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University Research Studies on Pain, Swelling, Stiffness, Muscle Relaxation, and Improvement of Athletic Performance

These products have not been pre-cleared by FDA although applications have been prepared and will be reviewed shortly based on promising scientific research. Only FDA can conclude that a medical device is safe and effective for an intended use.


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Brigham Young University, University of Texas and Texas Tech


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Muscle Relaxation Study

Anti-Inflammatory Study

Pain Study

Osteoarthritis Pain Study


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Muscle Relaxation Study

Muscle relaxation study by a large Southwest University

Summary:

Once these standards were developed, the same procedures were followed only a massage cone was applied to the belly of the muscles. The results show that massage cone quickly allows the muscle to move to full flexibility.

Another study underway is 50% complete as to the field work. It involves muscle relaxation. The protocol was to test if our product induces muscle relaxation by interfering with the sensitivity of muscle stretch receptors. This study uses the massage cones.

Notes from the Researchers

The research has proven to be more difficult than anticipated primarily because there has never been any research, at least documented, concerning how muscles relax or why muscles become more flexible.

The research was performed on mice. Basically they measured the flexibility that would occur over a 20 minute period by moving the mouse leg back and forth during this time period. Numerous tests were performed at three different frequencies to establish the control. The charts show how the muscle resistance decreases over time. In other words, warming up your muscles moves them to maximum flexibility.

Once these standards were developed, the same procedures were followed only a massage cone was applied to the belly of the muscles. The results show that our product quickly allows the muscle to move to full flexibility.

In another test, the muscles were at full flexibility and then our product was applied. In these tests nothing happened.

The next stage of the study will be 1) To record nervous activity in dorsal roots of the spinal cord during static and dynamic stretch, and 2) To determine static and dynamic muscle stiffness with or without topical application following cutting of dorsal roots.

We have no idea how, or if, this muscle relaxation relates to the pain relieve or the anti-inflammatory action noted in the other studies. However, it is possible injury could be prevented if muscles were relaxed by wearing our product.

 

Pain Study

Excerpts from Pain Study being prepared for publication by a large Western University

Summary:

Two hours - control group subjects continued to feel worse or the same. 56% of treatment group felt significant improvement. Significance is .003.

24 hours - 25% of control had some improvement. 63% of treatment group had significant   improvement.

Three days - 30% of control group had slight improvement. 88% of treatment group had moderate to great improvement.

Seven days - 33% of control group subjects had again slight improvement. 91% of treatment group subjects had great to total improvement. Significance is .004.


METHODOLOGY
A group of 32 injury victims were selected from two locations. One a pain clinic where the injuries ranged from sports trauma to falls, and two "old injuries acting up." The other location was an athletic training center at a large Western University during basketball, volleyball, and track seasons. The injuries involved were strains, sprains, and trauma from falls, etc. There were no broken bones or deep cuts.

The subjects were randomly assigned to two groups, red or blue. All subjects were required to sign a consent form in order to join the study, however, neither the subject nor the trainer/nurse/physician knew whether red or blue was experimental or control. Each subject was asked—and agreed—not to ingest any type of analgesic or other pain medication nor obtain any other methods of treatment for their injury while participating in this study.
Results - the perceived levels of pain were calculated by subtracting the perceived level at each reporting time from the original perception:

� Thirty minutes - all control group subjects felt worse or no change. 31% of the treatment groups felt somewhat better. Significance of .024.

� Two hours - control group subjects continued to feel worse or the same. 56% of treatment group felt significant improvement. Significance is .003.

� 24 hours - 25% of control had some improvement. 63% of treatment group had significant improvement.

� Three days - 30% of control group had slight improvement. 88% of treatment group had moderate to great improvement.

� Seven days - 33% of control group subjects had again slight improvement. 91% of treatment group subjects had great to total improvement. Significance is .004.

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Anti-Inflammatory Study

Anti-inflammatory study by a large Southwest University

Summary:
These data indicate that semiconductors are an active topical anti-inflammatory agent when impregnated on cloth or tape.

The researchers studied the anti-inflammatory action of the semiconductors on mice ears. The test was made with croton oil solution. In one test, the comparatives were no treatment, hydrocortisone, plain ink, ink with 375, 400 and 500 jg/ear. The other test used the tape pads.

Results:

Semiconductors when formulated as ink has anti-inflammatory activity. Approximately 500 jg/ear and 400 jg/ear of semiconductors has comparable anti-inflammatory activity to 200 jg of hydrocortisone. Approximately 375 jg/ear of semiconductors had very little activity at 6 hrs., indicating that the concentration of semiconductors is very critical and a small decrease in concentration can result in a change from high anti-inflammatory activity to almost not anti-inflammatory activity.

The same test was made using our semiconductors impregnated tape pads. The results were the same.

Summary:
These data indicate that semiconductors are an active topical anti-inflammatory agent when impregnated on cloth or tape.

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Osteoarthritis Pain Studyarthritis, osteoarthritis, gout, stiff joints, joint pain, bursitis, aches, stiffness, stiff joints

Texas Tech and University of Texas, Graduate School for Nursing

Susan Pollock, Ph.D., RN, FAAH,    Principal Investigator

Deborah Osbourn, BSN, RN, LMT, FNPC   Investigator

November 1998

Summary:

T-test analyses of data demonstrated a moderate decrease in pain after two hours for both the study and placebo groups and a significant decrease in pain in only the study group after two days of treatment, supporting the hypothesis of a significant decrease in reported pain of subjects receiving treatment of topically applied Goode Wraps HexTape as compared to subjects receiving placebo therapy.

Osteoarthritis, a chronic degenerative joint disease affecting an estimated 16 million Americans, produces symptoms of joint pain and stiffness. Symptom abatement by traditional therapies is often ineffective and/or harmful to OA patients. These patients seek alternative therapies which are safe, effective, and provide a measure of self-care.

STUDY ABSTRACT

A double-blind, placebo quasi-experimental design was used to study the effects of topically applied Goode Wraps HexTapes adhesive tapes on osteoarthritis pain of 47 adult subjects. Self-administration of the Short Form McGill Pain Questionnaire was used to measure pain prior to treatment, two hours after treatment, and two days after initiation of treatment. Orem’s Theory of Self-Care was the theoretical basis for this study.

T-test analyses of data demonstrated a moderate decrease in pain after two hours for both the HexTapes and placebo groups and a significant decrease in pain in only the HexTape group after two days of treatment, supporting the hypothesis of a significant decrease in reported pain of subjects receiving treatment of topically applied Goode Wraps tapes as compared to subjects receiving placebo therapy.

Implications for nursing practice, education , and research were included. Informed integration of alternative therapies, as well as mainstream therapies, is appropriate within the holistic-focused care and educative role of the NP and in the self-care role of the client in management of chronic disorders. Inclusion of alternative therapies in nursing education at the undergraduate and graduate/NP levels is recommended. This is consistent with recommendations by the National Organization of Nurse Practitioner Faculties and the Office of Alternative Medicine at the NIH. Further research is recommended with different populations, other sites of application, and to determine HexTapes’s mechanism of action.

__________________               


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