Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001486415
Ethics application status
Approved
Date submitted
28/09/2016
Date registered
25/10/2016
Date last updated
25/10/2016
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 290233 0
NMRR Clinical Trial Registry: NMRR-15-73-24008
Universal Trial Number (UTN)
U1111-1188-1579
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 300422 0
Condition category
Condition code
Musculoskeletal 300282 300282 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 caregivers.
Intervention code [1] 296011 0
Behaviour
Intervention code [2] 296110 0
Treatment: Other
Comparator / control treatment
There is no active treatment for control arm group. Participants in control group received standard routine care. Participants need to attend their clinic and physiotherapy session as usual based on their fixed appointment date
Control group
Active

Outcomes
Primary outcome [1] 299764 0
knee pain intensity
Timepoint [1] 299764 0
mean change in Knee injury and Osteoarthritis Outcome Score (KOOS) knee pain against baseline and six months post treatment completion
Secondary outcome [1] 328047 0
functional disability
Timepoint [1] 328047 0
mean change in Knee injury and Osteoarthritis Outcome Score (KOOS) functional disability against baseline and six months post treatment completion
Secondary outcome [2] 328048 0
depression
Timepoint [2] 328048 0
mean change in Depression Anxiety and Stress Scale (DASS) depression score against baseline and six months post treatment completion
Secondary outcome [3] 328049 0
Anxiety
Timepoint [3] 328049 0
mean change in Depression Anxiety and Stress Scale (DASS) anxiety score against baseline and six months post treatment completion
Secondary outcome [4] 328050 0
Stress
Timepoint [4] 328050 0
mean change in Depression Anxiety and Stress Scale (DASS) stress score against baseline and six months post treatment completion
Secondary outcome [5] 328051 0
Fear- avoidance beliefs
Timepoint [5] 328051 0
mean change in fear- avoidance beliefs score against baseline and six months post treatment completion
Secondary outcome [6] 328052 0
Pain self- efficacy
Timepoint [6] 328052 0
mean change in pain self- efficacy score against baseline and six months post treatment completion
Secondary outcome [7] 328055 0
Pain catastrophising
Timepoint [7] 328055 0
mean change in pain catastrophising score against baseline and six months post treatment completion

Eligibility
Key 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.
Minimum age
35 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation using the block randomisation method will be implemented by an individual who is not involved in the recruitment process. The randomised names will be divided into 15 smaller subgroups in each experimental and control group. The subgroup lists will be given to the hospital staffs. All the names in the subgroups will be contacted personally before every assignment by different hospital staffs, who will not have visibility on the group allocation. Therefore, the allocation will be concealed in advance from the patients, researchers involved in recruitment, hospital staffs and therapists.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Those patients who are eligible and willing to participate in this study will be randomly assigned to either of the experimental or control group based on block randomisation method by using random allocation software (http://random-allocation-software.software.informer.com/2.0/) after the written consent is obtained.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed design repeated measure ANOVA

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/08/2015
Date of last participant enrolment
Anticipated
Actual
9/10/2015
Date of last data collection
Anticipated
Actual
5/08/2016
Sample size
Target
262
Accrual to date
Final
300
Recruitment outside Australia
Country [1] 8270 0
Malaysia
State/province [1] 8270 0
Selangor Darul Ehsan

Funding & Sponsors
Funding source category [1] 294596 0
University
Name [1] 294596 0
University of Putra Malaysia
Country [1] 294596 0
Malaysia
Primary sponsor type
University
Name
Research University Grants (RUGS), University of Putra Malaysia
Address
University of Putra Malaysia, Jalan UPM, 43400 Serdang, Selangor Darul Ehsan
Country
Malaysia
Secondary sponsor category [1] 293464 0
None
Name [1] 293464 0
None
Address [1] 293464 0
None
Country [1] 293464 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296043 0
National Medical Research Registry (NMRR)
Ethics committee address [1] 296043 0
Medical Research & Ethics Committee
Ministry of Health Malaysia
Jalan Rumah Sakit, Bangsar
59000 Kuala Lumpur
Ethics committee country [1] 296043 0
Malaysia
Date submitted for ethics approval [1] 296043 0
20/01/2015
Approval date [1] 296043 0
27/07/2015
Ethics approval number [1] 296043 0
NMRR-15-73-24008

Summary
Brief summary
This study aimed to develop, implement and perform an evaluation on the efficacy of a cognitive behavioural therapy module among knee OA patients that would reduce knee pain intensity, functional disability, psychological distress (depression, anxiety and stress), pain catastrophising, fear- avoidance beliefs, and improve pain self- efficacy level.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1131 1131 0 0
/AnzctrAttachments/371567-RESEARCH PROPOSAL_141215.pdf (Protocol)
Attachments [2] 1133 1133 0 0
/AnzctrAttachments/371567-Foo Chai Nien - ApprovalLetter_MREC_1_260715.pdf (Ethics approval)
Attachments [3] 1135 1135 0 0
/AnzctrAttachments/371567(v28-09-2016-15-13-28)-Foo Chai Nien - PIS-Eng.pdf (Participant information/consent)

Contacts
Principal investigator
Name 69326 0
Miss Foo Chai Nien
Address 69326 0
No. 33, Jalan Indah 1/11 B Taman University Indah 43300 Seri Kembangan Selangor Darul Ehsan
Country 69326 0
Malaysia
Phone 69326 0
+60123167252
Fax 69326 0
Email 69326 0
foo_chainien@yahoo.com
Contact person for public queries
Name 69327 0
Miss Foo Chai Nien
Address 69327 0
No. 33, Jalan Indah 1/11 B Taman University Indah 43300 Seri Kembangan Selangor Darul Ehsan
Country 69327 0
Malaysia
Phone 69327 0
+60123167252
Fax 69327 0
Email 69327 0
foo_chainien@yahoo.com
Contact person for scientific queries
Name 69328 0
Miss Foo Chai Nien
Address 69328 0
No. 33, Jalan Indah 1/11 B Taman University Indah 43300 Seri Kembangan Selangor Darul Ehsan
Country 69328 0
Malaysia
Phone 69328 0
+60123167252
Fax 69328 0
Email 69328 0
foo_chainien@yahoo.com

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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