Welcome
Support Centre
24 July 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Eccentric training for the prevention of injuries in the neck-shoulder region
ISRCTN ISRCTN16080194
DOI 10.1186/ISRCTN16080194
ClinicalTrials.gov identifier
EudraCT number
Public title Eccentric training for the prevention of injuries in the neck-shoulder region
Scientific title Neuromusculuar adaptations after 5 weeks of intensive eccentric neck-shoulder training: A randomised controlled trial
Acronym N/A
Serial number at source N/A
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.
Lay 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
Ethics approval The North Denmark Region Committee on Health Research Ethics, Denmark, July 2012, ref: N-20120036
Study design Randomised controlled trial
Countries of recruitment Denmark
Disease/condition/study domain Musculoskeletal disorders
Participants - inclusion criteria Healthy men and women between 18 and 40 years old
Participants - 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
Anticipated start date 01/11/2012
Anticipated end date 01/05/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 30
Interventions 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.
Primary outcome measure(s) 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 measure(s) 1. Muscle soreness, measured by visual analogue scale [VAS] and assessed before each training session
2. Compliance, measured at each training session
Sources of funding 1. Aalborg University (Denmark)
2. Rheumatism Association (Gigtforeningen) (Denmark)
3. The Ministry of Culture, Committee on Sports Research (Denmark)
4. The Danish Council for Independent Research, Technology and Production Sciences (Denmark) (ref: 10092821)
Trial website
Publications
Contact name Prof  Pascal  Madeleine
  Address Aalborg University
Dept. Health Science and Technology
Fredrik Bajers 7D
  City/town 9220
  Zip/Postcode 9220
  Country Denmark
  Email pm@hst.aau.dk
Sponsor Aalborg University (Denmark)
  Address Dept. of Health Science and Technology
Fredrik Bajers 7 D
  City/town Aalborg East
  Zip/Postcode 9220
  Country Denmark
  Sponsor website: http://www.smi.hst.aau.dk
Date applied 11/01/2013
Last edited 13/02/2013
Date ISRCTN assigned 13/02/2013
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.