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.: PACTR201810603949411 Date of Approval: 26/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Kinesio Taping Plus Combined Chain Exercises Compared to Combined Chain Exercises Alone on Pain, Functional Limitation, Quality of Life and Range of Motion in Individuals with Knee Osteoarthritis
Official scientific title Effects of Kinesio Taping Plus Combined Chain Exercises Compared to Combined Chain Exercises Alone on Pain, Functional Limitation, Quality of Life and Range of Motion in Individuals with Knee Osteoarthritis
Brief summary describing the background and objectives of the trial Combined chain exercises which is combination of both open kinetic chain and closed kinetic chain exercises have proven to be better than either of the exercises alone in the management of knee OA. On the other hand, kinesiotaping has been shown to reduce knee pain by improving patellofemoral alignment and lowering mechanical stress on soft tissues. While both are effective in management of knee OA, the combined effect of these two modalities is yrt to be examined.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EFFECT OF KT AND CCEs
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 10/12/2018
Actual trial start date
Anticipated date of last follow up 06/01/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Kinesiotaping plus combined chain exercises 12 sessions, 3 sessions per week Two month The therapeutic taping will be done according to the Kenzo Kase’s Kinesio Tape application. And 10 repeatation of straight leg raising, full-arc extension, wall slide and step up and step down exercises. 30
Control Group Combined chain exercises 12 sessions, 3 sessions per week Two month 10 repeatation of straight leg raising, full-arc extension, wall slide and step up and step down exercises. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Individuals aged 18-65 Individual with grade 1-3 knee OA Individuals with allergic reaction to tape or any skin problem Intra-articular steroid injection, in the knee, within 1 month Surgical intervention at the knee and hip Individuals with Kellgren and Lawrence grade 4 knee OA Peripheral vascular disease Local or systemic infection Rheumatic disease other than osteoarthritis. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 06/03/2019 FEDERAL MEDICAL CENTER NGURU YOBE STATE NIGERIA
Ethics Committee Address
Street address City Postal code Country
MACHINA ROAD Nguru 630101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Intensity Before treatment, 4 weeks of treatment and after treatment
Primary Outcome RANGE OF MOTION Before treatment, 4 weeks of treatment and after treatment
Primary Outcome Disability Level Before treatment, 4 weeks of treatment and after treatment
Secondary Outcome Quality of life Before treatment, 4 weeks of treatment and after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL MEDICAL CENTER NGURU MACHINA ROAD NGURU 630101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
shehu usman ibrahim Unguwa Uku Kano 3011 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MUSA SANI DANAZUMI MACHINA ROAD NGURU 630101 Nigeria SELF SPONSORSHIP
COLLABORATORS
Name Street address City Postal code Country
Shehu Usman Ibrahim Unguwa Uku Kano 3011 Nigeria
BASHIR KAKA BUK Road Kano 3011 Nigeria
Basir Bello Court Road Kano 3011 Nigeria
Musa Sani Danazumi Kumbosto Kano 3011 Nigeria
ABDULSALAM MOHAMMED YAKASAI BUK Road Kano 3011 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shehu Usman Ibrahim usmanik28@gmail.com +2347030433882 Unguwa Uku
City Postal code Country Position/Affiliation
Kano 3011 Nigeria Postgraduate Student
Role Name Email Phone Street address
Public Enquiries Musa Danazumi Sani musadanazumiani@gmail.com +2348145123496 Kumbosto
City Postal code Country Position/Affiliation
Kano 3011 Nigeria Postgraduate Student
Role Name Email Phone Street address
Scientific Enquiries BASHIR KAKA bkaka.pth@buk.edu.ng +2348035537101 BUK Road
City Postal code Country Position/Affiliation
Kano 3011 Nigeria Senior Lecturer and Honarary Physiotherapist at Department of Physiotherapy Bayero University Kano
Role Name Email Phone Street address
Scientific Enquiries Bashir Bello nurubash@gmail.com +2348037019137 Court Road
City Postal code Country Position/Affiliation
Kano 3011 Nigeria H.O.D. Department of Physiotherapy Bayero University Kano
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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