Back to resultsHome Based Massage and Relaxation for Sickle Cell Pain
Primary Purpose
Sickle Cell Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
massage
relaxation
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring Sickle Cell Pain, Sickle Cell Disease, Chronic Pain, Alternative Medicine/Therapy, Complementary Medicine, Massage Therapy, Relaxation Technique, Home-based Therapy
Eligibility 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)
Sites / Locations
- Los Angeles Orthopaedic Hospital - Vascular Medicine Program
- Moffitt Cancer Center and Research Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00066079
First Posted
August 1, 2003
Last Updated
August 4, 2008
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00066079
Brief Title
Home Based Massage and Relaxation for Sickle Cell Pain
Official Title
Home Based Massage and Relaxation for Sickle Cell Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
Sickle Cell Pain, Sickle Cell Disease, Chronic Pain, Alternative Medicine/Therapy, Complementary Medicine, Massage Therapy, Relaxation Technique, Home-based Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
massage
Intervention Type
Behavioral
Intervention Name(s)
relaxation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia D. Myers, PhD, LMT
Organizational Affiliation
The Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles Orthopaedic Hospital - Vascular Medicine Program
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States
Facility Name
Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
7644237
Citation
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Results Reference
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PubMed Identifier
8866159
Citation
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. doi: 10.1097/00002508-199609000-00006.
Results Reference
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PubMed Identifier
492819
Citation
Zeltzer L, Dash J, Holland JP. Hypnotically induced pain control in sickle cell anemia. Pediatrics. 1979 Oct;64(4):533-6.
Results Reference
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PubMed Identifier
523174
Citation
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):181-185. doi: 10.1016/0304-3959(79)90009-5.
Results Reference
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PubMed Identifier
6399460
Citation
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. doi: 10.1007/BF01000558.
Results Reference
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PubMed Identifier
3663738
Citation
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. doi: 10.1007/BF01000078.
Results Reference
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PubMed Identifier
3138879
Citation
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Results Reference
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PubMed Identifier
8788535
Citation
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. doi: 10.1037//0278-6133.15.1.3.
Results Reference
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PubMed Identifier
10711591
Citation
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. doi: 10.1037//0278-6133.19.1.85.
Results Reference
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PubMed Identifier
9308268
Citation
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. doi: 10.1080/00207149708416141.
Results Reference
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Home Based Massage and Relaxation for Sickle Cell Pain
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