Intramuscular mechanisms underlying work related trapezius muscle pain - physical activity as intervention for rehabilitation

ISRCTN	ISRCTN87055459
DOI	https://doi.org/10.1186/ISRCTN87055459
Secondary identifying numbers	KF 01-138/04

Submission date: 21/02/2007
Registration date: 14/03/2007
Last edited: 11/06/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Gisela Sjøgaard
Scientific

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

Study information

Study design	Case control and randomised cluster balanced interventional trial
Primary study design	Interventional
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study 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(s)	Ethics approval received from the Local Ethical Committee of Copenhagen, Denmark (ref: KF 01-138/04).
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
Primary outcome measure	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 study start date	01/08/2005
Overall study end date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	20 without and 60 with trapezius myalgia
Participant inclusion criteria	1. Generally healthy female workers 2. Aged 30 - 60 years 3. With and without 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

Study participating centre

National Research Centre for the Working Environment

Copenhagen
DK-2100
Denmark

Sponsor information

The National Research Centre for the Working Environment (Denmark)
Government

Lersø Parkalle 105
Copenhagen Ø
DK 2100
Denmark

Website	http://www.arbejdsmiljoforskning.dk/
"ROR"	https://ror.org/03f61zm76

Funders

Funder type

Government

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

No information available

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

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/01/2008		Yes	No
Results article	results	01/06/2010		Yes	No