Far Infrared Radiation for Sickle Cell Pain Management - Full Text View

Sponsored by:	GAAD Medical Research Institute Inc.
Information provided by:	GAAD Medical Research Institute Inc.
ClinicalTrials.gov Identifier:	NCT00599482

Purpose

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.

Condition	Intervention	Phase
Anemia, Sickle Cell	Radiation: Far Infrared Radiation (5μm to 20μm wavelength)	Phase I

Genetics Home Reference related topics: beta thalassemia sickle cell disease

MedlinePlus related topics: Anemia Sickle Cell Anemia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase 1 Study to Examine the Use of Far Infrared Radiation for Pain Management During Sickle Cell Crisis

Further study details as provided by GAAD Medical Research Institute Inc.:

Primary Outcome Measures:

Pain Management [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Far Infrared Radiation	Radiation: Far Infrared Radiation (5μm to 20μm wavelength) Far infrared radiation for 30 to 40 minutes during each session.

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

People with sickle cell disease

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599482

Locations

Canada, Ontario
The Centre for Incurable Diseases
Mississauga, Ontario, Canada, L5R 3G9

Sponsors and Collaborators

GAAD Medical Research Institute Inc.

Investigators

Study Chair:	Ken Nedd, M.D.	GAAD Medical Research Institute Inc.
Study Director:	Kwasi Donyina, Ph.D.	GAAD Medical Research Institute Inc.

More Information

Responsible Party:	GAAD Medical Research Institute Inc. ( Dr. Kwasi Donyina/Founder and President )
Study ID Numbers:	GAAD-SCC-CTP1
Study First Received:	January 11, 2008
Last Updated:	January 2, 2009
ClinicalTrials.gov Identifier:	NCT00599482
Health Authority:	Canada: Health Canada

Keywords provided by GAAD Medical Research Institute Inc.:

HEMOGLOBIN SC DISEASE
HEMOGLOBIN C DISEASE
SICKLE CELL TRAIT
THALASSEMIA

Study placed in the following topic categories:

Hemoglobin SC disease
Hematologic Diseases
Hemoglobin SC Disease
Anemia
Anemia, Hemolytic
Pain
Thalassemia

Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hemoglobinopathies
Sickle Cell Trait
Hemoglobinopathy
Anemia, Sickle Cell

ClinicalTrials.gov processed this record on January 14, 2009