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

This study has been terminated.
(PI closed study due to lack of enrollment)
Sponsor:
Collaborator:
Hologenix, LLC
Information provided by:
Southern California Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT00688220
First received: May 28, 2008
Last updated: June 2, 2010
Last verified: June 2010
  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

Further study details as provided by Southern California Institute for Research and Education:

Primary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688220

Locations
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
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 October 22, 2014