Contact information
Type
Scientific
Primary contact
Prof Bart Koes
ORCID ID
Contact details
PO Box 1738
Rotterdam
3000 DR
Netherlands
+31 (0)10 4087620
b.koes@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Ephysion (Effectiveness Physiotherapy in Neck pain)
Study hypothesis
A randomised clinical trial (RCT) has been designed to assess the effectiveness of behavioural graded activity compared with physiotherapy treatment in patients with chronic non-specific neck pain.
Ethics approval
The study design has been approved by the Medical Ethics Technical Commission of the Erasmus MC, University Medical Centre in Rotterdam and is in compliance with the Helsinki Declaration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic non-specific neck pain
Intervention
The behavioural graded activity program is based on an operant approach, which uses a time-contingent method to increase the patient's activity level. This program is compared with a physiotherapy treatment using a pain-contingent method.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
'Global perceived effect' (neck complaint and functioning in daily activities) (1 - 7 on the Likert scale), measured at 4, 9, 26 and 52 weeks.
Secondary outcome measures
1. Main complaint (0 10 on the Likert scale), measured at baseline, 4, 9, 26 and 52 weeks
2. Pain (Visual Analogue Scale [VAS]), measured at baseline, 4, 9, 26 and 52 weeks
3. Medical consumption (dose per day), measured at baseline, 4, 9, 26 and 52 weeks
4. Coping with Multi-dimensional pain (Multidimensional Pain inventory [MPI] Part I-II and 0 6 on the Likert scale), measured at baseline, 9, 26 and 52 weeks
5. Activity (MPI, part III) (0 6 on the Likert scale), measured at baseline, 4, 9, 26 and 52 weeks
6. Specific functional status (Neck Disability Index [NDI]), measured at baseline, 4, 9, 26 and 52 weeks
7. Quality of life, measured using the 36-item Short Form (SF-36) at baseline, 9, 26 and 52 weeks, and the Euroquol 5-Dutch language version (EQ-5d) at baseline, 4, 9, 26 and 52 weeks
8. Work activities Hours/week, measured at baseline, 9, 26 and 52 weeks
9. Satisfaction about treatment (1 5 on the Likert scale), measured at 4, 9 and 26 weeks
10. Compliance with treatment exercise (number and time per week), measured at 4, 9, 26 and 52 weeks
11. Additional treatments Discipline and number of treatments, measured at 4, 9, 26 and 52 weeks
12. Side-effects (yes no and any additional elucidation), measured at 4, 9, 26 and 52 weeks
Overall trial start date
01/01/2004
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged between 18 and 70 years old
2. Have suffered from neck pain for over three months
3. Have an adequate knowledge of the Dutch language
Excluded are patients diagnosed with a specific disorder (e.g. a slipped disc, a tumour or a lesion in the cervical spine), those who have had physical/manual therapy during the previous six months, those with a chronic disease (e.g. rheumatoid arthritis or coronary artery disease), or those who have to undergo surgery in the near future.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80 per treatment group (160 total)
Participant exclusion criteria
1. Diagnosed with a specific disorder (e.g. a slipped disc, a tumour or a lesion in the cervical spine)
2. Have had physical/manual therapy during the previous six months
3. With a chronic disease (e.g. rheumatoid arthritis or coronary artery disease)
4. Who have to undergo surgery in the near future
Recruitment start date
01/01/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
PO Box 1738
Rotterdam
3000 DR
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (Netherlands)
Sponsor details
Dept. of General Practice
PO Box 1738
Rotterdam
3000 DR
Netherlands
+31 (0)10 4087613
b.koes@erasmusmc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
The Dutch Health Care Insurance Board (College voor zorgverzekeringen [CVZ]) (Netherlands) (ref: DPZ 01-01)
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. Protocol in: http://www.ncbi.nlm.nih.gov/pubmed/15469609
2. 2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/18692420
Publication citations
-
Protocol
Vonk F, Verhagen AP, Geilen M, Vos CJ, Koes BW, Effectiveness of behavioural graded activity compared with physiotherapy treatment in chronic neck pain: design of a randomised clinical trial [ISRCTN88733332]., BMC Musculoskelet Disord, 2004, 5, 1, 34, doi: 10.1186/1471-2474-5-34.
-
Results
Vonk F, Verhagen AP, Twisk JW, Köke AJ, Luiten MW, Koes BW, Effectiveness of a behaviour graded activity program versus conventional exercise for chronic neck pain patients., Eur J Pain, 2009, 13, 5, 533-541, doi: 10.1016/j.ejpain.2008.06.008.