Back to resultsEnergy Specific Far Infrared Radiation Treatment for Sciatica
Primary Purpose
Sciatica
Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Far Infrared Radiation (5μm to 20μm wavelength)
Sponsored by
About this trial
This is an interventional treatment trial for Sciatica focused on measuring Neuralgia, Sciatic, Sciatic Neuralgia, Sciatica, Bilateral, Lower back pain
Eligibility Criteria
Inclusion Criteria:
- Persons with lower back pain
Exclusion Criteria:
- None
Sites / Locations
- The Centre for Incurable Diseases
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
The primary end point is to determine the therapeutic effects of far infrared radiation on the Sciatic nerve.
Secondary Outcome Measures
Far infrared treatment for other pain syndromes
Full Information
NCT ID
NCT00573807
First Posted
December 12, 2007
Last Updated
January 2, 2009
Sponsor
GAAD Medical Research Institute Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00573807
Brief Title
Energy Specific Far Infrared Radiation Treatment for Sciatica
Official Title
Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Sciatica.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
GAAD Medical Research Institute Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A preliminary study to determine the use of far infrared radiation for the treatment of back pain
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica
Keywords
Neuralgia, Sciatic, Sciatic Neuralgia, Sciatica, Bilateral, Lower back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
Far Infrared Radiation (5μm to 20μm wavelength)
Intervention Description
Far Infrared Radiation (5μm to 20μm wavelength)for 30 to 40 minutes per treatment session.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Far infrared treatment for other pain syndromes
Time Frame
2 years and 6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persons with lower back pain
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Nedd, M.D.
Organizational Affiliation
GAAD Medical Research Institute Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kwasi Donyina, Ph.D.
Organizational Affiliation
GAAD Medical Research Institute Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
The Centre for Incurable Diseases
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4V 1L5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Energy Specific Far Infrared Radiation Treatment for Sciatica
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