Comparison of the effectiveness of a behavioural graded activity program and manual therapy in patients with sub-acute neck pain
ISRCTN | ISRCTN81350628 |
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DOI | https://doi.org/10.1186/ISRCTN81350628 |
Secondary identifying numbers | ZonMw: 940-31-060, NTR81 |
- Submission date
- 20/02/2007
- Registration date
- 20/02/2007
- Last edited
- 24/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof H C W de Vet
Scientific
Scientific
VU University Medical Centre
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Phone | +31 (0)20 444 8176 |
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hcw.devet@vumc.nl |
Study information
Study design | Randomised, active controlled, parallel group, double blinded trial. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Treatment |
Scientific title | |
Study objectives | A behavioural graded activity program will be more effective than manual therapy in patients with sub-acute neck pain. |
Ethics approval(s) | Medisch Ethische Toestingscommssie (METC) VUmc on 23/10/2002 (ref: 2002/127). |
Health condition(s) or problem(s) studied | Neck complaints |
Intervention | Behavioural graded activity program versus manual therapy |
Intervention type | Other |
Primary outcome measure | 1. Global Perceived Effect (GPE) 2. Neck Disability Index (NDI) |
Secondary outcome measures | 1. Numerical Rating Scale (NRS) 2. Tampa Scale for Kinesiophobia (TSK) 3. Distress, coping 4. Four Dimensional Symptom Questionnaire (4 DKL) 5. Pain Coping and Cognition List (PCCL) 6. Costs |
Overall study start date | 01/04/2002 |
Completion date | 01/04/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 180 |
Key inclusion criteria | 1. Patients visiting the general practioner with non-specific new complaint or new episode of complaint of the neck (four to 12 weeks). An episode of complaint is new if patients have not visited their General Practitioner (GP) for the same complaint the preceding six months 2. Aged between 18 and 70 years |
Key exclusion criteria | Patients are excluded from the study if a fracture, malignancy, or rheumatoid arthritis caused the presented complaint. |
Date of first enrolment | 01/04/2002 |
Date of final enrolment | 01/04/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Centre
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Phone | +31 (0)20 444 8180 |
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emgo@vumc.nl | |
Website | http://www.vumc.nl/english/ |
https://ror.org/00q6h8f30 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | Study protocol | 01/11/2006 | Yes | No | |
Results article | Results | 01/04/2009 | Yes | No |