Condition category
Musculoskeletal Diseases
Date applied
17/04/2009
Date assigned
11/05/2009
Last edited
19/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Margreth Grotle

ORCID ID

Contact details

FORMI - Communication unit for musculoskeletal disorders
Oslo University Hospital
Oslo
0407
Norway

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The COPE LBP trial: Cognitive Patient Education for Low Back Pain - a cluster randomised controlled trial in primary care

Acronym

COPE

Study hypothesis

Our main hypothesis is that this cognitive intervention will result in higher physical function as compared to usual care. We also hypothesise that the cognitive intervention results in more decreased pain, more satisfied patients, better quality-of life, and is more cost-effective than usual care.

Ethics approval

The Norwegian Regional Committee for Medical Research Ethics, Health Region South-East gave approval in January 2009 (ref: S-08362a, 2008/10435)

Study design

Stratified cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

Non-specific low back pain

Intervention

Stratified cluster randomised controlled trial with family doctors (GP) and physiotherapists (PT) as unit for randomisation. Follow-up after intervention at 4 - 5 weeks, and at 3, 6, and 12 months.

The professionals will be trained in the specific model of LBP treatment based on the biopsychosocial understanding of LBP and the "intensive neurophysiology education". They will thereafter provide their LBP patients in their normal clinical settings with a four-session treatment program consisting of this education program in addition to their normal treatment. The messages provided to the patients by their caregiver will be specifically according to the manual for the trial.

The "intensive neurophysiology education" is developed by a group of British and Australian researchers as an education program for patients with LBP. The cognitive elements of this program is basically an understanding of pain which differs somewhat from the traditional "injury model". The core of this theory is the neurophysiology of pain as sensitisation and neuronal response to inactivity and movement control.

Based on this, the education program has three basic elements:
1. Reduction of what the patient perceive as threatening inputs to the brain
2. Targeting the patients’ own understanding of the pain
3. Exposure to the threatening inputs

Previous studies have documented additional effect of the "intensive neurophysiology education" when combined with physiotherapy treatment. The treatment will be given in four 30-minute sessions once a week for four consecutive weeks. The treatment is specified in a manual for this trial and all intervention doctors and physiotherapists have attended the 18 lessons course. They are also provided with a written summary of the content of each session.

Each of the sessions has a specific content of education and discussion in the one-to-one setting between the provider and the patient. Initially the discussion concerns the thoughts and fears of the patients and their LBP. Eventually, the education program will be more and more dealing with exposure to movements and daily activities the patient more or less deliberately avoid of fear from provoking pain. The patients will be given lessons between the sessions, in addition to registrations on function, pain and work absence.

Control group:
The providers of the two control groups will be asked to in a similar manner register and include all patients meeting the inclusion criteria. These patients will also answer on all questionnaires, and will meet their provider weekly for up to four weeks. These sessions have no defined content, but the providers will spend somewhat more time on these patients than the regular schedule asking more deeply what prevents the patient from resuming normal activity.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Function (disability) assessed by the Roland Morris Disability Questionnaire (RMQ), a self-administered questionnaire with score 0 - 24, with 0 corresponding to no disability.

Secondary outcome measures

1. Pain; measured on a numerical rating scale from 0 to 10
2. Return to work; reported as number of days from first visit to the health care provider until completely or partially return to work - and as a total number of days absent from work the following year
3. Overall satisfaction; measured on a numerical rating scale from 0 to 10
4. Health related quality of life; assessed by the EuroQoL-5D and Patient-Generated Index (PGI)
5. A cost-effectiveness analysis will be carried out by using both the return-to work outcome and the EuroQoL 5D, and by estimating the total cost of all the four groups of doctors and physiotherapists in this trial

Overall trial start date

14/01/2009

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Each practitioner will recruit up to 10 patients, aged 20 to 55 years (either sex), with non-specific subacute/chronic low back pain (LBP) of less than 1 year duration.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Provider's uncertainty of diagnosis
2. Possible nerve root pain or severe pathology
3. Signs of any 'red flags'
4. Particular interest or demand for a specific treatment

Recruitment start date

14/01/2009

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Norway

Trial participating centre

FORMI - Communication unit for musculoskeletal disorders
Oslo
0407
Norway

Sponsor information

Organisation

Oslo University Hospital (Norway)

Sponsor details

FORMI - Communication unit for musculoskeletal disorders
Oslo
0407
Norway

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Oslo University Hospital (Norway) - FORMI (Communication unit for musculoskeletal disorders) will defray costs until a formal funder has been found

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20158897

Publication citations

  1. Protocol

    Werner EL, Storheim K, Løchting I, Grotle M, The COPE LBP trial: cognitive patient education for low back pain--a cluster randomized controlled trial in primary care., BMC Musculoskelet Disord, 2010, 11, 33, doi: 10.1186/1471-2474-11-33.

Additional files

Editorial Notes