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

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Quality of Life; Cystic Fibrosis

Treatments: Procedure: Massage Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01729585

IRB#2009-0918

Details and patient eligibility

About

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).

Full 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?

Enrollment: 30 patients

Sex: All

Ages: 8 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

control group

No Intervention group

Description:

control group

Massage therapy

Active Comparator group

Description:

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.

Treatment:

Procedure: Massage Therapy