The Effects of Massage Therapy on QOL in Youth/Young Adults With Cystic Fibrosis
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effects of Massage Therapy on Quality of Life in Youth and Young Adults With Cystic Fibrosis: A Pilot Study|
- Quality of life _Peds QOL and CFQ-R [ Time Frame: 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 ] [ Designated as safety issue: No ]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.
- Pulmonary function [ Time Frame: 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. ] [ Designated as safety issue: No ]
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.
- Pain [ Time Frame: 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 ] [ Designated as safety issue: No ]
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?"
|Study Start Date:||July 2013|
|Study Completion Date:||March 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
No Intervention: control group
Active Comparator: Massage therapy
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.
Procedure: Massage Therapy
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.
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.
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:
- Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC) scores,
- Single breath counting score, measuring ease of breathing, and
- Thoracic excursion as measured by the cloth tape measure technique? What changes in the above pulmonary function in each group are found over time?
Please refer to this study by its ClinicalTrials.gov identifier: NCT01729585
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Kathleen A Zink, MSN||Cincinnati Children's Hospital, Division of Child Life and Integrative Care|