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.: PACTR201709002536342 Date of Approval: 21/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of physical agent in the management of osteoarthritis
Official scientific title EFFICACY OF ELECTROTHERAPY ON HEALTH RELATED QUALITY OF LIFE OF NIGERIAN ELDERLY PATIENTS WITH KNEE OSTEOARTHRITIS: RANDOMIZED CONTROLED TRIAL
Brief summary describing the background and objectives of the trial Its estimated 10% of people older than 55 years have symptoms of OA, either radiologic, clinical or both, a quarter of who are severely disabled. As a disease OA is now also identified in younger adults(Sowers et al., 2000), thus if effective intervention is not developed, joint replacement surgery will be needed at earlier age to maintain mobility and quality of life. In the elderly population with knee OA, reduced quadriceps muscles strength and increase postural sway have been reported, both of which may be related to fall. Fall in the elderly population have been a significant health issue in today¿s society (Hausdorff et al., 1997). However, the burden of the disease associates not only with the prevalence, but also on the economy and the health care system of a country. Governments at all levels are currently facing problems regarding the rationale management of health care resources. The economic burden consists of direct and indirect costs, such as cost associated with the drugs, medical services, hospitals, researches, and personnel costs. Indirect cost consists of premature mortality, short and long term morbidity. Osteoarthritis is the most widely form of musculoskeletal diseases, estimated to cost 1-1.5% of the gross domestic production (GDP) of developing countries (Reginster, 2002). AIMS OF THE STUDY This study is aimed at evaluating the efficacy of combination of electrotherapy modalities (US &IFC) versus therapeutic ultrasound and interferential therapy current on musculoskeletal-related variables, pains and Health Related Quality of Life of Nigerian elderly patients with knee osteoarthritis. OBJECTIVES OF THE STUDY The objective of this study is to determine the effects of combination of electrotherapy, US and IFC on the followings musculoskeletal variables on elderly patients with knee osteoarthritis: 1. Pain relief 2. Health-related Quality of life 3. Knee Joint Range of Motion 4. Muscle strength of the arthritic knee.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Osteoarthritis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 04/09/2017
Actual trial start date 02/10/2017
Anticipated date of last follow up 01/08/2018
Actual Last follow-up date 03/09/2018
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 140
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 randomization using a randomisation table from a statistic book numbered comtainer Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Therapeutic Ultrasound Group 3 times a week for 12 weeks 30 minutes Ultrasound treatment 30
Experimental Group Interferential Therapy Current Group 3 times a week for 12 weeks 30 minutes Interferential Therapy 30
Experimental Group Combination Therapy Group 3 times a week for 12 weeks 30 minutes Ultrasound treatment Plus Interferential therapy 30
Control Group Control 3 times a week for 12 weeks 30 minutes Infrared lamp 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients will be included if they meet the following study criteria: ¿Male and female patients aged ¿55 years ¿Diagnosis of knee OA according to the American College of Rheumatology criteria ¿Only patients with symptoms for at least three months ad grade II and III OA confirmed radiographical according to Kellgren-Lawrence grade (Kellgren and Lawrence, 1957). ¿Self-ambulatory ¿Attending Physiotherapy Outpatient Units of RSSH, FMC or Dutse General Hospital ¿Patient with Kellgren-Lawrence grade IV and V radiographic changes. ¿Patients with knee joint diseases other than Osteoarthritis ¿Patient with involvement of the foot joints ¿Patient with serious concomitant systemic diseases ¿ Patient with intra-articular joint fluid effusion ¿ Patient who had corticosteroid or hyaluronic acid injections during last one month, or chondroprotective agent ¿Patient with history of any contraindications to electrotherapy ¿Patient who has undergo knee surgery such as joint replacement or arthroscopy within 6-month prior to study ¿Poor general health status that would interfere with the functional assessments during the study 55 Year(s) 70 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 03/08/2015 University of KwaZulu-Natal, Biomedical research ethics committee
Ethics Committee Address
Street address City Postal code Country
Varsity Drive Durban 4000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain Baseline, 6 weeks and 12 weeks
Primary Outcome Range of motion Baseline, 6 weeks and 12 weeks
Primary Outcome Muscle strength Baseline, 6 weeks and 12 weeks
Secondary Outcome Disability Baseline 6 weeks and 12 weeks
Secondary Outcome Quality of life Baseline, 6 weeks and 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Birnin Kudu Bauchi Road Birnin Kudu 70000 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
College of health sciences Varsity Drive Durban 4000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of KwaZulu-Natal, Biomedical research ethics committee Varsity Drive Durban 4000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Sonill Maharaj S Varsity Drive Durban 4000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zubair Usman zubees2000@yahoo.com 2348028460237 Bauchi road
City Postal code Country Position/Affiliation
Birnin Kudu 7000 Nigeria
Role Name Email Phone Street address
Public Enquiries Bashir Kaka bkaka.pth@buk.edu.ng 2348028460237 Varsity Drive
City Postal code Country Position/Affiliation
Durban 4000
Role Name Email Phone Street address
Scientific Enquiries S Sonill maharajss@ukzn.za.ca 2348028460237 Varsity Drive
City Postal code Country Position/Affiliation
Durban 4000 South Africa
REPORTING
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Result URL Hyperlinks
Changes to trial information