Far Infrared Radiation Treatment for Osteoarthritis | NCT00573352

Studies
Far Infrared Radiation Treatment for Osteoarthritis

NCT00573352

Sponsor

GAAD Medical Research Institute Inc.

Status

Unknown status

Last Update Posted

Jan 5, 2009Estimated

Enrollment

2Estimated

Phase

Phase 1

Conditions

Osteoarthritis

Interventions

Far Infrared

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

Sep 2006

Primary Completion Date

Feb 2008Actual

Completion Date

Dec 2008Estimated

First Submitted Date

Dec 12, 2007

First Submission Date that Met QC Criteria

Dec 12, 2007

First Posted Date

Dec 14, 2007Estimated

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

A study to evaluate the possibility of using far infrared radiation to manage pain due to osteoarthritis.

Detailed Description

Arthritis consists of more than 100 different conditions. These conditions range from relatively mild forms such as tendonitis and bursitis to crippling forms as rheumatoid arthritis. Pain syndromes include fibromyalgia and arthritis-related disorders as lupus erythematosus that involve every part of the body. There are forms of the disease, such as gout that almost nobody connects with arthritis. Osteoarthritis is the most common form of arthritis.

The objective for the study is to access the possibility of using far infrared radiation for pain management.

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

2Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Far infrared radiation	Radiation: Far Infrared

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Far Infrared	Radiation	Far Infrared Radiation (5μm to 20μm wavelength). Duration is 30 to 40 minutes per session	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary end point is to determine the therapeutic effects of far infrared radiation on osteoarthritis		2 years and 9 months

Secondary Outcomes

Measure	Description	Time Frame
The therapeutic effects of far infrared radiation on all forms of arthritis		2 years and 9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1 year old and above

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Centre for Incurable Diseases		Toronto	Ontario	M4V 1L5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided