| - candidate number | 0 |
| - NTR Number | NTR81 |
| - ISRCTN | ISRCTN81350628 |
| - Date ISRCTN created | 20-feb-2007 |
| - date ISRCTN requested | 15-aug-2005 |
| - Date Registered NTR | 29-jun-2005 |
| - Secondary IDs | ZONMW 940-31-060 |
| - Public Title | Comparison of the effectiveness of a behavioural graded activity program and manual therapy in patients with sub-acute neck pain. |
| - Scientific Title | Comparison of the effectiveness of a behavioural graded activity program and manual therapy in patients with sub-acute neck pain. |
| - ACRONYM | N/A |
| - hypothesis | N/A |
| - Healt Condition(s) or Problem(s) studied | Neck complaints |
| - Inclusion criteria | Patients visiting the general practioner with non-specific new complaint or new episode of complaint of the neck (4 to 12 weeks). An episode of complaint is new if patients have not visited their GP for the same complaint the preceding 6 months. Age between 18 and 70 years. |
| - Exclusion criteria | Patients are excluded from the study if a fracture, malignancy, or rheumatoid arthritis casus the presented complaint. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-apr-2002 |
| - planned closingdate | 1-apr-2007 |
| - Target number of participants | 180 |
| - Interventions | Behavioural graded activity program versus manual therapy. |
| - Primary outcome | 1. GPE; 2. global percieved effect; 3. NDI; 4. neck disability index. |
| - Secondary outcome | 1. NRS; 2. Numerical Rating Scale; 3. kinesiofobe (TAMPA); 4. distress; 5. coping; 6. 4 DKL; 7. 4 Dimensional Symptom Questionnaire; 8. PCCL; 9. Pain Coping and Cognition List; 10. costs. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Prof. Dr. Ir. H.C.W. Vet, de |
| - CONTACT for SCIENTIFIC QUERIES | Prof. Dr. Ir. H.C.W. Vet, de |
| - Sponsor/Initiator | VU University Medical Center, EMGO-Institute |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | N/A |
| - Brief summary | N/A |
| - Main changes (audit trail) | |
| - RECORD | 15-aug-2005 - 16-nov-2009 |
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