A Randomised Clinical Trial to evaluate the effects of a new treatment of chronic neck-shoulder pain in Work-related MusculoSkeletal Disorder (WMSD) patients - Ambulant Myofeedback training
| ISRCTN | ISRCTN54287166 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54287166 |
| Protocol serial number | NTR493; 001 |
| Sponsor | Roessingh Research and Development b.v. (The Netherlands) |
| Funders | St. Hubert Foundation (Stichting St. Hubertus), European New Project |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 17/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gerlienke Voerman
Scientific
Scientific
Roessinghsbleekweg 33b
Enschede
7752 AH
Netherlands
| Phone | +31 (0)53 4875728 |
|---|---|
| g.voerman@rrd.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised open label active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | NTR493; RCT Mfb |
| Study objectives | It is hypothesised that 4 weeks of ambulant myofeedback training is more effective in reducing pain intensity, disability, and normalising muscle activation patterns compared to traditional treatment of WMSD in the neck-shoulder region e.g. ergonomic counseling. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Work-related Musculoskeletal Disorders (WMSDs), Complaints of Arm, Neck and Shoulders (CANS) |
| Intervention | The intervention is 4 weeks ambulant myofeedback training. Control group receives traditional ergonomic counselling. |
| Intervention type | Other |
| Primary outcome measure(s) |
Pain intensity and disability |
| Key secondary outcome measure(s) |
1. Health-related quality of life |
| Completion date | 01/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 75 |
| Key inclusion criteria | 1. Elderly female subjects 2. Above the age of 35 years 3. Performing predominantly computer work 4. Reporting complaints in the neck and/or shoulder region for at least 30 days during the last year including the last 7 days 5. Subjectively relating complaints to (computer) work |
| Key exclusion criteria | 1. Severe cervical arthrosis 2. Other disorders in neck-shoulder region not related to WMSD 3. More than three body areas in which pain is reported 4. Colour blindness 5. Latex allergy 6. Use of muscle relaxants |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 01/10/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Roessinghsbleekweg 33b
Enschede
7752 AH
Netherlands
7752 AH
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 |
