Condition category
Musculoskeletal Diseases
Date applied
11/01/2013
Date assigned
13/02/2013
Last edited
13/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.smi.hst.aau.dk

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

Publication citations

Additional files

Editorial Notes