Condition category
Musculoskeletal Diseases
Date applied
26/05/2004
Date assigned
28/07/2004
Last edited
09/08/2007
Prospective/Retrospective
Prospectively 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

Prof Riekie de Vet

ORCID ID

Contact details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 4448176
hcw.devet@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

945-03-2003

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2005

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant 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

Recruitment start date

01/01/2005

Recruitment end date

01/01/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

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

Sponsor details

Laan van Nieuw Oost Indië 334
P.O. Box 93245
The Hague
2509 AE
Netherlands
+31 (0)70 349 5111
info@zonmw.nl

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

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

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

Protocol in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15560843

Publication citations

  1. Protocol

    van der Roer N, van Tulder MW, Barendse JM, van Mechelen W, Franken WK, Ooms AC, de Vet HC, Cost-effectiveness of an intensive group training protocol compared to physiotherapy guideline care for sub-acute and chronic low back pain: design of a randomised controlled trial with an economic evaluation. [ISRCTN45641649]., BMC Musculoskelet Disord, 2004, 5, 45, doi: 10.1186/1471-2474-5-45.

Additional files

Editorial Notes