Contact information
Type
Scientific
Primary contact
Prof H C W de Vet
ORCID ID
Contact details
VU University Medical Centre
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8176
hcw.devet@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ZonMw: 940-31-060, NTR81
Study information
Scientific title
Acronym
Study hypothesis
A behavioural graded activity program will be more effective than manual therapy in patients with sub-acute neck pain.
Ethics approval
Medisch Ethische Toestingscommssie (METC) VUmc on 23/10/2002 (ref: 2002/127).
Study design
Randomised, active controlled, parallel group, double blinded trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Neck complaints
Intervention
Behavioural graded activity program versus manual therapy
Intervention type
Other
Phase
Not Applicable
Drug names
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 trial start date
01/04/2002
Overall trial end date
01/04/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
180
Participant exclusion criteria
Patients are excluded from the study if a fracture, malignancy, or rheumatoid arthritis caused the presented complaint.
Recruitment start date
01/04/2002
Recruitment end date
01/04/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Centre
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (Netherlands)
Sponsor details
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8180
emgo@vumc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
1. Study protocol on http://www.ncbi.nlm.nih.gov/pubmed/16380288
2. Results in http://www.ncbi.nlm.nih.gov/pubmed/18375173
Publication citations
-
Study protocol
Pool JJ, Ostelo RW, Köke AJ, Bouter LM, de Vet HC, Comparison of the effectiveness of a behavioural graded activity program and manual therapy in patients with sub-acute neck pain: design of a randomized clinical trial., Man Ther, 2006, 11, 4, 297-305, doi: 10.1016/j.math.2005.07.006.
-
Results
Vonk F, Pool JJ, Ostelo RW, Verhagen AP, Physiotherapists' treatment approach towards neck pain and the influence of a behavioural graded activity training: an exploratory study., Man Ther, 2009, 14, 2, 131-137, doi: 10.1016/j.math.2007.12.005.