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Far Infrared Radiation for Sickle Cell Pain Management

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by GAAD Medical Research Institute Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
GAAD Medical Research Institute Inc.
ClinicalTrials.gov Identifier:
NCT00599482
First received: January 11, 2008
Last updated: January 2, 2009
Last verified: January 2009
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase 1 Study to Examine the Use of Far Infrared Radiation for Pain Management During Sickle Cell Crisis

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

Keywords provided by GAAD Medical Research Institute Inc.:
HEMOGLOBIN SC DISEASE
HEMOGLOBIN C DISEASE
SICKLE CELL TRAIT
THALASSEMIA

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 22, 2013