA. However, the previous study reported data for a short-term period and the long-term effect of CCEs and KT is not known. For this reason, this study would like to determine the long term effect of combined CCEs + KT compared with CCEs alone in knee OA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Longterm effect of CCEs plus KT in knee OA
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 06/09/2021
Actual trial start date 06/09/2021
Anticipated date of last follow up 06/09/2022
Actual Last follow-up date 06/09/2022
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
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 Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CCEs plus KT twice a week for 8 weeks Combined Chain Exercises plus Kinesio Taping 30
Control Group CCEs twice a week for 8 weeks Combined Chain Exercises 30 Active-Treatment of Control Group
Control Group KT twice in a week for 8 weeks Kinesio Taping 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
individuals (aged 50 and above) diagnosed as having mild to moderate knee OA (based on the Kellgren and Lawrence grade, I─III classification) will be included in the study. Participants with knee deformity Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 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 26/07/2021 Federal Medical Centre Nguru
Ethics Committee Address
Street address City Postal code Country
02 Machina Road Nguru 630101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain, functional mobility AT BASELINE, 8 weeks OF INTERVENTION, 6 and 12 MONTHS OF FOLLOW-UP
Secondary Outcome Knee range of motion, quality of life AT BASELINE, 8 weeks OF INTERVENTION, 6 and 12 MONTHS OF FOLLOW-UP
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Nguru 02 Machina Road Nguru 630101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Musa Sani Danazumi 02 Machina Road Nguru 630101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Musa Sani Danazumi 02 Machina Road Nguru 630101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Musa Sani Danazumi musadanazumisani@gmail.com +23409028439699 02 machina Road
City Postal code Country Position/Affiliation
Nguru 630101 Nigeria Physiotherapist
Role Name Email Phone Street address
Public Enquiries Shehu Usman Ibrahim usmanik28@gmail.com +23409028439699 02 machina Road
City Postal code Country Position/Affiliation
Nguru 630101 Nigeria Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Abdulsalam Mohammed Yakasai abdulpeace1@gmail.com +23409028439699 02 machina Road
City Postal code Country Position/Affiliation
Nguru 630101 Nigeria Physiotherapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the trial, after deidentification including data that underlie the results (text, tables, figures, and appendices) will be reported in this study. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol September 2023 Through publication web link
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