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Effect of Celliant Materials on Pain and Blood Oxygenation in Subjects With Chronic Elbow and Wrist Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00688220
Recruitment Status : Terminated (PI closed study due to lack of enrollment)
First Posted : June 2, 2008
Last Update Posted : June 4, 2010
Sponsor:
Collaborator:
Hologenix, LLC
Information provided by:
Southern California Institute for Research and Education

Study Description
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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.

Condition or disease
Chronic Wrist Pain Chronic Elbow Pain

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.
Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : July 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009
Groups and Cohorts
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Group/Cohort
1
Those wearing garments fabricated with Celliant
2
Those not wearing garments fabricated using Celliant (placebo).


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688220


Locations
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United States, California
VA Long Beach Healthcare System
Long Beach, California, United States, 90822-5201
Sponsors and Collaborators
Southern California Institute for Research and Education
Hologenix, LLC
Investigators
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Principal Investigator: Ian Gordon, M.D., Ph.D. VA Long Beach Healthcare System
More Information
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Responsible Party: Ian Gordon, M.D., Ph.D., VA Long Beach Healthcare System
ClinicalTrials.gov Identifier: NCT00688220    
Other Study ID Numbers: #887
First Posted: June 2, 2008    Key Record Dates
Last Update Posted: June 4, 2010
Last Verified: June 2010
Keywords provided by Southern California Institute for Research and Education:
Arthritis
Carpel tunnel syndrome
Epicondylitis