Anodyne Therapy: A Photo-Energy Treatment Modality

Research

Anodyne is the only infrared light therapy device with 15 studies involving over 5000 patients published in peer-reviewed journals documenting efficacy, including design, wavelength, photo-energy output and patented photo energy flexible array application process

The following data and/or pictures show the evidence of increased circulation or reduced pain in various situations and are not meant to represent efficacy on any particular condition.

Circulation Improvement Studies

Moor Scanning Laser Doppler imaging studies objectively record circulatory improvement following a 20-30 minute Anodyne treatment on various patients at the indicated treatment site. The darker the blue, the less circulation in the area.

Feet - patient with poor lower extremity circulation. Pre- and post-treatment images show a 400% increase in circulation following an Anodyne treatment. Comparison is made to thermal therapy alone, which produced circulatory improvement of only 40%. This demonstrates the thermal effect alone cannot account for the increased micro-circulation - the effects of Anodyne involve much more than the simple application of heat.

Heel - Heels have notoriously poor circulation. Pre- and post-treatment images show a 3200% increase in circulation following a 20-minute Anodyne treatment. Many nursing facilities use Anodyne to improve circulation in "mushy" heels that are starting to break down in patients who are bedridden.

Medial Knee over MCL - Pre- and post-treatment images show a 2000% increase in circulation following a 20-minute Anodyne treatment. This is compared to imaging post-ultrasound treatment (5cm head, 3 MHz frequency, 0.8 w/cm2 continuous x 6 min to an area) which showed no increase in micro-circulation. It is believed that ultrasound works deeper in the tissues and has no effect on micro-circulation at the surface.

Sacral spine - Pre- and post-treatment images show a 1300% increase in circulation following a 20-minute Anodyne treatment.

Elbow - Pre- and post-treatment images show a 1300% increase in circulation following an Anodyne treatment.

Venous Stasis Ulcer-Circulation Studies
These ulcers are common in people who have poor veins/circulation. The involved skin is notorious for constantly breaking open again and again. Typically these wounds do not heal well, or with good strength due to poor circulation in the area.

While Anodyne therapy is not cleared by FDA for wound healing, Anodyne therapy is cleared for increasing local circulation and reducing pain.

Based on observations that:

• without proper circulation, many wounds will not heal because the oxygen and nutrients necessary for cell growth are not present, and
• many wounds are very painful,

it would be reasonable in many cases to consider Anodyne therapy in an attempt to improve local circulatory activity and decrease pain in conditions such as venous stasis ulcers.

Venous stasis ulcer - Patient with a 40-year history of venous stasis ulcers. Four-year-old ulcer treated with Anodyne to improve circulation. Ulcer fully healed. Follow up scan 3 years after final Anodyne treatment still showing three-fold improved circulation in the treated area compared to an untreated area.

Venous stasis ulcer/PVD - 79-year-old patient with a history of PVD for 40 years. The ulcer had been present for 40 years because there was such poor circulation at the surface of the tissue. Ulcer treated with Anodyne to improve circulation. Within 5 months, normal circulation had returned, ulcer completely healed with good tensile strength. No skin breakdown during the 4-year follow up period, no scarring at all in treated area.

[Note: Anodyne is not cleared for venous stasis ulcer wound healing. These reports are only meant to show the increase in circulation produced by Anodyne therapy and not meant to infer that Anodyne therapy alone heals wounds.]

Extremely Painful Post-Op Total Knee Replacement Complication - Pain, Loss of Range of Motion
Patient at 2 months post Total Knee Replacement. Surgical site so painful patient unable to move knee at all. Wound inflamed, necrotic tissue present. The surgeon wanted to perform additional surgery to clean out wound. The patient did not want additional surgery. The physical therapist asked the surgeon for 30 days to try Anodyne therapy. Within 36 days, using Anodyne, the site almost fully healed. The patient was able to start moving knee following first treatment. No further surgery needed.

[Note: Anodyne is not cleared for wound healing or improving range of motion. This report is only meant to show the increase in circulation and reduction of pain produced by Anodyne therapy and not meant to infer that Anodyne therapy alone heals wounds.]

Painful Scleroderma Ulcer, Raynauds Vasculopathy, Tenosynovitis, Sjogren's Syndrome

The patient had previous amputations of one full finger, remaining fingertips due to vascular compromise and subsequent necrosis. Taking 25 mg methadone daily for ischemic pain, Vicodin for breakthrough pain. In the previous 6 months, the patient had 19 physician visits, multiple medications, several surgeries in an attempt to improve circulation - all without improvement. Could not write, button clothing, open jars, or do needlework.

Started Anodyne therapy, 3 times weekly, 25 minutes per treatment in combination with Occupational therapy. After 2 weeks, pain significantly reduced, range of motion improved. After 7 weeks of therapy, off all pain medications/narcotics, able to button clothing, write, do needlework. Patient discharged with Anodyne home system for the continuation of maintenance therapy.

[Note: Anodyne is not cleared for wound healing, scleroderma, Raynaud's or improved range of motion. This report is only meant to show the increase in circulation and reduction of pain produced by Anodyne therapy and not meant to infer that Anodyne therapy alone heals wounds.]

Painful Ischemia
A 54-year-old patient with severe Peripheral Vascular Disease. Had right foot amputated 6/2000 due to ischemia. Took 9 months to heal due to poor circulation. Severe left foot ischemic pain began 2/2001. Unresponsive to the stent, 60 hyperbaric oxygen treatments. Pain unresponsive to lidocaine patches, Elavil nightly, and ~ 8 Vicodin daily. Left toes started turning black 8/2001. Anodyne started mid-August with 60 minute daily treatments.

After 2 weeks Anodyne, patient decreased Vicodin from 8 daily down to one daily. After 4 weeks, black dead tissue began loosening. By 20 weeks, complete healing of toes 2-5, significant pain relief continued.

[Note: Anodyne is not cleared for wound healing. This report is only meant to show the increase in circulation and reduction of pain produced by Anodyne therapy and not meant to infer that Anodyne therapy alone heals wounds.]

Painful Ischemia, Ulcer in Diabetic
A 61-year-old poorly controlled diabetic, with rheumatoid arthritis on prednisone, anemia, poor nutrition. Injury began as a scratch in Feb 2003. Developed severe ischemia due to complete occlusion of the posterior tibial artery. Extreme pain - 8 Vicodin per day. Massive deep ulcer. Failed treatments: angioplasty, 25 hyperbaric oxygen treatments, 4 weeks of wound V.A.C. negative pressure suction. By 6/11/2004, ulcer worsening with Achilles tendon and lateral tendon exposed, so treatment discontinued. The patient was informed he would need below the knee amputation. Anodyne started 7/8/2004 by home health agency for pain control.

• 8/25/2004 - After 7 weeks Anodyne, pain dramatically reduced, wound beginning to heal for the first time.
• 9/15/2004 - After 10 weeks Anodyne, tendons covered, Vicodin reduced from 8 daily to 1 at bedtime
• 12/29/2004 - After 20 weeks Anodyne, ulcer almost healed, little pain occurring.
• 1/29/2005 - At 24 weeks, treatment completed, patient discharged from home care - ulcer healed.

[Note: Anodyne is not cleared for wound healing. This report is only meant to show the increase in circulation and reduction of pain produced by Anodyne therapy and not meant to infer that Anodyne therapy alone heals wounds.]