NCT00573807

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 5, 2009

Status Verified

January 1, 2009

Enrollment Period

2.2 years

First QC Date

December 12, 2007

Last Update Submit

January 2, 2009

Conditions

Sciatica

Keywords

Neuralgia, SciaticSciatic NeuralgiaSciatica, BilateralLower back pain

Outcome Measures

Primary Outcomes (1)

  • The primary end point is to determine the therapeutic effects of far infrared radiation on the Sciatic nerve.

    2 years and 6 months

Secondary Outcomes (1)

  • Far infrared treatment for other pain syndromes

    2 years and 6 months

Study Arms (1)

1

OTHER
Radiation: Far Infrared Radiation (5μm to 20μm wavelength)

Interventions

Far Infrared Radiation (5μm to 20μm wavelength)RADIATION

Far Infrared Radiation (5μm to 20μm wavelength)for 30 to 40 minutes per treatment session.

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Persons with lower back pain

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Centre for Incurable Diseases

Toronto, Ontario, M4V 1L5, Canada

Location

MeSH Terms

Conditions

SciaticaLow Back Pain

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Study Officials

  • Ken Nedd, M.D.

    GAAD Medical Research Institute Inc.

    STUDY DIRECTOR

  • Kwasi Donyina, Ph.D.

    GAAD Medical Research Institute Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 14, 2007

Study Start

January 1, 2006

Primary Completion

March 1, 2008

Study Completion

December 1, 2008

Last Updated

January 5, 2009

Record last verified: 2009-01

Locations

CA(1)