Condition category
Musculoskeletal Diseases
Date applied
20/02/2007
Date assigned
20/02/2007
Last edited
24/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.vumc.nl/english/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes