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

ISRCTN	ISRCTN87055459
DOI	https://doi.org/10.1186/ISRCTN87055459
Protocol serial number	KF 01-138/04
Sponsor	The National Research Centre for the Working Environment (Denmark)
Funders	Danish Medical Research Council (Denmark) (ref: 22-03-0264), The Danish Rheumatism Association (Denmark) (ref: 233-1149-02.02.04)

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 of protocol

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

Primary study design	Interventional
Study design	Case control and randomised cluster balanced interventional trial
Secondary study design	Case-control study
Scientific title
Study acronym	RAMIN (Rehabilitering Af Muskelsmerter I Nakken; Rehabilitating Activity for Myalgia In the Neck)
Study objectives	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).
Health condition(s) or problem(s) studied	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(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	80
Key inclusion criteria	1. Generally healthy female workers 2. Aged 30 - 60 years 3. With and without trapezius myalgia
Key exclusion criteria	1. Trauma 2. Generalised muscle pain 3. Life threatening diseases
Date of first enrolment	01/08/2005
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Denmark

Study participating centre

National Research Centre for the Working Environment

Copenhagen
DK-2100
Denmark

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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