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
Secondary identifying numbers	NTR493; 001

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

Dr Gerlienke Voerman
Scientific

Roessinghsbleekweg 33b
Enschede
7752 AH
Netherlands

Phone	+31 (0)53 4875728
Email	g.voerman@rrd.nl

Study design	Multicentre randomised open label active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
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	Pain intensity and disability
Secondary outcome measures	1. Health-related quality of life 2. Muscle activation patterns 3. Psychosocial characteristics
Overall study start date	01/04/2003
Completion date	01/10/2004

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	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

Roessinghsbleekweg 33b

Enschede
7752 AH
Netherlands

Roessingh Research and Development b.v. (The Netherlands)
Not defined

P.O. Box 310
Enschede
7500 AH
Netherlands

Charity

St. Hubert Foundation (Stichting St. Hubertus)

No information available

European New Project

No information available

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