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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

Tracking Information
First Submitted Date May 28, 2008
First Posted Date June 2, 2008
Last Update Posted Date June 4, 2010
Study Start Date July 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2008)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Chronic Wrist Pain
  • Chronic Elbow Pain
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Those wearing garments fabricated with Celliant
  • 2
    Those not wearing garments fabricated using Celliant (placebo).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: June 2, 2010)
0
Original Estimated Enrollment
 (submitted: May 30, 2008)
80
Actual Study Completion Date December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00688220
Other Study ID Numbers #887
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ian Gordon, M.D., Ph.D., VA Long Beach Healthcare System
Study Sponsor Southern California Institute for Research and Education
Collaborators Hologenix, LLC
Investigators
Principal Investigator: Ian Gordon, M.D., Ph.D. VA Long Beach Healthcare System
PRS Account Southern California Institute for Research and Education
Verification Date June 2010