Condition category
Musculoskeletal Diseases
Date applied
28/07/2009
Date assigned
18/09/2009
Last edited
20/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lars L Andersen

ORCID ID

Contact details

Lersø Parkalle 105
Copenhagen
2100
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Dose-response of specific strength training for rehabilitation of neck/shoulder muscle pain: a randomised single-blind controlled trial

Acronym

Study hypothesis

Participants randomised to specific strength training for 5 x 2 minutes per week and 5 x 12 minutes per week will report better relief of neck/shoulder muscle pain compared with a control group.

Ethics approval

Local Ethical Committee of Copenhagen and Frederiksberg, Denmark, approved in November 2008 (ref: HC-2008-103). Approval of supplementary protocol: 9th March 2009.

Study design

Randomised single-blind controlled intervention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Musculoskeletal disorders

Intervention

The intervention will last 10 weeks. Employees randomised to specific strength training will be offered 5 x 2 minutes per week or 5 x 12 minutes per week for 10 weeks of specific strength training for the neck/shoulder muscles. Participants randomised to the control group will receive information on various aspects of general health.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Subjective pain, measured weekly throughout the 10 week intervention period
2. Clinical findings, measured twice; before and after the intervention period
3. Muscle strength, measured twice; before and after the intervention period

Secondary outcome measures

1. Other subjective health complaints, measured twice; before and after the intervention period
2. Compliance, measured weekly throughout the 10 week intervention period

Overall trial start date

01/08/2009

Overall trial end date

15/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Generally healthy workers
2. Aged 25 - 65 years, either sex
3. Palpable tenderness of the neck/shoulder muscles
4. An anamnestic history of neck/shoulder pain for at least 30 days during last year
5. Reported neck/shoulder pain intensity of at least 2 on a scale of 0 - 10

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Trauma
2. Pregnancy
3. Life threatening diseases
4. Blood pressure above 160/100 mmHg
5. Other known serious disorders, e.g. fibromyalgia or rheumatoid arthritis

Recruitment start date

01/08/2009

Recruitment end date

15/12/2009

Locations

Countries of recruitment

Denmark

Trial participating centre

Lersø Parkalle 105
Copenhagen
2100
Denmark

Sponsor information

Organisation

The National Research Centre for the Working Environment (Denmark)

Sponsor details

Lersø Parkalle 105
Copenhagen
2100
Denmark

Sponsor type

Research organisation

Website

http://www.arbejdsmiljoforskning.dk

Funders

Funder type

Research organisation

Funder name

The National Research Centre for the Working Environment (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Danish Rheumatism Association (Denmark) (ref: R68-A993)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hygenic Corporation (USA)

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22996850

Publication citations

  1. Results

    Andersen LL, Andersen CH, Sundstrup E, Jakobsen MD, Mortensen OS, Zebis MK, Central adaptation of pain perception in response to rehabilitation of musculoskeletal pain: randomized controlled trial., Pain Physician, 15, 5, 385-394.

Additional files

Editorial Notes