Energy Specific Far Infrared Radiation Treatment for Sciatica - Full Text View

Sponsored by:	GAAD Medical Research Institute Inc.
Information provided by:	GAAD Medical Research Institute Inc.
ClinicalTrials.gov Identifier:	NCT00573807

Purpose

A preliminary study to determine the use of far infrared radiation for the treatment of back pain

Condition	Intervention	Phase
Sciatica	Radiation: Far Infrared Radiation (5μm to 20μm wavelength)	Phase I

MedlinePlus related topics: Back Pain Sciatica

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Sciatica.

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

Primary Outcome Measures:

The primary end point is to determine the therapeutic effects of far infrared radiation on the Sciatic nerve. [ Time Frame: 2 years and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Far infrared treatment for other pain syndromes [ Time Frame: 2 years and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	2
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Radiation: Far Infrared Radiation (5μm to 20μm wavelength) Far Infrared Radiation (5μm to 20μm wavelength)for 30 to 40 minutes per treatment session.

Detailed Description:

Sciatica is created by joint misalignment, muscle spasm and inflammation. Generally, sciatica is a combination of lower back pain, pain radiating into the buttock and possibly down the leg.

Far infrared radiation of the sciatic nerve, coupled with the stretching of the spinal cord, is a promising non-invasive method for treating sciatica.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Persons with lower back pain

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573807

Locations

Canada, Ontario
The Centre for Incurable Diseases
Toronto, Ontario, Canada, M4V 1L5

Sponsors and Collaborators

GAAD Medical Research Institute Inc.

Investigators

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

More Information

Responsible Party:	GAAD Medical Research Institute Inc. ( Dr. Kwasi Donyina/Founder & President )
Study ID Numbers:	GAAD-SCIA-CTP1
Study First Received:	December 12, 2007
Last Updated:	January 2, 2009
ClinicalTrials.gov Identifier:	NCT00573807
Health Authority:	Canada: Health Canada

Keywords provided by GAAD Medical Research Institute Inc.:

Neuralgia, Sciatic
Sciatic Neuralgia
Sciatica, Bilateral
Lower back pain

Study placed in the following topic categories:

Sciatica
Signs and Symptoms
Neuromuscular Diseases
Neuralgia
Peripheral Nervous System Diseases

Neurologic Manifestations
Low Back Pain
Pain
Mononeuropathies
Back Pain

Additional relevant MeSH terms:

Sciatic Neuropathy
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009