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BackActive: Exposure in vivo in chronic low back pain patients.

The cost-effectiveness of a customized cognitive-behavioral exposure in vivo treatment in patients with chronic low back pain reporting fear of movement/(re)injury. A randomized clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24939
Enrollment
110
Registered
2005-09-21
Start date
2003-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic low back pain

Interventions

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/

Sponsors

University of Maastricht, Department of Medical Clinical and Experimental Psychology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Criteria for acceptance in the study are: 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).

Exclusion criteria

Exclusion criteria: Exclusion criteria are: 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).

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Physical activity level.

Contacts

Public ContactMaaike Leeuw

University Maastricht (UM), Department of Medical Clinical and Experimental Psychology, P.O.Box 616

m.leeuw@dmkep.unimaas.nl+31 (0)43 3881600

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)