Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Jari Arokoski


Contact details

Department of Physical and Rehabilitation Medicine
Kuopio University Hospital
PO Box 1777

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Effectiveness of a group based cognitive behavioural training program in people with knee osteoarthritis pain: a single-blind randomised controlled trial


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)

Ethics approval

The Ethics Committee of the Kuopio University Hospital, Kuopio, Finland, 02/03/2011, ref: 14/2011

Study design

Single-blinded randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet


Knee osteoarthritis


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



Drug names

Primary outcome measures

Self-reported pain [WOMAC (VAS) pain subscale]

Secondary outcome measures

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)

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Kuopio University Hospital

Sponsor information


Kuopio University Hospital (Finland)

Sponsor details

FI 70211

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Kuopio University Hospital (Finland) EVO grant

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Suomen Lääketieteen Säätiö

Alternative name(s)

Finnish Medical Foundation

Funding Body Type

private sector organisation

Funding Body Subtype




Funder name

The Duodecim Foundation (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Finnish Cultural Foundation (Finland)

Alternative name(s)

Finnish Cultural Foundation

Funding Body Type

private sector organisation

Funding Body Subtype




Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in:
2015 results in:

Publication citations

  1. Protocol

    Helminen EE, Sinikallio SH, Valjakka AL, Väisänen-Rouvali RH, Arokoski JP, Effectiveness of a cognitive-behavioral group intervention for knee osteoarthritis pain: protocol of a randomized controlled trial., BMC Musculoskelet Disord, 2013, 14, 46, doi: 10.1186/1471-2474-14-46.

  2. Results

    Helminen EE, Sinikallio SH, Valjakka AL, Väisänen-Rouvali RH, Arokoski JP, Effectiveness of a cognitive-behavioural group intervention for knee osteoarthritis pain: a randomized controlled trial, Clin Rehabil, 2015 , 29, 9, 868-881, doi: 10.1177/0269215514558567.

Additional files

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.