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.: PACTR201804003266300 Date of Approval: 29/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cost-effectiveness of an outpatient self-management program for individuals with knee osteoarthritis; a randomised controlled trial
Official scientific title Clinical effectiveness of an outpatient self-management program for individuals with knee osteoarthritis
Brief summary describing the background and objectives of the trial Osteoarthritis (OA) is the world¿s most common joint disorder causing pain, physical disability and morbidity among older adults (Servick, Miller, Loeser, William, & Messier, 2009). It is also known as a degenerative joint disease that results in changes within the synovial membrane, joint cartilage and bones within the joint, both biochemically and morphologically (Brandt, Dieppe, & Radin, 2008). These changes result in pain, swelling, fatigue, functional limitations, increased healthcare utilization and high economic cost (Servick et al., 2009; Arya & Jain, 2013).There are many different interventions for the management of knee OA.However, the current evidence base, advocates the use of exercise and self-management in the management of knee OA (Zhang et al., 2008; Jordan et al., 2003; Hochberg et al., 2012; Jevsevar et al. 2013). Knee OA is a long term chronic illness, therefore, patients should be made to understand and cope with their problems more effectively, improve adherence to management, advice and reduce healthcare utilization and thought the ways to manage their condition themselves (Lorig, Ritter & Plant, 2005).Studies on self-management in knee OA have been conducted in different settings such as the community dwelling elderly with chronic knee OA (Barlow, Turner & Wright, 2000; Yip et al., 2007; Goeppinger, Armstrong, Schwartz, Ensley & Brady, 2007; Coleman et al., 2008, 2010; Jessep et al., 2009; Kao, Wu, Tsai, Chang & Wu, 2012; Marconcin, Espanha, Yazigi & Campos, 2016), community individuals ages 18years and above (Lorig, Ritter, Laurent & Plant, 2008). This study aims at determining the effectiveness of self-management for patients with knee osteoarthritis using the existing self-management program used in foreign countries to see if it is still applicable to our own setting.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Knee osteoarthritis,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 09/04/2018
Actual trial start date 12/04/2018
Anticipated date of last follow up 29/06/2018
Actual Last follow-up date 06/07/2018
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 68
Recruitment status Not yet recruiting
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation 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 Self-management program And exercise therapy Twice weekly 60mins per session for 6weeks The program will consist of education on self-management principles, managing symptoms, exercise and physical activity, communication skills, healthy eating, and managing medicines. 40 Dose Comparison
Control Group Exercise therapy Individualized twice weekly for 6weeks Repeated sit to stand, balance exercises, exercises that reduces fatigue and increases locomotor function 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Individuals aged 18-65 with grade 1-3 knee OA, Kellgren and Lawrence Individuals with Kellgren and Lawrence grade 4 knee OA History of hip, knee or ankle surgery prior to the study by self report. Intra-articular steroid injection, in the knee, within one month by self-report. Medical or surgical condition severe enough to interfere with quality of life by self report such as type II diabetes, cardiovascular or respiratory disorders, back pain. Knee pain caused by trauma within the past year by self-report. Individuals who had received physiotherapy in the last 30days. 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
No 03/04/2018 Aminu Kano Teaching Hospital ethical committee
Ethics Committee Address
Street address City Postal code Country
Aminu Kano Teaching Hospital area, Gyadi-gyadi Kano 700231 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual analogue scale (VAS) Baseline 3weeks Post-intevention
Secondary Outcome Goniometer Baseline 3weeks Post-intervention
Secondary Outcome EQ-5D Baseline 3weeks Post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Muhammad Specialist Hospital, Kano Mohammed Abdulahi Wase Road Kano Municipal Kano Nigeria Kano Nigeria
Aminu Kano Teaching Hospital AKTH road, Gyadi-gyadi Kano 700231 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Wasila Habibu No 246 Sarki road, Gyadi-gyadi arewa Kano Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor BUK Gwarzo road, Kano Kano Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Wasila Habibu No 246 Sarki road, Gyadi-gyadi arewa Kano Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wasila Habibu hwasila4real@yahoo.com 08037939354 No 246 Sarki road, Gyadi-gyadi Arewa
City Postal code Country Position/Affiliation
Kano Nigeria Postgraduate student
Role Name Email Phone Street address
Public Enquiries Adedapo Awotidebe awotidebe.adedapo@gmail.com 07064665704 Aminu Kano Teaching Hospital, Area: GYADI GYADI / KARKASARA /, Kano, Kano State, Nigeria
City Postal code Country Position/Affiliation
Kano 700233 Nigeria
Role Name Email Phone Street address
Scientific Enquiries Adedapo Awotidebe awotidebe.adedapo@gmail.com 07064665704 Aminu Kano Teaching Hospital, Area: GYADI GYADI / KARKASARA /, Kano, Kano State, Nigeria
City Postal code Country Position/Affiliation
Kano 700233 Nigeria
REPORTING
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