Clinical trial NCT01729585: The Effects of Massage Therapy on QOL in Youth/Young Adults With Cystic Fibrosis
Official title: The Effects of Massage Therapy on Quality of Life in Youth and Young Adults With Cystic Fibrosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Quality of Life
Keywords: cystic fibrosis
quality of life
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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?

Eligibility 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.) \* This criteria was eliminated to expand eligible subjects (including PFT baseline \>100).
* 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.) \* this criteria was omitted after study began as subjects were frequently being treated with antibiotics secondary to CF and pulmonary exacerbations.
* 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.) \*eliminated this criteria with medical approval.
* 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.) \* eliminated this criteria with medical approval.
* 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. \*changed protocol to allow enrollment and wait 30 days to initiate protocol.
* Skin condition or injury that would be contraindicated for MT and would restrict ability to apply massage strokes according to protocol

Primary outcomes:
measure: Quality of life _Peds QOL and CFQ-R
timeFrame: 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
Secondary outcomes:
measure: Pulmonary function
timeFrame: 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.
Other outcomes:
measure: Pain
timeFrame: 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
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Children's Hospital, Division of Child Life and Integrative Care
name: Kathleen A Zink, MSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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).