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Trial record 22 of 31 for:    CTPS1

Far Infrared Radiation for Sickle Cell Pain Management

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: NCT00599482
Recruitment Status : Unknown
Verified January 2009 by GAAD Medical Research Institute Inc..
Recruitment status was:  Active, not recruiting
First Posted : January 23, 2008
Last Update Posted : January 5, 2009
Sponsor:
Information provided by:
GAAD Medical Research Institute Inc.

Tracking Information
First Submitted Date  ICMJE January 11, 2008
First Posted Date  ICMJE January 23, 2008
Last Update Posted Date January 5, 2009
Study Start Date  ICMJE January 2008
Estimated Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2008)
Pain Management [ Time Frame: 40 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00599482 on ClinicalTrials.gov Archive Site
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 Far Infrared Radiation for Sickle Cell Pain Management
Official Title  ICMJE Phase 1 Study to Examine the Use of Far Infrared Radiation for Pain Management During Sickle Cell Crisis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Anemia, Sickle Cell
Intervention  ICMJE Radiation: Far Infrared Radiation (5μm to 20μm wavelength)
Far infrared radiation for 30 to 40 minutes during each session.
Study Arms  ICMJE 1
Far Infrared Radiation
Intervention: Radiation: Far Infrared Radiation (5μm to 20μm wavelength)
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 11, 2008)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2009
Estimated Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • People with sickle cell disease

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00599482
Other Study ID Numbers  ICMJE GAAD-SCC-CTP1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Kwasi Donyina/Founder and President, GAAD Medical Research Institute Inc.
Study Sponsor  ICMJE GAAD Medical Research Institute Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ken Nedd, M.D. GAAD Medical Research Institute Inc.
Study Director: Kwasi Donyina, Ph.D. GAAD Medical Research Institute Inc.
PRS Account GAAD Medical Research Institute Inc.
Verification Date January 2009

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