Back to resultsFar Infrared Radiation for Sickle Cell Pain Management
Primary Purpose
Anemia, Sickle Cell
Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Far Infrared Radiation (5μm to 20μm wavelength)
Sponsored by
About this trial
This is an interventional supportive care trial for Anemia, Sickle Cell focused on measuring HEMOGLOBIN SC DISEASE, HEMOGLOBIN C DISEASE, SICKLE CELL TRAIT, THALASSEMIA
Eligibility Criteria
Inclusion Criteria:
- People with sickle cell disease
Exclusion Criteria:
- None
Sites / Locations
- The Centre for Incurable Diseases
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Far Infrared Radiation
Outcomes
Primary Outcome Measures
Pain Management
Secondary Outcome Measures
Full Information
NCT ID
NCT00599482
First Posted
January 11, 2008
Last Updated
January 2, 2009
Sponsor
GAAD Medical Research Institute Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00599482
Brief Title
Far Infrared Radiation for Sickle Cell Pain Management
Official Title
Phase 1 Study to Examine the Use of Far Infrared Radiation for Pain Management During Sickle Cell Crisis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2008 (Anticipated)
Study Completion Date
January 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
GAAD Medical Research Institute Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Most patients with sickle-cell disease have periodic intensely painful episodes. To manage this pain, we are proposing the drinking of at least 500 mL of water followed by far infrared radiation.
Detailed Description
Painful sickle cell crises are treated with hydration and analgesics. Ischemia is an absolute or relative shortage of the blood supply to an organ. Relative shortage means the mismatch of blood supply (oxygen delivery) and blood request for adequate oxygenation of tissue.
It is hereby postulated that far infrared radiation of the body will promote blood and oxygen supply to the affected tissues. In addition, the analgesic properties of far infrared will alleviate pain due to the crisis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Sickle Cell
Keywords
HEMOGLOBIN SC DISEASE, HEMOGLOBIN C DISEASE, SICKLE CELL TRAIT, THALASSEMIA
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Far Infrared Radiation
Intervention Type
Radiation
Intervention Name(s)
Far Infrared Radiation (5μm to 20μm wavelength)
Intervention Description
Far infrared radiation for 30 to 40 minutes during each session.
Primary Outcome Measure Information:
Title
Pain Management
Time Frame
40 minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
People with sickle cell disease
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Nedd, M.D.
Organizational Affiliation
GAAD Medical Research Institute Inc.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kwasi Donyina, Ph.D.
Organizational Affiliation
GAAD Medical Research Institute Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The Centre for Incurable Diseases
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5R 3G9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Far Infrared Radiation for Sickle Cell Pain Management
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