Home Based Massage and Relaxation for Sickle Cell Pain

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00066079
First received: August 1, 2003
Last updated: August 4, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Sickle Cell Disease
Procedure: massage
Behavioral: relaxation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Home Based Massage and Relaxation for Sickle Cell Pain

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 30
Study Start Date: August 2003
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066079

Locations
United States, California
Los Angeles Orthopaedic Hospital - Vascular Medicine Program
Los Angeles, California, United States, 90007
United States, Florida
Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Investigators
Principal Investigator: Cynthia D. Myers, PhD, LMT The Moffitt Cancer Center
  More Information

Publications:
Bernstein DA, Borkovec TD. 1973. Progressive relaxation training: A manual for the helping professions. Champaign, Ill: Research Press. Field TM. Massage therapy effects. Am Psychol 1998, 53, 1270-1281.
Myers CD, Robinson ME, Guthrie TH, Jr, Lamp SP, Lottenberg R. Adjunctive approaches for sickle cell chronic pain. Alternative Health Practitioner 1999;5:203-212.36.

ClinicalTrials.gov Identifier: NCT00066079     History of Changes
Other Study ID Numbers: R21 AT001078-01A1
Study First Received: August 1, 2003
Last Updated: August 4, 2008
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Sickle Cell Pain
Sickle Cell Disease
Chronic Pain
Alternative Medicine/Therapy
Complementary Medicine
Massage Therapy
Relaxation Technique
Home-based Therapy

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies

ClinicalTrials.gov processed this record on October 29, 2014