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
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

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

Study information

Study designRandomised, active controlled, parallel group, double blinded trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study objectivesA 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) studiedNeck complaints
InterventionBehavioural graded activity program versus manual therapy
Intervention typeOther
Primary outcome measure1. Global Perceived Effect (GPE)
2. Neck Disability Index (NDI)
Secondary outcome measures1. 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 date01/04/2002
Completion date01/04/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants180
Key inclusion criteria1. 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 criteriaPatients are excluded from the study if a fracture, malignancy, or rheumatoid arthritis caused the presented complaint.
Date of first enrolment01/04/2002
Date of final enrolment01/04/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU University Medical Centre
Amsterdam
1081 BT
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre

EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone +31 (0)20 444 8180
Email emgo@vumc.nl
Website http://www.vumc.nl/english/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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