Far Infrared Radiation for Sickle Cell Pain Management | NCT00599482

Studies
Far Infrared Radiation for Sickle Cell Pain Management

NCT00599482

Sponsor

GAAD Medical Research Institute Inc.

Status

Unknown status

Last Update Posted

Jan 5, 2009Estimated

Enrollment

10Estimated

Phase

Phase 1

Conditions

Anemia, Sickle Cell

Interventions

Far Infrared Radiation (5μm to 20μm wavelength)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Sep 2008Estimated

Completion Date

Jan 2009Estimated

First Submitted Date

Jan 11, 2008

First Submission Date that Met QC Criteria

Jan 11, 2008

First Posted Date

Jan 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2009

Last Update Posted Date

Jan 5, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Far Infrared Radiation	Radiation: Far Infrared Radiation (5μm to 20μm wavelength)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Far Infrared Radiation (5μm to 20μm wavelength)	Radiation	Far infrared radiation for 30 to 40 minutes during each session.	1

Measure	Description	Time Frame
Pain Management		40 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

People with sickle cell disease

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Centre for Incurable Diseases		Mississauga	Ontario	L5R 3G9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell
D006450	Hemoglobin SC Disease
D006445	Hemoglobin C Disease
D012805	Sickle Cell Trait
D013789	Thalassemia

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided