Intensive back training protocol for low back pain

ISRCTN	ISRCTN45641649
DOI	https://doi.org/10.1186/ISRCTN45641649
Secondary identifying numbers	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

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 4448176
Email	hcw.devet@vumc.nl

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
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	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2005
Completion date	01/01/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
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

Sponsor information

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation

Laan van Nieuw Oost Indië 334
P.O. Box 93245
The Hague
2509 AE
Netherlands

Phone	+31 (0)70 349 5111
Email	info@zonmw.nl
"ROR"	https://ror.org/01yaj9a77

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 945-03-2003).

No information available

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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Protocol	01/11/2004		Yes	No
Results article		29/07/2008	29/10/2021	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.