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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
PO Box 1738
Rotterdam
3000 DR
Netherlands
| Phone | +31 (0)10 4087620 |
|---|---|
| b.koes@erasmusmc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | '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 study start date | 01/01/2004 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 per treatment group (160 total) |
| 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
3000 DR
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Dept. of General Practice
PO Box 1738
Rotterdam
3000 DR
Netherlands
| Phone | +31 (0)10 4087613 |
|---|---|
| b.koes@erasmusmc.nl | |
| Website | http://www.erasmusmc.nl/ |
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Government
The Dutch Health Care Insurance Board (College voor zorgverzekeringen [CVZ]) (Netherlands) (ref: DPZ 01-01)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 06/10/2004 | Yes | No | |
| Results article | results | 01/05/2009 | Yes | No |
