Musculoskeletal DisordersIRMANCT01478464
Effect of Massage on Hamstring Muscle Soreness
A study testing Massage in people with Musculoskeletal Disorders, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
Trial summary
Delayed onset muscular soreness peaks in 24-48 hours after unaccustomed strenuous physical exercise. Therapists often provide manual massage with the hands to acutely relief the soreness. Alternatives to manual hand massage can be useful for therapists. Read more about this study
- Who is it for?
- Ages 18 to 67 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Disorders
- What is being tested?
- Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2011to Nov 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
- Men only
- 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, Copenhagen, 2100
About this study
Official title: Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace
Delayed onset muscular soreness peaks in 24-48 hours after unaccustomed strenuous physical exercise. Therapists often provide manual massage with the hands to acutely relief the soreness. Alternatives to manual hand massage can be useful for therapists. Here the investigators examine the acute effect of a "massage roller" on DOMS in the hamstring muscles
- Conditions
- Musculoskeletal Disorders
- Being tested
- Massage
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
The hamstring muscle will be massaged with a "massage roller" for ten minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group, does not receive any intervention |
| Massage group | Experimental | Massage will be performed on the left or right hamstring muscle (randomized) for ten minutes with a massage roller. The contralateral leg will not be massaged, but serve as a non-massaged control leg to assess possible cross-over effects from the massaged leg Receives: Other: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived soreness on a scale of 0-10
0: no soreness 10: worst imaginable soreness
Measured: change from before to after massage (average of 0, 10, 30 and 60 min after)
Secondary outcomes (2)
Pressure pain threshold (PPT) of the hamstring muscles
Measured: change from before to after massage (average of 0, 10, 30 and 60 min after)
Hamstring range of motion
Measured: change from before to after massage (average of 0, 10, 30 and 60 min after)
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 startDec 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 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, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478464
- Sponsor's protocol ID
- IRMA03
- Acronym
- IRMA
- Status last verified
- Jun 2013
- First submitted
- 18 Nov 2011
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. 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
- NCT01478464
- Acronym / sponsor ID
- IRMA / IRMA03
- Conditions
- Musculoskeletal Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Study start
- Dec 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 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.
Delayed onset muscular soreness peaks in 24-48 hours after unaccustomed strenuous physical exercise. Therapists often provide manual massage with the hands to acutely relief the soreness. Alternatives to manual hand massage can be useful for therapists. Here the investigators examine the acute effect of a "massage roller" on DOMS in the hamstring muscles
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group, does not receive any intervention |
| Massage group | Experimental | Other: MassageMassage will be performed on the left or right hamstring muscle (randomized) for ten minutes with a massage roller. The contralateral leg will not be massaged, but serve as a non-massaged control leg to assess possible cross-over effects from the massaged leg |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- Male only
- 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 |
|---|---|---|
| MassageThe hamstring muscle will be massaged with a "massage roller" for ten minutes. | Other | Massage group |
Primary outcome
Perceived soreness on a scale of 0-10
Time frame: change from before to after massage (average of 0, 10, 30 and 60 min after)
0: no soreness 10: worst imaginable soreness
2 secondary outcomes
Pressure pain threshold (PPT) of the hamstring muscles
Time frame: change from before to after massage (average of 0, 10, 30 and 60 min after)
Hamstring range of motion
Time frame: change from before to after massage (average of 0, 10, 30 and 60 min after)
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 Jun 2013.
- 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
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 Jun 2013. 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 soreness on a scale of 0-10 (time frame: change from before to after massage (average of 0, 10, 30 and 60 min after)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2013.