Effectiveness of a group based cognitive behavioural training program in people with knee osteoarthritis pain
| ISRCTN | ISRCTN64794760 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64794760 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Department of Physical and Rehabilitation Medicine
Kuopio University Hospital
PO Box 1777
Kuopio
FI-70211
Finland
| jari.arokoski@kuh.fi |
Study information
| Study design | Single-blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 23/08/2011 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
FI-70211
Finland
Sponsor information
Kuopio University Hospital (Finland)
Hospital/treatment centre
Hospital/treatment centre
FI 70211
Kuopio
1777
Finland
| abc@email.com | |
"ROR" |
https://ror.org/00fqdfs68 |
Funders
Funder type
University/education
Kuopio University Hospital (Finland) EVO grant
No information available
Suomen Lääketieteen Säätiö
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Finnish Medical Foundation
- Location
- Finland
The Duodecim Foundation (Finland)
No information available
Finnish Cultural Foundation (Finland)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Finnish Cultural Foundation, SKR
- Location
- Finland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/01/2013 | Yes | No | |
| Results article | results | 01/09/2015 | Yes | No |
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.
