Musculoskeletal DisordersNCT01478451
Acute Effect of Massage and Exercise on Muscle Tenderness
A study testing Exercise and Massage in people with Musculoskeletal Disorders, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
Trial summary
Many people experience pain, tenderness and soreness of joint and muscles, both in sport and working life. Pain killers can provide acute relief of pain, but may not be a feasible solution for all people. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Disorders
- What is being tested?
- Exercise and Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- working age adults
Who cannot join
- blood pressure above 160/100
- disease of the cervical spine
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National Research Centre for the Working Environment
Copenhagen, 2100
About this study
Official title: Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace
Many people experience pain, tenderness and soreness of joint and muscles, both in sport and working life. Pain killers can provide acute relief of pain, but may not be a feasible solution for all people. Here the investigators examine the acute effect of massage and exercise on induced muscle tenderness (delayed onset muscular soreness).
- Conditions
- Musculoskeletal Disorders
- Being tested
- Exercise, Massage
- Keywords
- DOMS
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise will be performed for 10 minutes at the left or right trapezius (randomized)
MassageOther
massage will be provided for 10 minutes at the left or right trapezius (randomized)
| Study group | Role | What they receive |
|---|---|---|
| Massage | Experimental | massage will be provided for 10 minutes at the left or right trapezius (randomized) Receives: Other: Massage |
| Exercise | Experimental | exercise (shoulder shrugs with elastic resistance) will be performed for 10 minutes at the left or right trapezius (randomized) Receives: Behavioral: Exercise |
| Control | No intervention | control shoulder (randomized) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived tenderness of the trapezius muscle on a numerical rating scale of 0-10
Perceived tenderness where 0 is no tenderness and 10 is worst imaginable tenderness
Measured: change from before to after the acute intervention (average of 0, 10, 20 and 60 min after the intervention)
Pressure pain threshold of the trapezius muscle
Measured: change from before to after the acute intervention (average of 0, 10, 20 and 60 min after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre for the Working Environment, Denmark
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lars L. Andersen, National Research Centre for the Working Environment, Denmark
- Investigators
- Lars L Andersen, PhD, Principal investigator, Senior Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478451
- Sponsor's protocol ID
- IRMA02
- Status last verified
- Feb 2012
- First submitted
- 28 Oct 2011
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Andersen LL, Jay K, Andersen CH, Jakobsen MD, Sundstrup E, Topp R, Behm DG. Acute effects of massage or active exercise in relieving muscle soreness: randomized controlled trial. J Strength Cond Res. 2013 Dec;27(12):3352-9. doi: 10.1519/JSC.0b013e3182908610.
PubMed 23524365
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace
- ClinicalTrials.gov ID
- NCT01478451
- Acronym / sponsor ID
- IRMA02
- Conditions
- Musculoskeletal Disorders
- Keywords
- DOMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many people experience pain, tenderness and soreness of joint and muscles, both in sport and working life. Pain killers can provide acute relief of pain, but may not be a feasible solution for all people. Here the investigators examine the acute effect of massage and exercise on induced muscle tenderness (delayed onset muscular soreness).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Other: Massagemassage will be provided for 10 minutes at the left or right trapezius (randomized) |
| Exercise | Experimental | Behavioral: Exerciseexercise (shoulder shrugs with elastic resistance) will be performed for 10 minutes at the left or right trapezius (randomized) |
| Control | No intervention | –control shoulder (randomized) |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- working age adults
Key exclusion criteria (2 listed)
- blood pressure above 160/100
- disease of the cervical spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise will be performed for 10 minutes at the left or right trapezius (randomized) | Behavioural | Exercise |
| Massagemassage will be provided for 10 minutes at the left or right trapezius (randomized) | Other | Massage |
Primary outcome
Perceived tenderness of the trapezius muscle on a numerical rating scale of 0-10
Time frame: change from before to after the acute intervention (average of 0, 10, 20 and 60 min after the intervention)
Perceived tenderness where 0 is no tenderness and 10 is worst imaginable tenderness
Pressure pain threshold of the trapezius muscle
Time frame: change from before to after the acute intervention (average of 0, 10, 20 and 60 min after the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
- Derived from this study: PubMed 23524365Andersen LL, Jay K, Andersen CH, Jakobsen MD, Sundstrup E, Topp R, Behm DG. Acute effects of massage or active exercise in relieving muscle soreness: randomized controlled trial. J Strength Cond Res. 2013 Dec;27(12):3352-9. doi: 10.1519/JSC.0b013e3182908610.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars L Andersen, PhD principal investigator
Senior Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Massage in people with Musculoskeletal Disorders, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived tenderness of the trapezius muscle on a numerical rating scale of 0-10 (time frame: change from before to after the acute intervention (average of 0, 10, 20 and 60 min after the intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01478451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012.