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.: PACTR202201591492888 Date of Approval: 28/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of patient education on pain and quality of life of persons with knee osteoarthritis
Official scientific title The effects of a self-management patient education program on pain and quality of life of people with knee(s) osteoarthritis: a randomized clinical trial
Brief summary describing the background and objectives of the trial Knee osteoarthritis (OA) is the most important chronic rheumatic disease affecting human beings. It is more common among the older population. The objective of OA treatment is to control the symptoms, such as pain, mobility problems and consequently, to improve overall quality of life. Although, self-management patient education programs, such as educational workshops and other learning activities are effective approaches in some chronic diseases, the evidence for arthritis is still inconclusive. The aim of this trial is to compare the effectiveness of an OA of the knee self-management education program with a control group, as determined by improvements in pain scores and quality of life. In this study, we will perform a two-group, randomized (1:1 ratio), controlled study with repeated-measures to examine the differences between the two groups over time. The research sample will be selected from the patients who are referred to a physiotherapy department with a diagnosed mild to moderate knee(s) OA, aging from 45 to 65 years. Positive findings of this trial will pave the road for new methods of cooperation between patients and healthcare providers. Also, patient education ensures that patients are well-informed about their own health and they could avoid any deterioration and disability due to bad practices. Finally, an increased understanding helps patients to make informed decisions about their healthcare avenues.
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 Rehabilitation
Anticipated trial start date 01/03/2022
Actual trial start date 01/03/2022
Anticipated date of last follow up 01/03/2023
Actual Last follow-up date 01/06/2023
Anticipated target sample size (number of participants) 128
Actual target sample size (number of participants) 128
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Self management educational sessions and a conventional physiotherapy program The educational sessions will be provided once a week (2 hours each) for 3 months (i.e., 12 weeks). The physiotherapy sessions will be preformed 3 times per week for 3 months (i.e.,12 weeks). 3 months (i.e., 12 weeks) The intervention consists of 12 weekly educational sessions of 2 hours, with a maximum of 15 participants, this enables participants to incorporate and consolidate information learned from week to week. In each session, 1 hour will be spent on health education in workshop interactive way. The workshops will provide information on knee osteoarthritis; lifestyle and physical activity; weight control and diet; pain management; coping with activity restriction; and medical concerns. The second hour will be spent on questions and discussions. Health professionals will attend the workshops to facilitate the discussions. Facilitators will include nurses, physiotherapists, and occupational therapists that have the knowledge and skills to present information on disease specific topics and accurately respond to complex questions. It is necessary that all health professionals who will participate in discussions meet minimum musculoskeletal knowledge requirements. In addition to the weekly sessions, participants will receive a course book, and educational materials relevant to the topics discussed each week. The health education will be delivered by peer educators. Peer education is believed to have a strong influence. Participants will continue receiving their regular physiotherapy sessions 3 times/week. 64
Control Group conventional physiotherapy 3 times per week for 3 months (i.e., 12 weeks) The participants in the control group will receive regular physiotherapy sessions that include, but not limited to, pain relievers modalities, massage, manual therapy techniques, and exercise.. 64 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Patients who are 45 to 65 years old. 2) Patients who are diagnosed with mild to moderate knee OA (based on X-ray or clinical diagnosis) and referred to a physiotherapy department from a specialist. 3) Patients Who speaks and understands the Arabic language. 4) Patients who are residents of Misrata region and should be able to meet program requirements. 5) Patients are included if they have reported crepitation, swelling and stiffness of one or both knee joints. 1) Patients who have other major health problems (heart disease, renal failure, cancer, mental disorder, or neurologic disease). 2) Patients who have serious comorbidities (rheumatoid arthritis or other inflammatory disease). 3) Patients who are on a waiting list for knee replacement within six months. 4) Patients who cannot meet program time-line and/or have learning disabilities. Middle Aged: 45 Year(s)-64 Year(s) 45 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 31/01/2022 Department of Physiotherapy of the College of Medical Technology
Ethics Committee Address
Street address City Postal code Country
4th round road, Misrata Misrata 218 Libyan Arab Jamahiriya
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 31/01/2022 Research ethics Committee Department of Physiotherapy College of Medical Technology Misrata
Ethics Committee Address
Street address City Postal code Country
4th round street Misrata 218 Libyan Arab Jamahiriya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knee/s pain is the primary outcome which will be measured by self-reported total WOMAC pain score (0–20, with higher scores indicating more pain). Feasibility, validity and reliability of the WOMAC pain score are well established and the questionnaire is sensitive to detect any change in health condition in relation to intervention. 0 - 3 months - 6 months
Secondary Outcome The secondary outcome measure is patients’ quality of life (QoL). Quality of life will be measured by the Arthritis Impact Measurement Scale (AIMS2) and the Short Form (SF-36) questionnaires. There is a strong recommendation in literature to use both AIMS2 and SF36 jointly, as they complement each other. 0 - 3 months - 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Misrata Medical Centre Malta street Misrata 218 Libyan Arab Jamahiriya
FUNDING SOURCES
Name of source Street address City Postal code Country
Alhadi M. Jahan 4th round street Misrata 218 Libyan Arab Jamahiriya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor not applicable not applicable Misrata 218 Libyan Arab Jamahiriya self funded
COLLABORATORS
Name Street address City Postal code Country
Alhadi M. Jahan 10 Hamia street Misrata 218 Libyan Arab Jamahiriya
Ali E. Rwaiha 2nd round road Misrata 218 Libyan Arab Jamahiriya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alhadi Jahan ajaha020@gmail.com +218918994 10 Hamia street
City Postal code Country Position/Affiliation
Misrata 218 Libyan Arab Jamahiriya Principal investigator
Role Name Email Phone Street address
Public Enquiries Ali Rwaiha rwaiha93@yahoo.co.uk +218925103 2nd round road
City Postal code Country Position/Affiliation
Misrata 218 Libyan Arab Jamahiriya Coinvestigator
Role Name Email Phone Street address
Scientific Enquiries Alhadi Jahan ajaha020@gmail.com +218918994 10 Hamia street
City Postal code Country Position/Affiliation
Misrata 218 Libyan Arab Jamahiriya Scientific director and principal investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes, study protocol and individual participant data will be available for responsible requests. We mean by individual data, all data that underlie the results reported in a published article(s), after deidentification (e.g., text, tables, figures, and appendices). Study Protocol Beginning 3 months and ending 36 months following article publication. Data will be shared with researchers who provide a methodologically sound proposal and whose proposed use of the data has been registered by a recognized organization (e.g., Prospero). Data will be shared for any type of analysis and for research purposes only. Proposal should be directed to the principal investigator at ajaha020@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 36 months after the publication. After 36 months, all data will be transferred to the archives department for permanent reservation. Data release from the archives is only accepted under special circumstances.
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