Effect of Celliant Materials on Pain and Blood Oxygenation in Subjects With Chronic Elbow and Wrist Pain
The purpose of this research is to determine whether a new type of fabric, Celliant, can reduce elbow and wrist pain associated with chronic medical conditions such as carpel tunnel syndrome, arthritis or tennis elbow and whether it can increase blood flow and oxygenation levels in the arms and hands after wearing the material.
Chronic Wrist Pain
Chronic Elbow Pain
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Effect of Celliant Materials on Pain and Blood Oxygenation in Subjects With Chronic Elbow and Wrist Pain|
- Mean questionnaire scores for each question at Visits 1 and 2 will be compared to the mean scores from Visits 3 and 4 to assess change in symptoms in subjects with Celliant or placebo garments using Mann-Whitney t-test statistics. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Oxygenation levels of the elbow or wrist and hands at each time point will be compared between Celliant and placebo materials using standard statistical methods [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Those wearing garments fabricated with Celliant
Those not wearing garments fabricated using Celliant (placebo).
A new type of fabric, Celliant, is made from polymer yarns containing optically active particles (1-1.2 micron diameter titanium dioxide, quarts and aluminum oxide particles) with modify absorption, reflection and transmission of light in the visible and near infrared portion of the spectrum. It is believed that the Celliant particles increase skin illumination such taht cytochrome pigments and other enzymes are activated, leading to increased blood flow and oxygenation of the skin and neighboring soft tissues. In addition, numerous anecdotal reports from patients with chronic foot and arm pain indicate that wearing Celliant garments for even a few days leads to dramatic improvement in many different painful conditions. This is a single center, stratified, randomized, prospective, double-blind study. Questionnaires that subjects will be asked complete are 1) Visual Analog Scale, 2) Brief Pain Inventory, 3) McGill Short Form Pain Survey and 4) SF-36 Quality of Life Inventory.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688220
|United States, California|
|VA Long Beach Healthcare System|
|Long Beach, California, United States, 90822-5201|
|Principal Investigator:||Ian Gordon, M.D., Ph.D.||VA Long Beach Healthcare System|