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Home Based Massage and Relaxation for Sickle Cell Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00066079
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : August 6, 2008
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Tracking Information
First Submitted Date  ICMJE August 1, 2003
First Posted Date  ICMJE August 5, 2003
Last Update Posted Date August 6, 2008
Study Start Date  ICMJE August 2003
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home Based Massage and Relaxation for Sickle Cell Pain
Official Title  ICMJE Home Based Massage and Relaxation for Sickle Cell Pain
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE
  • Procedure: massage
  • Behavioral: relaxation
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00066079
Other Study ID Numbers  ICMJE R21AT001078-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cynthia D. Myers, PhD, LMT The Moffitt Cancer Center
PRS Account National Center for Complementary and Integrative Health (NCCIH)
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP