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.
ID
Bron
Verkorte titel
Aandoening
Chronic low back pain
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
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Primary outcome measures: functional disability, generic functional status.
Achtergrond van het onderzoek
Fear of movement/(re)injury is an important determinant in the development and maintenance of chronic low back pain (CLBP). CLBP patients with substantial fear of movement/(re)injury might benefit from exposure in vivo treatment that aims to increase physical activity level by means of decreasing fear of movement/(re)injury. During exposure in vivo patients have to perform activities that are considered harmful to the back. Both through the use of exposure in vivo and behavioural experiments fear is reduced, while beliefs about the harmful consequences of activities are disconfirmed.
Patients are randomly assigned to either exposure in vivo or graded activity. Measurements take place twice before treatment, directly after treatment, and 6 and 12 months after treatment. During treatment daily measurements are gathered.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
P.O.Box 616
Maaike Leeuw
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881600
m.leeuw@dmkep.unimaas.nl
Wetenschappelijk
P.O.Box 616
Maaike Leeuw
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881600
m.leeuw@dmkep.unimaas.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL377 |
| NTR-old | NTR417 |
| Ander register | Projectnummer ZonMw : 1436.0002 |
| ISRCTN | ISRCTN88087718 |