Condition category
Musculoskeletal Diseases
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
16/12/2015
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 Maaike Leeuw

ORCID ID

Contact details

University Maastricht
Department of Medical Clinical and Experimental Psychology
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3881600
m.leeuw@dmkep.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR417; Project number ZonMw 1436.0002

Study information

Scientific title

BackActive: exposure in vivo in chronic low back pain patients

Acronym

BackActive

Study hypothesis

It is hypothesized that in chronic low back pain patients with fear of movement/(re)injury, exposure in vivo will be more effective in reducing functional disability levels than the usual graded activity treatment.

Ethics approval

Received from local medical ethics committee

Study design

Multicentre randomised single-blind active-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Low back pain

Intervention

Participants are randomly assigned to either exposure in vivo or behavioural graded activity. Through exposure in vivo, participants are motivated to perform activities, through which fear of movement/(re)injury and functional disability are decreased. Graded activity gradually increase physical activity levels by means of positive reinforcement and time contingency principles.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

To evaluate the (cost-)effectiveness of a graded exposure in vivo treatment as compared to behavioural graded activity in patients with chronic low back pain who report substantial pain-related fear.

Primary outcome measures: functional disability, generic functional status

Secondary outcome measures

Physical activity level

Overall trial start date

01/09/2003

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Non-specific low back pain
2. Duration of pain disability 3 months or more
3. Age between 18-65 years
4. Substantial pain-related fear (Tampa Scale for Kinesiophobia >33)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

110

Participant exclusion criteria

1. No consent
2. Illiteracy
3. Pregnancy
4. Substance abuse
5. Involvement in any litigation concerning disability income
6. Specific medical disorders and cardiovascular diseases, preventing participation at physical exercise
7. Low back pain attributable to recognizable pathology (e.g. infection, tumor, osteoporosis, rheumatoid arthritis, fracture, or inflammatory process, prolapsed intervertebral disc)
8. Psychopathology: pretest criteria applied to a standardized test, the SCL-90 and Beck Depression Inventory
9. Patients with restricted disability due to their back pain (Roland Disability Questionnaire score <4)

Recruitment start date

01/09/2003

Recruitment end date

01/09/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Maastricht
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

University Maastricht (UM) (Netherlands)

Sponsor details

Department of Medical Clinical and Experimental Psychology
P.O. Box 616
Maastricht
6200 MD
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

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

2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18242858
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26651828

Publication citations

  1. Results

    Leeuw M, Goossens ME, van Breukelen GJ, de Jong JR, Heuts PH, Smeets RJ, Köke AJ, Vlaeyen JW, Exposure in vivo versus operant graded activity in chronic low back pain patients: results of a randomized controlled trial., Pain, 2008, 138, 1, 192-207, doi: 10.1016/j.pain.2007.12.009.

  2. Results

    Goossens ME, de Kinderen RJ, Leeuw M, de Jong JR, Ruijgrok J, Evers SM, Vlaeyen JW, Is exposure in vivo cost-effective for chronic low back pain? A trial-based economic evaluation, BMC Health Serv Res, 2015, 15, 1, 549.

Additional files

Editorial Notes