Condition category
Musculoskeletal Diseases
Date applied
21/02/2007
Date assigned
14/03/2007
Last edited
11/06/2010
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

Prof Gisela Sjøgaard

ORCID ID

Contact details

National Research Centre for the Working Environment
Lersø Parkalle 105
Copenhagen
DK-2100
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KF 01-138/04

Study information

Scientific title

Acronym

RAMIN (Rehabilitering Af Muskelsmerter I Nakken; Rehabilitating Activity for Myalgia In the Neck)

Study hypothesis

1. Metabolic and morphological differences exist in the trapezius muscle among female workers with and without neck/shoulder myalgia
2. Physical activity in terms of dynamic resistance training and bicycle training will via different mechanisms relieve pain and modulate muscle metabolism and morphology of the trapezius muscle in female workers with neck/shoulder myalgia

Ethics approval

Ethics approval received from the Local Ethical Committee of Copenhagen, Denmark (ref: KF 01-138/04).

Study design

Case control and randomised cluster balanced interventional trial

Primary study design

Interventional

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Musculoskeletal Disorders

Intervention

Intervention amended as of 22/08/2007:
Participants are randomised to receive one of the following:
1. Dynamic resistance training: 20 minutes per session, three times a week, for 10 weeks supervised by an instructor
2. Leg bicycle training: 20 minutes per session, three times a week, for 10 weeks supervised by an instructor
3. Health promoting information but no physical training

Interventions provided at time of registration:
Participants are randomised to receive one of the following:
1. Dynamic resistance training
2. Leg bicycle training
3. Health promoting information but no physical training

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Primary outcome measures amended as of 22/08/2007:
The following will be assessed at baseline before the intervention and again immediately after the 10-week intervention training:
1. Perceived pain
2. Clinical findings
3. Muscle strength and function

Primary outcome measures provided at time of registration:
1. Perceived pain
2. Clinical findings
3. Muscle strength and function

Secondary outcome measures

Secondary outcome measures amended as of 22/08/2007:
The following will be assessed at baseline before the intervention and again immediately after the 10-week intervention training:
1. Muscle biochemistry and histochemistry
2. Microdialysis
3. Ultrasound
4. Electromyography (EMG)
5. Near infrared spectroscopy (NIRS)
6. Exercise test performance

Secondary outcome measures provided at time of registration:
1. Muscle biochemistry and histochemistry
2. Microdialysis
3. Ultrasound
4. Electromyography (EMG)
5. Near infrared spectroscopy (NIRS)
6. Exercise test performance

Overall trial start date

01/08/2005

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Generally healthy female workers
2. Aged 30 - 60 years
3. With and without trapezius myalgia

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

20 without and 60 with trapezius myalgia

Participant exclusion criteria

1. Trauma
2. Generalised muscle pain
3. Life threatening diseases

Recruitment start date

01/08/2005

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Denmark

Trial participating centre

National Research Centre for the Working Environment
Copenhagen
DK-2100
Denmark

Sponsor information

Organisation

The National Research Centre for the Working Environment (Denmark)

Sponsor details

Lersø Parkalle 105
Copenhagen Ø
DK 2100
Denmark

Sponsor type

Government

Website

http://www.arbejdsmiljoforskning.dk/

Funders

Funder type

Government

Funder name

Danish Medical Research Council (Denmark) (ref: 22-03-0264)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Danish Rheumatism Association (Denmark) (ref: 233-1149-02.02.04)

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

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18163419
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20513105

Publication citations

  1. Results

    Andersen LL, Kjaer M, Søgaard K, Hansen L, Kryger AI, Sjøgaard G, Effect of two contrasting types of physical exercise on chronic neck muscle pain., Arthritis Rheum., 2008, 59, 1, 84-91, doi: 10.1002/art.23256.

  2. Results

    Nielsen PK, Andersen LL, Olsen HB, Rosendal L, Sjøgaard G, Søgaard K, Effect of physical training on pain sensitivity and trapezius muscle morphology., Muscle Nerve, 2010, 41, 6, 836-844, doi: 10.1002/mus.21577.

Additional files

Editorial Notes