Condition category
Musculoskeletal Diseases
Date applied
14/09/2004
Date assigned
15/09/2004
Last edited
15/04/2009
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 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

http://www.erasmusmc.nl/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes