Comparison of the effectiveness of a behavioural graded activity program and manual therapy in patients with sub-acute neck pain

ISRCTN	ISRCTN81350628
DOI	https://doi.org/10.1186/ISRCTN81350628
Protocol serial number	ZonMw: 940-31-060, NTR81
Sponsor	Vrije University Medical Centre (VUMC) (Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof H C W de Vet
Scientific

VU University Medical Centre
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 444 8176
Email	hcw.devet@vumc.nl

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group, double blinded trial.
Secondary study design	Randomised controlled trial
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(s)	1. Global Perceived Effect (GPE) 2. Neck Disability Index (NDI)
Key secondary outcome measure(s)	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
Completion date	01/04/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

VU University Medical Centre

Amsterdam
1081 BT
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/04/2009		Yes	No
Protocol article	Study protocol	01/11/2006		Yes	No