Plain English Summary
Background and study aims
The purpose of this study is to investigate the effects of a training program based on eccentric exercises of the shoulder and neck muscles. Eccentric exercises are characterized by the following: the muscle that is trained is extended, while it is producing power. Previous studies have shown that exercise can reduce the pain intensity in people with neck/shoulder disorders. However, the effects of this type of exercise on the neuro-muscular system are unclear. Thus, it is necessary to investigate the effects of eccentric exercise. This will in turn enable to define better treatment strategy for the prevention of neck/shoulder disorders.
Who can participate?
Healthy men and women with no previous disorders in the neck-shoulder region.
What does the study involve?
Participants will be randomly allocated to one of two groups: a training group and a control group (no training). Subjects in the training group perform strength training for 5 weeks, twice a week. Each training session will last 30 to 60 minutes and take place at the Center for Sensory-Motor Interaction, Aalborg (Denmark). Both groups will be tested in three sessions: before the start of training, after 3 weeks of training and after completion of the training (approx. 2 hours per session). At these sessions, electrical stimuli are applied to the neck region (not painful). The maximum strength in the neck and shoulder muscles will be also be measured.
What are the possible benefits and risks of participating?
After completion of the training program it is expected that subjects will experience an improvement, which can positively influence their health and wellbeing.
The new knowledge gained which be able to contribute to the treatment and prevention of musculoskeletal disorders.
There are no known serious risks with the methods employed in the present study, which are routinely used at the Center for Sensory-Motor Interaction and at a lot of other research institutions throughout the world.
Where is the study run from?
Center for Sensory-Motor Interaction, Aalborg (Denmark).
When is the study starting and how long is it expected to run for?
The project will run from November 2012 to May 2013.
Who is funding the study?
Aalborg University (Denmark)
Rheumatism Association (Gigtforeningen) (Denmark)
The Ministry of Culture, Committee on Sports Research (Denmark)
The Danish Council for Independent Research, Technology and Production Sciences (Denmark)
Who is the main contact
PhD student Steffen Vangsgaard, sv@hst.aau.dk
Professor Pascal Madeleine, pm@hst.aau.dk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Pascal Madeleine
ORCID ID
Contact details
Aalborg University
Dept. Health Science and Technology
Fredrik Bajers 7D
9220
9220
Denmark
pm@hst.aau.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Neuromusculuar adaptations after 5 weeks of intensive eccentric neck-shoulder training: A randomised controlled trial
Acronym
Study hypothesis
Participants in the training group will have:
1. Increased strength
2. Higher H reflex amplitudes, and
3. Different activation of neck-shoulder muscles compared to a control group after the training intervention.
Ethics approval
The North Denmark Region Committee on Health Research Ethics, Denmark, July 2012, ref: N-20120036
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Musculoskeletal disorders
Intervention
Subjects randomised to the training group will train 2 times per week for 5 weeks of intensive eccentric training for the neck-shoulder muscles.
Participants randomised to the control group will not train.
The intervention will last 5 weeks.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Muscle strength, measured using a dynamometer and assessed three times: before intervention, after 2 weeks, and after the intervention period.
2. H reflex amplitude, elicited by electrical stimulation and measured three times: before intervention, after 2 weeks, and after the intervention period.
3. Muscle activity and coordination, measured by surface electromyography [EMG] and assessed three times: before intervention, after 2 weeks, and after the intervention period.
Secondary outcome measures
1. Muscle soreness, measured by visual analogue scale [VAS] and assessed before each training session
2. Compliance, measured at each training session
Overall trial start date
01/11/2012
Overall trial end date
01/05/2013
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy men and women between 18 and 40 years old
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Current or previous pain in the neck/shoulder/arm
2. Regular strength training within 12 months before the study
3. Consumption of alcohol or pain-relieving drugs 24h prior to the experiment
4. Pregnancy
5. Hypertension (>160/>100 mmHg) and heart diseases
6. Addictive or previous addictive behavior defined as the abuse of cannabis, opioids or other drugs
7. Previous neurological or mental disorders
8. Inability to cooperate
Recruitment start date
01/11/2012
Recruitment end date
01/05/2013
Locations
Countries of recruitment
Denmark
Trial participating centre
Aalborg University
9220
9220
Denmark
Sponsor information
Organisation
Aalborg University (Denmark)
Sponsor details
Dept. of Health Science and Technology
Fredrik Bajers 7 D
Aalborg East
9220
Denmark
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Aalborg University (Denmark)
Alternative name(s)
Aalborg University
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Denmark
Funder name
Rheumatism Association (Gigtforeningen) (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Ministry of Culture, Committee on Sports Research (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Danish Council for Independent Research, Technology and Production Sciences (Denmark) (ref: 10092821)
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