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Effectiveness of a group based cognitive behavioural training program in people with knee osteoarthritis pain
ISRCTN ISRCTN64794760
DOI 10.1186/ISRCTN64794760
ClinicalTrials.gov identifier
EudraCT number
Public title Effectiveness of a group based cognitive behavioural training program in people with knee osteoarthritis pain
Scientific title Effectiveness of a group based cognitive behavioural training program in people with knee osteoarthritis pain: a single-blind randomised controlled trial
Acronym N/A
Serial number at source N/A
Study hypothesis 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)

As of 21/03/2012, target number of participants was updated from 120 to 108.
Anticipated start date of trial was amended from 28/03/2011 to 23/08/2011.
Lay summary Not provided at time of registration
Ethics approval The Ethics Committee of the Kuopio University Hospital, Kuopio, Finland approved on 02/03/2011 (reference number 14/2011)
Study design Single-blinded randomised controlled trial
Countries of recruitment Finland
Disease/condition/study domain Knee osteoarthritis
Participants - 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
Participants - 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
Anticipated start date 23/08/2011
Anticipated end date 31/12/2013
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants 108
Interventions 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 minutesí 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.
Primary outcome measure(s) Self reported pain [WOMAC (VAS) pain subscale]
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)
Sources of funding 1. Kuopio University Hospital (Finland) EVO grant
2. Finnish Medical Foundation (Finland)
3. The Duodecim Foundation (Finland)
4. Finnish Cultural Foundation (Finland)
Trial website
Publications 1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23356455
Contact name Dr  Jari  Arokoski
  Address Department of Physical and Rehabilitation Medicine
Kuopio University Hospital
PO Box 1777
  City/town Kuopio
  Zip/Postcode FI-70211
  Country Finland
  Email jari.arokoski@kuh.fi
Sponsor Kuopio University Hospital (Finland)
  Address FI 70211
  City/town Kuopio
  Zip/Postcode 1777
  Country Finland
  Email
Date applied 15/03/2011
Last edited 07/02/2013
Date ISRCTN assigned 04/05/2011
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