Effectiveness of behavioural graded activity compared with physiotherapy treatment in chronic neck pain: a randomised clinical trial

ISRCTN	ISRCTN88733332
DOI	https://doi.org/10.1186/ISRCTN88733332
Protocol serial number	N/A
Sponsor	Erasmus Medical Centre (Netherlands)
Funder	The Dutch Health Care Insurance Board (College voor zorgverzekeringen [CVZ]) (Netherlands) (ref: DPZ 01-01)

Submission date: 14/09/2004
Registration date: 15/09/2004
Last edited: 15/04/2009

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 Bart Koes
Scientific

PO Box 1738
Rotterdam
3000 DR
Netherlands

Phone	+31 (0)10 4087620
Email	b.koes@erasmusmc.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Ephysion (Effectiveness Physiotherapy in Neck pain)
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	'Global perceived effect' (neck complaint and functioning in daily activities) (1 - 7 on the Likert scale), measured at 4, 9, 26 and 52 weeks.
Key secondary outcome measure(s)	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
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	160
Key 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.
Key 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
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

PO Box 1738

Rotterdam
3000 DR
Netherlands

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2009		Yes	No
Protocol article	Protocol	06/10/2004		Yes	No