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
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
-
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.