Effectiveness of group cognitive behavioural therapy on pain, functional disability and psychological outcomes among knee osteoarthritis patients seen at Malaysian government hospital

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001486415
• Date of registration: 25/10/2016
• Prospective Registration: No
• Primary sponsor: Research University Grants (RUGS), University of Putra Malaysia
• Public title: Effectiveness of group cognitive behavioural therapy on pain, functional disability and psychological outcomes among knee osteoarthritis patients seen at Malaysian government hospital
• Scientific title: Effectiveness of group cognitive behavioural therapy on pain, functional disability and psychological outcomes among knee osteoarthritis patients seen at Malaysian government hospital
• Date of first enrolment: 10/08/2015
• Target sample size: 262
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001486415.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Malaysia

Contacts

• Name: Miss Foo Chai Nien

• Name: Miss Foo Chai Nien

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients with OA of the knee who are aged 35 to 75 years;
2. Patients diagnosed with primary knee OA on the basis of medical evaluation (knee pain for most days of previous month and bony enlargement of the knee) and radiographic examination (Kellgren- Lawrence) of grade 2 or more; and
3. Patients with an average pain intensity of 40 or more on a 100mm visual analogue scale in the 7 days before baseline assessment.
4. Written informed consent will be obtained from each patient.

Exclusion criteria: 1. Patients with knee pain caused by conditions other than knee OA;
2. Patients who had knee replacement surgery of the affected knee in the past year;
3. Patients who had undergone psychological treatment or any other clinical study during the past 12 months; and
4. Patients diagnosed with mental disorder, pregnancy or breastfeeding.


Age minimum: 35 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Musculoskeletal - Osteoarthritis

knee osteoarthritis;
knee osteoarthritis

Intervention(s)

The current study will be conducted at Orthopedics Clinic in Malaysian public hospitals, namely Hospital Putrajaya and Hospital Serdang, which are located in the greater Klang Valley area of Selangor, Malaysia. This study consists of a two arm randomised clinical trial involving diagnosed knee OA patients who are eligible to the study. Both the experimental and control group will receive standard routine care throughout the study. Respondents have to attend clinic and physiotherapy session as usual on their fixed appointment date. However, respondents in the control group will be given The Knee Book and not receive further intervention. Respondents in the experimental group will be given The Knee Book and received a three sessions of group CBT (each session will be last for two and a half hours) every two weeks. The sessions will be held in a group of eight to ten respondents under the supervision of an experienced senior clinical psychologist and a physiotherapist. The intervention will be delivered by physiotherapists, nurses and graduate researcher who will undergo at least one day of training, specifically tailored for the trial which will be conducted by an experienced senior clinical psychologist with CBT experience. Each session will be audio- recorded with a written consent from the respondents. Fidelity of the CBT session will be assessed with a random sample of recordings by the experienced psychologist with the Cognitive Therapy Rating Scale (CTS-R).
The Knee Book was adapted with permission from the Ministry of Health, Singapore (Ministry of Health Singapore, 2007). This booklet was based on the Ministry of Health Clinical Practice Guidelines for OA of the Knee and has been written for patients with the aforementioned condition, their family members and c

Primary Outcome(s)

knee pain intensity[mean change in Knee injury and Osteoarthritis Outcome Score (KOOS) knee pain against baseline and six months post treatment completion]

Secondary Outcome(s)

functional disability[mean change in Knee injury and Osteoarthritis Outcome Score (KOOS) functional disability against baseline and six months post treatment completion]

depression[mean change in Depression Anxiety and Stress Scale (DASS) depression score against baseline and six months post treatment completion]

Fear- avoidance beliefs[mean change in fear- avoidance beliefs score against baseline and six months post treatment completion]

Stress[mean change in Depression Anxiety and Stress Scale (DASS) stress score against baseline and six months post treatment completion]

Pain self- efficacy[mean change in pain self- efficacy score against baseline and six months post treatment completion]

Anxiety[mean change in Depression Anxiety and Stress Scale (DASS) anxiety score against baseline and six months post treatment completion]

Pain catastrophising[mean change in pain catastrophising score against baseline and six months post treatment completion]

Secondary ID(s)

NMRR Clinical Trial Registry: NMRR-15-73-24008

Source(s) of Monetary Support

University of Putra Malaysia

Ethics review

Status: Approved
Approval date:
Contact:

National Medical Research Registry (NMRR)