Clinical trial NCT00688220: Effect of Celliant Materials on Pain and Blood Oxygenation in Subjects With Chronic Elbow and Wrist Pain
Official title: Effect of Celliant Materials on Pain and Blood Oxygenation in Subjects With Chronic Elbow and Wrist Pain
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Wrist Pain
Chronic Elbow Pain
Keywords: Arthritis
Carpel tunnel syndrome
Epicondylitis
Lead sponsor: Southern California Institute for Research and Education
Sponsor class: OTHER
Collaborators: name: Hologenix, LLC
First posted: 2008-06-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 4 weeks
measure: 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
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
Study officials:
affiliation: VA Long Beach Healthcare System
name: Ian Gordon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: