Home Based Massage and Relaxation for Sickle Cell Pain

August 4, 2008 updated by: National Center for Complementary and Integrative Health (NCCIH)
The purpose of this study is to compare the effects of in-home, family-administered massage and in-home relaxation training on measures of physical status and health care utilization in a sample of African American adolescents age 15 years and older and adults with chronic pain associated with sickle cell disease who have been randomly assigned to six sessions of either family-administered massage or progressive muscle relaxation training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90007
        • Los Angeles Orthopaedic Hospital - Vascular Medicine Program
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Medically diagnosed with sickle cell disease, including hemoglobin SS disease, hemoglobin SD disease, hemoglobin SC disease, or sickle-thalassemia
  • Self-report of having experienced chronic pain related to sickle cell disease during the past 30 days.
  • Availability of a family member or friend who agrees to be trained to administer massages if the participant is randomized to the massage arm of the study.

Exclusion Criteria:

  • Sickle cell trait instead of sickle cell disease diagnosis.
  • Diagnosis of disease in addition to sickle cell disease which requires regular use of pain medication. (Please note, regular use of pain medication for sickle cell pain is NOT an exclusion)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Cynthia D. Myers, PhD, LMT, The Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

August 1, 2003

First Submitted That Met QC Criteria

August 4, 2003

First Posted (Estimate)

August 5, 2003

Study Record Updates

Last Update Posted (Estimate)

August 6, 2008

Last Update Submitted That Met QC Criteria

August 4, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT001078-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sickle Cell Disease

Clinical Trials on massage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe