Effectiveness of a group based cognitive behavioural training program in people with knee osteoarthritis pain

ISRCTN	ISRCTN64794760
DOI	https://doi.org/10.1186/ISRCTN64794760
Protocol serial number	N/A
Sponsor	Kuopio University Hospital (Finland)
Funders	Kuopio University Hospital (Finland) EVO grant, Suomen Lääketieteen Säätiö, The Duodecim Foundation (Finland), Finnish Cultural Foundation (Finland)

Submission date: 15/03/2011
Registration date: 04/05/2011
Last edited: 29/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jari Arokoski
Scientific

Department of Physical and Rehabilitation Medicine
Kuopio University Hospital
PO Box 1777
Kuopio
FI-70211
Finland

Email	jari.arokoski@kuh.fi

Study information

Primary study design	Interventional
Study design	Single-blinded randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effectiveness of a group based cognitive behavioural training program in people with knee osteoarthritis pain: a single-blind randomised controlled trial
Study objectives	There is a lack of data on rehabilitation and its cost effectiveness in cognitive behavioral treatment (CBT) modalities of knee osteoarthritis (OA). Therefore, we want to test a CBT model created by Linton in treating patients with knee OA related pain. The proposed research measures the effectiveness and cost effectiveness of a CBT rehabilitation program in patients with knee OA related pain. The proposed study is interdisciplinary clinical research on OA. The research hypothesis is that patients with symptomatic knee OA benefit from a CBT rehabilitation program. The specific aims of the proposed research are: 1. To determine the effect of the intervention in terms of self-reported physical function and pain, pain related work absence, number of pain related health care visits and health related quality of life (HRQoL) 2. To determine the effect of the intervention on psychological variables such as depression, anxiety, sense of coherence, pain catastrophiSing, kinesiophobia, self efficacy and life satisfaction. 3. To run a cost utility analysis of the intervention based on quality adjusted life years (QALY)
Ethics approval(s)	The Ethics Committee of the Kuopio University Hospital, Kuopio, Finland, 02/03/2011, ref: 14/2011
Health condition(s) or problem(s) studied	Knee osteoarthritis
Intervention	A CBT rehabilitation program with 6 weekly meetings will be held by a psychologist. The program takes place in a group of 10 persons according to the model presented by Linton. Each session lasts for 2 hours with a 15─20 minutes break in the middle to enhance peer support and social bonding. The outline of the sessions include introduction (15 min), lecture period (knowledge and insight, max 15 min), problem-solving (in pairs, 15─20 min), skills training (15─20 min), homework assignments (15 min) and a resume (feedback) of the session (15 min). Added as of 21/03/2012. Based on previous study on patients with knee OA the WOMAC pain subscale at baseline was 59.3 mm and a standard deviation of 16.2 mm (Tubach F, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann.Rheum.Dis. 2005;64(1):29-33.). We postulated a mean of at least 48 mm in WOMAC pain subscale at baseline. When comparing mean pain scores between the groups, a two-tailed Student t test with a 5% significance level was used (Campbell MJ, et al. Estimating sample sizes for binary, ordered categorical, and continuous outcomes in two group comparisons. BMJ 1995;311(7013):1145-8). A 20% reduction in primary outcome (WOMAC pain) due to the intervention was considered as being clinically relevant. In order to have 80% test-power and 20% drop-out rate at least 54 patients per group needed to be included in our trial, so we have decided that the target number of participants is 108.
Intervention type	Behavioural
Primary outcome measure(s)	Self-reported pain [WOMAC (VAS) pain subscale]
Key secondary outcome measure(s)	1. Self-reported physical function, pain and stiffness [WOMAC] (VAS) physical function and stiffness subscales, numeric pain rating scale (NPRS), mean and worst pain (past week, 3 months) 2. Depression, anxiety, sense of coherence, pain catastrophising, kinesiophobia, self-efficacy and life satisfaction (BDI-21, BAI, 13-item SOC scale, PCS, TSK, Pain Self-Efficacy Questionnaire, 4-item LS scale) 3. Health-related quality of life and cost effectiveness [RAND-36 (SF-36), 15D, QALY, OA related sick leave, use of pain medication, knee OA related health care visits] 4. GAC (global assessment of change)
Completion date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	108
Key inclusion criteria	1. Age 35-75 years 2. Pain within the last year in or around the knee occurring on most days for at least a month 3. Knee pain greater than or equal to 40 mm on a 100 mm visual analogue scale (VAS) in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale for one week prior to study entry 4. KL 2-4 radiographic knee OA 5. Able to attend six training sessions
Key exclusion criteria	1. Severe psychiatric or psychological disorder 2. Other back or lower limb pain symptoms more aggravating than knee pain 3. Previous lower extremity arthroplasty or planned lower extremity joint surgery 4. Inability to finish the study or unlikely to be compliant
Date of first enrolment	23/08/2011
Date of final enrolment	31/12/2013

Locations

Countries of recruitment

Finland

Study participating centre

Kuopio University Hospital

Kuopio
FI-70211
Finland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2015		Yes	No
Protocol article	protocol	29/01/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

29/06/2016: Publication reference added.

21/03/2012: the following changes were made to the trial record:
1. The target number of participants was changed from 120 to 108.
2. The overall trial start date was changed from 28/03/2011 to 23/08/2011.