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

NCT01729585 | Completed

• 1 other identifier: IRB#2009-0918
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Cystic Fibrosis; Quality of Life

Keywords

cystic fibrosis; quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Pulmonary function

  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 (1)

• Pain

  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

Study Arms (2)

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.

Procedure: Massage Therapy

Interventions

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.

Massage therapy

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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).

  BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Massage

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Kathleen A Zink, MSN

  Cincinnati Children's Hospital, Division of Child Life and Integrative Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 20, 2012
• Study Start: July 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

US (1)