Low back pain in German primary care - qualitative process evaluation of a feasibility study evaluating a practice nurse-led behavioural intervention
| ISRCTN | ISRCTN33541376 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33541376 |
- Submission date
- 14/01/2024
- Registration date
- 19/02/2024
- Last edited
- 27/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Chronic low back pain is a common condition. Cognitive behavioural therapy (CBT) can be helpful, but there are not enough CBT therapists. In order to meet the demand, specially trained practice nurses in primary care could be helpful. The aim of this pilot study is to evaluate the acceptability of this approach in a pragmatic group programme for patients with chronic back pain.
Who can participate?
Patients between 18 and 65 years old with chronic low back pain
What does the study involve?
Practice nurses from one general practice were instructed in performing the training of five sessions with a group of up to six patients. After completion of the training cycle, acceptability and satisfaction were evaluated through semi-structured interviews with practice nurses and patients.
What are the possible benefits and risks of participating?
Patients in rural areas could benefit from this otherwise difficult-to-access but effective method in their local GP practice. There are no foreseeable risks for patients.
Where is the study run from?
Universitätsmedizin Rostock (Germany)
When is the study starting and how long is it expected to run for?
February 2012 to November 2014
Who is funding the study?
Institut für Allgemeinmedizin Universitätsmedizin Rostock (Germany)
Who is the main contact?
Dr Gregor Feldmeier, gregor.feldmeier@med.uni-rostock.de
Contact information
Public, Scientific, Principal Investigator
Institut für Allgemeinmedizin
Universitätsmedizin Rostock
Doberaner Straße 142
18057 Rostock
Rostock
18057
Germany
 ORCID ID |
0000-0001-7420-5752 |
|---|---|
| Phone | +49 (0)381 494 2481 |
| gregor.feldmeier@med.uni-rostock.de |
Study information
| Study design | Feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Practice-nurse-led behaviour-intervention for low back pain in German primary care – qualitative process evaluation of a feasibility study |
| Study acronym | COPAIN |
| Study objectives | Behavioural therapy-oriented group training with psychoeducational elements for patients with chronic back pain can be carried out by practice nurses in German primary care. |
| Ethics approval(s) |
Submitted 16/07/2012, Ethics Committee of the Rostock University Medical Centre (St.-Georg-Str. 108, Rostock, 18055, Germany; +49 (0)381 494 9900; ethik@med.uni-rostock.de), ref: A 2012-0087 |
| Health condition(s) or problem(s) studied | Chronic back pain |
| Intervention | In collaboration with a psychologist, psychotherapist and general practitioner, a training concept for chronic pain management based on behavioural principles was developed. Practice nurses from one general practice were instructed to perform the training of five sessions with a group of up to six patients. |
| Intervention type | Behavioural |
| Primary outcome measure | Implementability of a training program for patients, which included five sessions of 90 minutes each and focused in particular on the practice of progressive muscle relaxation according to Jacobson, assessed using a qualitative research method (a semi-structured interview with the practice nurses and patients) after completion of the training cycle |
| Secondary outcome measures | 1. Pain intensity is measured with the Brief Pain Inventory (BPI) at Pre-intervention, before the 1st training session (T0), Post-intervention, after the last training session (T2) and as a follow-up, 3-6 months after the end of the training (T3) 2. Mental and physical state of health is measured using the Short Form Health Survey (SF-12) at Pre-intervention, before the 1st training session (T0), Post-intervention, after the last training session (T2) and as a follow-up, 3-6 months after the end of the training (T3) 3. Symptoms of depression and anxiety are measured using the Hospital Anxiety and Depression Scale (HADS) at Pre-intervention, before the 1st training session (T0), Post-intervention, after the last training session (T2) and as a follow-up, 3-6 months after the end of the training (T3) 4. Coping strategies and pain acceptance are measured by the Chronic Pain Acceptance Questionnaire (CPAQ) at Pre-intervention, before the 1st training session (T0) and Post-intervention, after the last training session (T2) 5. Pain-related disability in daily life is measured using the Roland and Morris Disability Questionnaire (RMDQ) at Pre-intervention, before the 1st training session (T0), Post-intervention, after the last training session (T2) and as a follow-up, 3-6 months after the end of the training (T3) |
| Overall study start date | 08/02/2012 |
| Completion date | 20/11/2014 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 15 |
| Total final enrolment | 15 |
| Key inclusion criteria | 1. Between 18 and 65 years old 2. Suffered from back pain for at least 6 months 3. Able to perform the training cognitively and physically |
| Key exclusion criteria | 1. Migraine headaches 2. Severe concomitant illnesses 3. Severe underlying mental illnesses 4. Patients taking opiates were only included after direct consultation and consideration with the study team |
| Date of first enrolment | 27/07/2012 |
| Date of final enrolment | 21/11/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
Rostock
18055
Germany
Sponsor information
University/education
Institute of General Practice
Postbox 100888
Rostock
18055
Germany
| Phone | +49 (0)381 494 2481 |
|---|---|
| ifa.sekretariat@med.uni-rostock.de | |
| Website | http://www.med.uni-rostock.de/ |
"ROR" |
https://ror.org/04dm1cm79 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets created as part of the current study are stored in a repository that is not publicly accessible (managed by Dr Gregor Feldmeier). The study data are not freely accessible but can be viewed if necessary after consultation with the person responsible for the study (Dr Gregor Feldmeier, gregor.feldmeier@med.uni-rostock.de). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/05/2025 | 27/05/2025 | Yes | No |
Editorial Notes
27/05/2025: Publication reference added.
26/01/2024: Study's existence confirmed by the Ethics Committee of the Rostock University Medical Centre.
