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

Primary Purpose

Cystic Fibrosis, Quality of Life

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Massage Therapy

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis, quality of life

Eligibility Criteria

8 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control group

Massage therapy

Arm Description

control group

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pulmonary function

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.

Full Information

NCT ID

NCT01729585

First Posted

November 15, 2012

Last Updated

September 25, 2015

Sponsor

Children's Hospital Medical Center, Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT01729585

Brief Title

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

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee

5. Study Description

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: 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Quality of Life

Keywords

cystic fibrosis, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

No Intervention

Arm Description

control group

Arm Title

Massage therapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Massage Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Quality of life _Peds QOL and CFQ-R

Description

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

Secondary Outcome Measure Information:

Title

Pulmonary function

Description

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.

Other Pre-specified Outcome Measures:

Title

Pain

Description

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?"

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen A Zink, MSN

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

12. IPD Sharing Statement

Citations:

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).

Results Reference

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

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