Overuse InjuryNCT00975026
Measuring the Feasibility and the Effects of Chair Massage on Pain and Discomfort in the Cardiac Sonographer
A study testing Massages ± Stretches in people with Overuse Injury and Repetitive Strain Injury, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the effects of chair massage and/or chair massage with stretching may reduce musculoskeletal pain and discomfort related symptoms associated with the job duties of a cardiac sonographer. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overuse Injury, Repetitive Strain Injury
- What is being tested?
- Massages ± Stretches
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jan 2009
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cardiac Sonographer that, per their job descriptions, are performing echocardiography exams during the weeks of the massage therapy pilot study.
- Men and Women age 18-65 able to give informed consent.
- Able to speak and understand English
- 8-hour per day shift schedule, Monday through Friday
Who cannot join
- Individuals that decline to participate in the study.
- Individuals being treated for an acute musculoskeletal symptom.
- Individuals currently on work restrictions.
- Undergoing treatments for malignancy
- Pregnancy (due to this being chair massage)
- Recent head, neck, shoulder or back surgeries
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- Pins or joint fusion of the head or neck
- Current sinus infections, earaches, or vascular migraines
- Students
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring the Feasibility and the Effects of Chair Massage on Pain and Discomfort in the Cardiac Sonographer - A Pilot Study
The purpose of this study is to determine whether the effects of chair massage and/or chair massage with stretching may reduce musculoskeletal pain and discomfort related symptoms associated with the job duties of a cardiac sonographer.
Read the detailed description
Staff performing echocardiography exams work in a physically demanding environment. The physical and psychosocial demands of the work environment place a significant amount of stress on the physical well being of the employee. The nature of the work involved includes repetitive movements and static holds while applying intense pressure. These compounded by a challenging ergonomic work environment, often leads to physical tension, pain, and fatigue. Staff and patient characteristics, in particular obesity, present greater ergonomic challenges. In this setting, optimal ergonomics can be difficult to achieve. Repetitive actions in an ergonomically challenging environment can have an accumulative effect that can lead to injury.
Massage therapy has been noted to decrease levels of anxiety and fatigue which is essential to maintaining efficient care in a dynamic environment. Repetitive use, typically leads to shortened, tight muscles that fatigue over time. Once the massage therapy has released the connective tissue tension and restored muscle imbalances, exercise focused on core, trunk strength and those muscles which oppose the repetitively used muscles can further assist the therapeutic benefits of massage.
The cardiac sonographer is usually sitting and reaching forward or to the side, and the musculoskeletal imbalances show up primarily superior to the hips. Massage Therapy research for alleviating musculoskeletal symptoms has been with the use of table massage whereas chair massage research has focused on gaining physiological benefits. Chair massage therapy impacts the head, back, neck shoulders, arms and hands so does impact the areas of musculoskeletal imbalance of the cardiac sonographer. In addition, a massage chair is easy to set up, does not need a great deal of space, and can be provided in semi-private area, as the participant remains clothed. Chair massage literature to date has focused more on physiological responses and albeit positive, not as much on musculoskeletal responses.
- Conditions
- Overuse Injury, Repetitive Strain Injury
- Being tested
- Massages ± Stretches
- Keywords
- Massage, Chair Massage, Pain, Discomfort, Stretching, Stretching Exercises, Sonographer, Cardiac Sonographer
- Medical subject headings
- Cumulative Trauma Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massages ± StretchesProcedure or surgery
Chair Massage
| Study group | Role | What they receive |
|---|---|---|
| Massages | Active comparator | Chair massage for 30 minutes once a week. Receives: Procedure: Massages ± Stretches |
| Massages + Stretches | Active comparator | Chair massage for 30 minutes once a week in addition to stretching exercises, to be done twice daily for 20 minutes. Receives: Procedure: Massages ± Stretches |
| No Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the ease and feasibility of providing chair massage therapy in a busy echocardiography exam setting. Compare and contrast the level of pain and discomfort in cardiac sonography staff with three groups over three different time frames.
Measured: 10 Weeks
Secondary outcomes (2)
Assess the impact on co-workers as massage therapy is provided during the workday and its effects on workflow.
Measured: 10 Weeks
Compare the level of fatigue, stress, anxiety, and relaxation in cardiac sonography staff in each of the 3-arms of the study.
Measured: 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionJan 2009
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 Overuse InjuryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Engen, Mayo Clinic
- Investigators
- Deborah J. Engen, O.T., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975026
- Sponsor's protocol ID
- 08-005517
- Status last verified
- Jan 2012
- First submitted
- 10 Sep 2009
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Engen DJ, Wahner-Roedler DL, Nadolny AM, Persinger CM, Oh JK, Spittell PC, Loehrer LL, Cha SS, Bauer BA. The effect of chair massage on muscular discomfort in cardiac sonographers: a pilot study. BMC Complement Altern Med. 2010 Sep 16;10:50. doi: 10.1186/1472-6882-10-50.
PubMed 20846441
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Feasibility and the Effects of Chair Massage on Pain and Discomfort in the Cardiac Sonographer - A Pilot Study
- ClinicalTrials.gov ID
- NCT00975026
- Acronym / sponsor ID
- 08-005517
- Conditions
- Overuse Injury, Repetitive Strain Injury
- Keywords
- Massage, Chair Massage, Pain, Discomfort, Stretching, Stretching Exercises, Sonographer, Cardiac Sonographer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 11 Sep 2009 (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.
The purpose of this study is to determine whether the effects of chair massage and/or chair massage with stretching may reduce musculoskeletal pain and discomfort related symptoms associated with the job duties of a cardiac sonographer.
Detailed description
Staff performing echocardiography exams work in a physically demanding environment. The physical and psychosocial demands of the work environment place a significant amount of stress on the physical well being of the employee. The nature of the work involved includes repetitive movements and static holds while applying intense pressure. These compounded by a challenging ergonomic work environment, often leads to physical tension, pain, and fatigue. Staff and patient characteristics, in particular obesity, present greater ergonomic challenges. In this setting, optimal ergonomics can be difficult to achieve. Repetitive actions in an ergonomically challenging environment can have an accumulative effect that can lead to injury.
Massage therapy has been noted to decrease levels of anxiety and fatigue which is essential to maintaining efficient care in a dynamic environment. Repetitive use, typically leads to shortened, tight muscles that fatigue over time. Once the massage therapy has released the connective tissue tension and restored muscle imbalances, exercise focused on core, trunk strength and those muscles which oppose the repetitively used muscles can further assist the therapeutic benefits of massage.
The cardiac sonographer is usually sitting and reaching forward or to the side, and the musculoskeletal imbalances show up primarily superior to the hips. Massage Therapy research for alleviating musculoskeletal symptoms has been with the use of table massage whereas chair massage research has focused on gaining physiological benefits. Chair massage therapy impacts the head, back, neck shoulders, arms and hands so does impact the areas of musculoskeletal imbalance of the cardiac sonographer. In addition, a massage chair is easy to set up, does not need a great deal of space, and can be provided in semi-private area, as the participant remains clothed. Chair massage literature to date has focused more on physiological responses and albeit positive, not as much on musculoskeletal responses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Massages | Active comparator | Procedure: Massages ± StretchesChair massage for 30 minutes once a week. |
| Massages + Stretches | Active comparator | Procedure: Massages ± StretchesChair massage for 30 minutes once a week in addition to stretching exercises, to be done twice daily for 20 minutes. |
| No Intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cardiac Sonographer that, per their job descriptions, are performing echocardiography exams during the weeks of the massage therapy pilot study.
- Men and Women age 18-65 able to give informed consent.
- Able to speak and understand English
- 8-hour per day shift schedule, Monday through Friday
Key exclusion criteria (9 listed)
- Individuals that decline to participate in the study.
- Individuals being treated for an acute musculoskeletal symptom.
- Individuals currently on work restrictions.
- Undergoing treatments for malignancy
- Pregnancy (due to this being chair massage)
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 |
|---|---|---|
| Massages ± StretchesChair Massage | Procedure or surgery | Massages, Massages + Stretches |
Primary outcome
Assess the ease and feasibility of providing chair massage therapy in a busy echocardiography exam setting. Compare and contrast the level of pain and discomfort in cardiac sonography staff with three groups over three different time frames.
Time frame: 10 Weeks
2 secondary outcomes
Assess the impact on co-workers as massage therapy is provided during the workday and its effects on workflow.
Time frame: 10 Weeks
Compare the level of fatigue, stress, anxiety, and relaxation in cardiac sonography staff in each of the 3-arms of the study.
Time frame: 10 Weeks
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 5 Jan 2012.
- Results publication: PubMed 20846441Engen DJ, Wahner-Roedler DL, Nadolny AM, Persinger CM, Oh JK, Spittell PC, Loehrer LL, Cha SS, Bauer BA. The effect of chair massage on muscular discomfort in cardiac sonographers: a pilot study. BMC Complement Altern Med. 2010 Sep 16;10:50. doi: 10.1186/1472-6882-10-50.
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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.
Deborah J. Engen, O.T. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massages ± Stretches in people with Overuse Injury and Repetitive Strain Injury, run by Mayo Clinic at 1 site in United States.
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 4 inclusion and 9 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 5 Jan 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 United States. 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?
Assess the ease and feasibility of providing chair massage therapy in a busy echocardiography exam setting. Compare and contrast the level of pain and discomfort in cardiac sonography staff with three groups over three different time frames. (time frame: 10 Weeks). 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 NCT00975026, 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 5 Jan 2012.