Home Based Massage and Relaxation for Sickle Cell Pain

This study has been completed.

First Received: August 1, 2003 Last Updated: August 4, 2008 History of Changes

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00066079

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Home Based Massage and Relaxation for Sickle Cell Pain

Resource links provided by NLM:

Genetics Home Reference related topics: sickle cell disease

MedlinePlus related topics: Sickle Cell Anemia

U.S. FDA Resources

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

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

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Cynthia D. Myers, PhD, LMT

The Moffitt Cancer Center

More Information

Publications:

Shapiro BS, Dinges DF, Orne EC, Bauer N, Reilly LB, Whitehouse WG, Ohene-Frempong K, Orne MT. Home management of sickle cell-related pain in children and adolescents: natural history and impact on school attendance. Pain. 1995 Apr;61(1):139-44.

Elander J, Midence K. A review of evidence about factors affecting quality of pain management in sickle cell disease. Clin J Pain. 1996 Sep;12(3):180-93. Review.

Zeltzer L, Dash J, Holland JP. Hypnotically induced pain control in sickle cell anemia. Pediatrics. 1979 Oct;64(4):533-6.

Co LL, Schmitz TH, Havdala H, Reyes A, Westerman MP. Acupuncture: an evaluation in the painful crises of sickle cell anaemia. Pain. 1979 Oct;7(2):181-5.

Thomas JE, Koshy M, Patterson L, Dorn L, Thomas K. Management of pain in sickle cell disease using biofeedback therapy: a preliminary study. Biofeedback Self Regul. 1984 Dec;9(4):413-20.

Cozzi L, Tryon WW, Sedlacek K. The effectiveness of biofeedback-assisted relaxation in modifying sickle cell crises. Biofeedback Self Regul. 1987 Mar;12(1):51-61.

Wang WC, George SL, Wilimas JA. Transcutaneous electrical nerve stimulation treatment of sickle cell pain crises. Acta Haematol. 1988;80(2):99-102.

Gil KM, Wilson JJ, Edens JL, Webster DA, Abrams MA, Orringer E, Grant M, Clark WC, Janal MN. Effects of cognitive coping skills training on coping strategies and experimental pain sensitivity in African American adults with sickle cell disease. Health Psychol. 1996 Jan;15(1):3-10.

Gil KM, Carson JW, Sedway JA, Porter LS, Schaeffer JJ, Orringer E. Follow-up of coping skills training in adults with sickle cell disease: analysis of daily pain and coping practice diaries. Health Psychol. 2000 Jan;19(1):85-90.

Dinges DF, Whitehouse WG, Orne EC, Bloom PB, Carlin MM, Bauer NK, Gillen KA, Shapiro BS, Ohene-Frempong K, Dampier C, Orne MT. Self-hypnosis training as an adjunctive treatment in the management of pain associated with sickle cell disease. Int J Clin Exp Hypn. 1997 Oct;45(4):417-32.

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.

Study ID Numbers:	R21 AT001078-01A1
Study First Received:	August 1, 2003
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00066079 History of Changes
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

Study placed in the following topic categories:

Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Anemia

Sickle Cell Anemia
Anemia, Hemolytic
Pain
Hemoglobinopathy
Anemia, Sickle Cell

Additional relevant MeSH terms:

Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies

Anemia
Anemia, Hemolytic
Anemia, Sickle Cell

ClinicalTrials.gov processed this record on September 02, 2009