Intensive back training protocol for low back pain
| ISRCTN | ISRCTN45641649 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45641649 |
| Protocol serial number | 945-03-2003 |
| Sponsor | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 945-03-2003). |
- Submission date
- 26/05/2004
- Registration date
- 28/07/2004
- Last edited
- 29/10/2021
- 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
Prof Riekie de Vet
Scientific
Scientific
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 4448176 |
|---|---|
| hcw.devet@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Intensive back training protocol for low back pain |
| Study objectives | Low back pain is defined as pain and discomfort, localised below the costal margin and above the inferior gluteal folds, with or without leg pain. Non-specific low back pain is defined as low back pain not attributed to recognisable, specific pathology (e.g. infection, tumour, osteoporosis, rheumatoid arthritis, fracture, inflammatory process, radicular syndrome or cauda equina syndrome). Hypothesis: This trial will evaluate the cost-effectiveness and cost-utility of the intensive group training protocol compared with physiotherapy guideline care. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Non-specific low back pain. |
| Intervention | Intensive group training protocol (the protocol combines exercise therapy with principles of back school and behavioural therapy) versus physiotherapy guideline care. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Total final enrolment | 114 |
| Key inclusion criteria | Patients will be recruited by participating physiotherapists in Amsterdam and its environment. Inclusion criteria are: 1. Patients with non-specific low back pain 2. Referred to physiotherapy by a general practitioner or medical specialist 3. Current episode of low back pain for more than 6 weeks 4. Age between 18 and 65 years 5. Health insurance with AGIS |
| Key exclusion criteria | 1. Specific low back pain, attributable to e.g. infection, tumour, osteoporosis, rheumatoid arthritis, fracture, inflammatory process, radicular syndrome or cauda equina syndrome 2. Pregnancy 3. Pelvic pain or instability 4. Lawsuit 5. If their general practitioner or medical specialist advised them not to perform physically straining activities |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 29/07/2008 | 29/10/2021 | Yes | No | |
| Protocol article | Protocol | 01/11/2004 | Yes | No |
Editorial Notes
29/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
