Contact information
Type
Scientific
Primary contact
Dr Gerlienke Voerman
ORCID ID
Contact details
Roessinghsbleekweg 33b
Enschede
7752 AH
Netherlands
+31 (0)53 4875728
g.voerman@rrd.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR493; 001
Study information
Scientific title
Acronym
NTR493; RCT Mfb
Study hypothesis
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
Received from local medical ethics committee
Study design
Multicentre randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Pain intensity and disability
Secondary outcome measures
1. Health-related quality of life
2. Muscle activation patterns
3. Psychosocial characteristics
Overall trial start date
01/04/2003
Overall trial end date
01/10/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
75
Participant 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
Recruitment start date
01/04/2003
Recruitment end date
01/10/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
Roessinghsbleekweg 33b
Enschede
7752 AH
Netherlands
Sponsor information
Organisation
Roessingh Research and Development b.v. (The Netherlands)
Sponsor details
P.O. Box 310
Enschede
7500 AH
Netherlands
+31 (0)53 4875777
info@rrd.nl
Sponsor type
Not defined
Website
Funders
Funder type
Charity
Funder name
St. Hubert Foundation (Stichting St. Hubertus)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
European New Project
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