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The Effects of Massage Therapy on QOL in Youth/Young Adults With Cystic Fibrosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01729585
First received: November 15, 2012
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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:

  1. Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC) scores,
  2. Single breath counting score, measuring ease of breathing, and
  3. Thoracic excursion as measured by the cloth tape measure technique? What changes in the above pulmonary function in each group are found over time?

Condition Intervention
Cystic Fibrosis
Quality of Life
Procedure: Massage Therapy

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Other Outcome Measures:
  • 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?"



Estimated Enrollment: 24
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group
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 MT 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.

  Eligibility

Ages Eligible for Study:   8 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion Criteria:

  • Diagnosis of CF evidenced by a prior documented positive sweat test (>60 mEq/ml by quantitative pilocarpine iontophoresis and genotype with two identified mutations consistent with CF)
  • Males and females, aged 8 to 21 years at time of enrollment to obtain a broad range of symptoms related to tissue changes. (Over time, individuals with CF present with increasing symptoms with age and disease progression.)
  • English speaking
  • Pulmonary function clinical baseline <100% (Baseline is defined as the highest PFT during the 6 months prior to PFT at enrollment.)
  • Clinically stable as defined by no evidence of acute upper or lower respiratory tract infections or other acute illnesses requiring use of antibiotics for at least 14 days prior to enrollment. (Pulmonary exacerbation often includes cough which may affect responses to MT.)
  • Approval to participate from Pulmonary Physician
  • Informed consent to participate

Exclusion Criteria:

  • Exposed to any investigational drug or device within 30 days of enrollment
  • Any other illness at time of enrollment not a direct result of CF that the pulmonary physician determines that MT is contraindicated
  • Inability to lay flat on massage table as is required for massage protocol
  • Platelet count within past 12 months < 100,000. (Contraindication for deep tissue MT.)
  • INR International Normalized Ratio (INR) - (blood test used to monitor the effectiveness of blood thinning drugs) within past 12 months > 1.5 (Delayed clotting time is a contraindication for deep tissue MT.)
  • History of hepatosplenomegaly as deep tissue massage is contraindicated.
  • History of lung and/or liver transplant as deep tissue MT may be contraindicated with anti-rejection drug protocol.
  • Received MT within the past 30 days to eliminate the potential bias of previous response to treatment.
  • Skin condition or injury that would be contraindicated for MT and would restrict ability to apply massage strokes according to protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729585

Contacts
Contact: Kathleen Z Hass, MSN 513-636-7507 kate.zinkhass@cchmc.org
Contact: Lois Bogenschutz, BSN 513-803-0788 lois.bogenschutz@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Kathleen Z Hass, MSN    513-636-7507    kate.zinkhass@cchmc.org   
Contact: Lois Bogenschutz, BSN    513-803-0788    lois.bogenschutz@cchmc.org   
Principal Investigator: Kathleen Z Hass, MSN         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Kathleen Z Hass, MSN Cincinnati Children's Hospital, Division of Child Life and Integrative Care
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01729585     History of Changes
Other Study ID Numbers: IRB#2009-0918
Study First Received: November 15, 2012
Last Updated: July 26, 2013
Health Authority: Unites States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:
cystic fibrosis
quality of life

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014