Measuring the Feasibility and the Effects of Chair Massage on Pain and Discomfort in the Cardiac Sonographer

Tracking Information
First Submitted Date ICMJE	September 10, 2009
First Posted Date ICMJE	September 11, 2009
Last Update Posted Date	January 5, 2012
Study Start Date ICMJE	September 2008
Actual Primary Completion Date	December 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 10, 2009)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00975026 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 10, 2009)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Measuring the Feasibility and the Effects of Chair Massage on Pain and Discomfort in the Cardiac Sonographer
Official Title ICMJE	Measuring the Feasibility and the Effects of Chair Massage on Pain and Discomfort in the Cardiac Sonographer - A Pilot Study
Brief 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.
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Overuse Injury; Repetitive Strain Injury
Intervention ICMJE	Procedure: Massages ± Stretches; Chair Massage
Study Arms	Active Comparator: Massages Chair massage for 30 minutes once a week. Intervention: Procedure: Massages ± Stretches; Active Comparator: Massages + Stretches Chair massage for 30 minutes once a week in addition to stretching exercises, to be done twice daily for 20 minutes. Intervention: Procedure: Massages ± Stretches; No Intervention: No Intervention
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 10, 2009)	45
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	January 2009
Actual Primary Completion Date	December 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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; Pins or joint fusion of the head or neck; Current sinus infections, earaches, or vascular migraines; Students
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00975026
Other Study ID Numbers ICMJE	08-005517
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Deborah Engen, Mayo Clinic
Study Sponsor ICMJE	Mayo Clinic
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Deborah J. Engen, O.T. Mayo Clinic
PRS Account	Mayo Clinic
Verification Date	January 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP