Condition category
Injury, Occupational Diseases, Poisoning
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
17/08/2009
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

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

Publication citations

Additional files

Editorial Notes