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The purpose of this study is to describe the effects of massage therapy on quality of life (QOL) in youth and young adults (ages 8 to 21 years) with cystic fibrosis (CF).
Massage therapy (MT) is defined as hands on manipulation of the soft tissue of the body with the intent to produce therapeutic, physiologic effects and to promote health and well-being (Oawriter - OAC - codes.ohio.gov, 2010; American Massage Therapy Association, 2010). Quality of life is defined as a self-description (child or adult) or parent's description of the child's perceived health and well-being based on satisfaction with physical, emotional, psychosocial and school/role functioning (Varni et al., 2002). Additional measures for this study which may influence QOL include pain, pulmonary function, ease of breathing and thoracic excursion.
Research Questions:
i. What differences in changes of QOL scores, as measured by the Peds QL 4.0 (Pediatric Quality of Life Inventory) and the CFQ-R (Cystic Fibrosis Questionnaire - Revised) are found in youth and young adults with CF between the group receiving MT and control group? What changes in QOL scores in each group are found over time? ii. What differences in changes of musculoskeletal pain, as measured by the Numeric Rating Scale for pain are found in youth and young adults with CF between the group receiving MT and the control group? What changes in pain scores in each group are found over time? iii. What differences in changes of the pulmonary function are found in youth and young adults with CF between the group receiving MT and the control group in terms of the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | control group | |
| Massage therapy | Active Comparator | Treatment group receives pre-determined massage therapy protocol x 5 over 10-12 weeks. massage therapy protocol includes a blend of Swedish strokes and myofascial trigger point therapy. Initially, dosing will be more frequent. Treatments will be spaced out to determine the ability of the body to maintain a more efficient musculoskeletal system, especially related to respiratory and postural efforts. Each session will end with resting hands and relaxation strokes to signal the end of the session. This protocol invites increased mobility in the musculoskeletal system. The ultimate goal is to return connective tissue (including muscles and fascia) to a more relaxed and neutral state, thus allowing expansion and ease of movement of the areas of the musculoskeletal system being worked. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Massage Therapy | Procedure | The Massage Therapy protocol consists of a series of 5 massages administered over 10 (+2) weeks. Length of time for each visit will be approximately 1.5 - 2 hours Typically, a series of treatments over time allows the body time to integrate tissue related changes and potentially maintain a more healthy musculoskeletal state. Based on expert opinion in the field of MT, following a series of massage treatments administered over time, one can anticipate tissue changes. By adding time between treatments, data will describe the ability of subjects to maintain changes over progressively longer periods of time. Treatment protocol will be based on the application of myofascial trigger point therapy (Timberlake, 1999) to musculoskeletal areas of the body often affected by disease progression in CF. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life _Peds QOL and CFQ-R | standardized measures of quality of life will be administered to subject and to parents of subjects under 18 years of age. Muscle tightness, ease of breathing, and overall relaxation 0-10 scores captured subjective QOL data. | measured twice; visit 1 for baseline for treatment and control group and 10-12 weeks later following last treatment for treatment group, and same time frame for control group |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary function | Pulmonary function test will be obtained prior to first data collection visit, using clinical pft's for treatment and control groups. Clinical pft's will also be obtained for control group 10-12 weeks following first data set. For treatment group, research pft will be obtained following last massage 10-12 weeks following initial data collection. Ease of breathing will be measured pre and post each massage for treatment group and at time 1 and 2 for control group. Thoracic excursion will be measured pre and post each massage and x2 during each massage for treatment group, and at time 1 and 2 for control group. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Numeric rating scale will be used to assess pain. Pain Location and NRS Pain Score __Pre massage therapy __Post massage therapy __Follow-up phone call (date)_____ LOCATION OF PAIN NRS (0-10) Description of Pain (circle) Reported cause Start date Identify location and describe: sharp or dull; constant or intermittent Follow Up Phone Call for Pain Ask: "Are you having pain?" ___No ___Yes (If yes, ask the following questions and repeat for each location: "Where is your pain?" "On a scale of 0 to 10, 0 being no pain and 10 the worst pain you have ever had, rate your pain in your (location). How would you describe your pain in your (location)? Is it sharp like a stabbing knife or dull like an ache or pressure? Is it constant (is it steady and does not change?) or is it intermittent (does it come and go)? What do you think caused you to have pain in your (location)? When did this pain start?" |
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen A Zink, MSN | Cincinnati Children's Hospital, Division of Child Life and Integrative Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Zimmer, M., Bogenschutz, L., & Zink, K. (2008). Effect of massage therapy on pain in hospitalized pediatric cystic fibrosis patients. (abstract submitted to North American Research Conference on Complementary and Integrative Medicine, 2009). |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D008405 | Massage |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| pre treatment, prior to each massage, post treatment; Time 1 = initial data collection; collect data over 10-12 weeks for treatment group. For control group, time 1 is initial data collection; time 2 is 10-12 weeks later. |
| at time 1, obtain baseline pain score. Collect pain score pre and post each massage and 1-2 days following each massage. control group pain scores wil be obtained following timeframe for post massage data collection |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |