Effect of Celliant Materials on Pain and Blood Oxygenation in Subjects With Chronic Elbow and Wrist Pain
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Purpose
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.
| Condition |
|---|
|
Chronic Wrist Pain Chronic Elbow Pain |
| Study Type: | Observational |
| 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 ]
| Enrollment: | 0 |
| Study Start Date: | July 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Those wearing garments fabricated with Celliant
|
|
2
Those not wearing garments fabricated using Celliant (placebo).
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Participating subjects will be recruited who have chronic elbow or wrist pain from epidondylitis, carpal tunnel syndrom or other chronic disease - 40 with chronic elbow and 40 will chronic wrist pain.
Inclusion Criteria:
- Chronic pain for a minimum of 6 months
- A score of equal to or greater than 3 on question III of McGill Short Form Pain Questionnaire
Exclusion Criteria:
- Open wounds on the involved limb
- Threatened limb loss from ischemia
- Changes in pain or inflammatory medication within the last 30 days
- Psychiatric or other conditions that would affect compliance
- Inability to comply with use of the study articles or to fill out questionnaires
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Ian Gordon, M.D., Ph.D., VA Long Beach Healthcare System |
| ClinicalTrials.gov Identifier: | NCT00688220 History of Changes |
| Other Study ID Numbers: | #887 |
| Study First Received: | May 28, 2008 |
| Last Updated: | June 2, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Southern California Institute for Research and Education:
|
Arthritis Carpel tunnel syndrome Epicondylitis |
ClinicalTrials.gov processed this record on May 16, 2013