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The Effect of Topical Theraflex® RX in the Treatment of Masseter Muscle and the Temporomandibular Joint Pain

Use of TheraFlex RX® - TMJ topical cream for the treatment of temporomandibular joint and muscle pain.

Lobo SL, Mehta N, Forgione AG, Melis M, Al-Badawi E, Ceneviz C, Zawawi KH. Craniofacial Pain Center, Tufts University School of Dental Medicine, One Kneeland Street, Box 1, Boston, MA 02111, USA. silvia.lobo_lobo@tufts.edu

Abstract

This randomized, double-blind study was designed to evaluate the effectiveness of the topical cream Theraflex-TMJ (NaBob/Rx, San Mateo, CA) in patients with masseter muscle pain and temporomandibular joint (TMJ) pain. Fifty-two subjects (5 males and 47 females) were instructed to apply a cream over the afflicted masseter muscle(s) or over the jaw joint(s) twice daily for two weeks. Theraflex-TMJ cream was used by the experimental group, while a placebo cream was used by the control group. The means of pain ratings were calculated prior to the application of the cream (baseline), after ten days of tx (period 1), and 15 days of tx (period 2) days of treatment and five days after stopping the treatment (follow-up). There was a significant decrease in reported pain levels from baseline in the experimental group for period 1 (p < 0.01), period 2 (p < 0.001), and follow-up (p < 0.01). For the control group, no significant differences were found between the different time periods (p > 0.05). There was evidence of minor side effects such as skin irritation and/or burning on the site of the application in two subjects in the experimental as well as two subjects in the control groups. The data strongly suggest that Theraflex-TMJ topical cream is safe and effective for reducing pain in the masseter muscle and the temporomandibular joint.

PMID: 15134414 [PubMed - indexed for MEDLINE]


Theraflex vs. Commonly Used Analgesics
The TheraFlex RX® line represents a new approach to topical pain relief and soft tissue injury.  This is especially important today in light of increasing concerns regarding the safety of commonly used oral analgesic medications, especially the NSAIDs (non-steroidal anti-Inflammatory drugs).  Long term use of NSAIDs such as Aleve, Motrin, ibuprofen can be associated with serious gastrointestinal (GI) side effects including bleeding.  The newer COX-2 inhibitors such as Vioxx have been implicated in potentially life-threatening cardiovascular problems. Indeed both Vioxx and Bextra have been removed from the market for this reason.  Theraflex on the other hand represents a safe and effective pain treatment with minimal side effects.

Clinical Study of Theraflex
A randomized double-blind clinical study conducted by Tufts University School of Dental Medicine (Boston, MA) on patients with masseter muscle and temporomandibular joint (TMJ) pain validated the effectiveness of the Theraflex approach. The study  published in Cranio: The Journal of Craniomandibular Practice, Vol.22, no.2, April 2004 showed that Theraflex TMJ safely and effectively reduced pain in the masseter muscles and TMJ joint in difficult to treat TMJ patients.  After 2 (two) weeks, participants using Theraflex TMJ experienced a 68% (sixty-eight percent) reduction in masseter muscle pain, and a 50% (fifty percent) reduction in temporomandibular joint pain.  Importantly, five days after the last application of Theraflex, significant pain relief persisted.  This pain relief was achieved without side effects as are so frequently encountered with oral medications such as Advil, Vioxx, Celebrex, etc

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How TheraFlex RX® Works

By targeting the body’s natural anti-inflammatory systems, TheraFlex RX® produces symptomatic relief, limits the degree of injury and promotes tissue healing. 

Additionally therapeutic levels of trace element-amino acid complexes, herbal extracts, specialized  amino acid dipeptides, and MSM address other components of injury and aid in the relief of pain, inflammation and stiffness. Specifically the trace element-amino acid complexes in Theraflex activate the key anti-inflammatory enzyme, superoxide dismutase (SOD).

The several forms of SOD control the inflammatory response and limit tissue injury by scavenging and inactivating highly reactive, destructive free radicals such as superoxide and hydroxyl.  Further these complexes enhance tissue healing by activating enzymes such as lysyl oxidase (LO), which plays a key role in cross-linking and stabilizing collagen and elastin, essential components of connective tissue, and DNA polymerase essential in making new DNA for replicating cells and healing tissue.

 Theraflex’s unique formulation ensures effective transdermal delivery of ingredients deep to the affected tissues and joints. The active ingredient common to the entire Theraflex line is methyl salicylate (wintergreen) which gives TheraFlex RX® its pleasant vanishing scent.  The base is water soluble, greaseless and a natural color.  All ingredients are FDA approved for OTC topical use.

How to Use TheraFlex RX®
Unlike other topical analgesics, smaller amounts (dime-sized) of Theraflex are all that are necessary to achieve optimal results.  Regular, daily usage, 2 to 4 times a day, maximizes the Theraflex benefit.  Used in such manner, for example, a 1.25 oz jar of Theraflex TMJ or RSI will last the average user at least one month. Further, washing the area 5- 10 minutes after application will not reduce its effectiveness.