Anodyne therapy

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Anodyne therapy

Postby tennesseegal » Fri Jan 12, 2007 8:50 pm

Hello everyone. My husband has severe leg lymphedema. We have been doing MLD and bandaging without great results. Seems like everytime we make progress, cellulitis develops. I was wondering if anyone has any experience with Anodyne therapy. I was told this was an option. Thanks.
tennesseegal
 
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Anodyne therapy for Lymphedema

Postby patoco » Fri Jan 12, 2007 9:18 pm

Hey Tennessee

Super welcome to our family here.

Anodyne therapy is controversial at best. Many medical facilities actually use it, while the insurance companies (Cigna, Aetna etc) all reject it as experimental and nonproven.

Anodyne therapy has been suggested for problems in blood circulatory problems, diabetic neuropathy, wounds, lymphedema and is used as a heat modality in certain physical therapies.

For lymphedema it is considered highly experimental and it's efficacy has yet to be proven. Infact, for all conditions on of the chief complaints is that it remains investigational for all conditions, due to the lack of well-controlled, randomized, double-blind trials.

Here is Cigna's position:

Anodyne ® Therapy System (ATS), also known as monochromatic near-infrared photo energy (MIRE), (Anodyne Therapy LLC, Tampa, FL) received approval by the U.S. Food and Drug Administration (FDA) in 1994 through the premarket 510(k) process. This device delivers monochromatic, near-infrared photo energy through contact with the skin. The light is emitted by an array of 60 superluminous gallium aluminum diodes located on a flexible pad. The company proposes that phototherapy exposure effects guanylate cyclase (GC) and nitrous oxide (NO) release, which stimulates vasodilation and relaxes smooth muscle cells in blood vessels. According to company literature, the "intense illumination of the skin may non-invasively increase the localized release of NO from hemoglobin” (Burke, 2005). The company states that this results in “better blood flow via stimulation of GC, acute delivery of growth factors and white blood cells, fibroblastic differentiation and proliferation, angiogenesis, reduced edema, and mediation of pain” (Burke, 2005). According to the manufacturer, ATS is a non-invasive, drug-free way to increase local circulation to nerves and tissues and reduce neuropathic pain.

ATS has been proposed as a treatment modality for several indications, including peripheral neuropathy, pain management and wound healing. There has been insufficient evidence, however, in the peerreviewed, evidence-based literature to support this claim.

ATS for the treatment of diabetic peripheral neuropathy (DPN) is not recognized as a standard of care by the American Association of Clinical Endocrinologists, the American Diabetes Association, the American Academy of Neurology, the American Medical Association, the American Orthopedic Foot and Ankle Society or the American Podiatric Medical Association.

Kochman et al. (2002) conducted a small case study of 49 consecutive subjects to test the effectiveness of ATS in patients with DPN, using sensation as an indicator measure. All participants had established DPN and were treated with ATS. A decrease in the loss of protective sensation (LOPS) as a consequence of diabetic neuropathy was the endpoint. Semmes-Weinstein monofilaments (SWMs) were used to measure hot and cold sensation. Values of 4.56 and higher were noted in all participants prior to treatment. Patients were stratified according to LOPS levels; seven patients (14%) had levels between 4.56 and 6.45, and the remaining 42 patients (76%) had levels of 5.07 and higher. Fifty-four percent of patients had no sensation, while 46% had impaired sensation. After six treatments, the SWM test was repeated, and 48 subjects (98%) exhibited some improved sensation. After 12 treatments, all had noted improved sensation. A further analysis revealed that patients with both type I and type II diabetes benefited from the treatment; however, after 12 weeks of treatment, none of the participants had values higher than 4.93. Although these results suggest that monochromatic phototherapy may provide improved pressure and heat sensitivity in patients with DPN, the absence of a control group prevents deriving a definitive conclusion from this study. Additional studies are needed to determine the long-term effect of this therapy.

Carnegie et al. (2001) conducted a double-blind, placebo-controlled study of eight patients (16 limbs) with LOPS. Each lower limb on each patient received a single, 45-minute ATS treatment with four therapy pads. In addition, one limb was treated with functional diode arrays, while the opposite limb was treated with inactivated (placebo) arrays. All actively treated limbs achieved protective sensation, as demonstrated by an increased number of sensation sites, compared to the placebo group. The study did not include measuring the duration of the improved sensation. The study was limited by the small sample size and by a lack of both randomization sampling and double blinding. One of the authors of this study is employed by Anodyne Therapy LLC.

Goldman (2001) conducted a retrospective study of nine patients who received 12 ATS treatments with two therapy pads. Re-examination occurred at 12-24 weeks after the final ATS treatment was completed. All 18 limbs obtained improved sensation as measured by SWM; at follow-up, however, eight patients experienced a decline in sensation, and one patient maintained the sensory improvement obtained from the therapy. Goldman indicated that, to achieve long-term restoration of sensation, treatment would have to remain ongoing. These studies showed that improved sensation diminished as early as 12 weeks after the therapy ceased. No placebo was used for the study; the sample size was small; participants were not randomly selected; and the study was not double blinded.

Kochman (2004) studied 38 participants (mean age 78) with confirmed neuropathy who received comprehensive treatment programs of ATS and physical therapy. The study aimed to determine if the combined therapies could improve sensation and balance and also decrease gait deficiencies and fall risk. All participants had experienced at least one fall in the three months prior to treatment. Participants received daily 30- to 40-minute treatments with ATS, followed by physical therapy. Physical therapy interventions consisted of static and dynamic balance retraining, neuromuscular re-education, strength training, and stretching of the ankle plantar flexors and hip flexors. After completion of the combined treatments, all patients had improvement in foot sensation and reduced their fall risk, as measured on the Tinetti scale. The author concluded that a combined therapy program could improve foot sensation, balance and gait and thus reduce the incidence of falls. The study was limited by its small size, as well as by a lack of control group, randomization, blinding and long-term follow-up. The methodology did not allow analysis of gains either attributable to physical therapy alone or related to an increase in foot sensation resulting from ATS alone.

Leonard et al. (2004) conducted a double-blind,
randomized, placebo-controlled study of 27 participants with diabetes and peripheral neuropathy. The participants were stratified into two groups, based on their ability to sense SWM 6.65 at all tested sites (group 1: n=18) or inability to sense the SWM 6.65 (group 2: n=9). All subjects initially received treatment with both active and sham ATS therapy for 40 minutes, threetimes per week for two weeks. This was followed by six active treatments of the same duration administered to both limbs during the following two weeks. Group 1 subjects receiving active treatment reduced the number of insensitive sites to the SWM. No decrease was noted with the sham device. In group 2, there was no significant difference with active treatment following the six or 12 treatments. Pain was reported decreased in group 1 subjects but was not significantly reduced in group 2 subjects. Balance was reported as improved following both the sixth and twelfth treatments in group 1 subjects. Group 2 subjects reported improvement after six treatments in four of the nine patients; thereafter, no further change was noted. The authors concluded that, for diabetics with LOPS who have not progressed to profound sensory loss, there can be a temporary improvement in sensation with the use of ATS. The study size was small, and the design did not measure pain reduction or balance improvement in active compared to sham treatment of individual limbs. There was a lack of objective measurement for balance impairment, and follow-up was limited to evaluation after 12 treatments, with no analysis of long-term durability.

Powell et al. (2004) conducted a study of 68 participants with diabetic neuropathy and LOPS who had no current lower extremity ulcers. The participants received ATS treatment in a self-administered home program. Participants treated themselves with the device 30-40 minutes per day for two months. If improved sensation was noted, then additional treatment was provided for an additional 2-7 days per week. An 11-question post-treatment health status questionnaire was sent to the participants, who were asked about foot wounds, amputations, fall history, fear of falling, activities of daily living and increased foot sensitivity. One patient reported development of a foot wound after the treatment program, and one patient reported a burn sustained from using the ATS device after falling asleep. The authors report that improved foot sensitivity appears to be associated with a lower incidence (1.5%) of new diabetic foot ulcers as compared to the expected incidence (7.3%) in the Medicare population. The study was limited by its small size and lack of a control group. The outcomes were based on self-reported patient responses. The study was funded in part by Anodyne Therapy LLC, and one of the authors disclosed that he is an employee of Anodyne Therapy LLC.

DeLessis et al. (2005) reviewed the medical records of 1047 patients with peripheral neuropathy to determine whether treatment with ATS was associated with increased foot sensitivity. The authors reported that the number of insensitive sites based on the SWM was 7.9/10.0 before treatment and 2.3/10.0 after treatment, with 452 (43%) patients exhibiting insensitivity at all 10 sites prior to treatment. Among these patients, there was a mean decrease of 69% in sensory impairment after treatment. The number of treatments was not noted. The authors concluded that 56.1% of the patients obtained at least a temporary return of protective sensation. The study did not incorporate a control group, randomization or blinding of the participants, and there was no long-term follow-up to determine the efficacy of the treatment.

Hayes (2003) issued a technology assessment brief which indicated that there is insufficient evidence to conclude that the use of MIRE reduces the severity of diabetic neuropathy. Definitive patient selection criteria have not been established; however, MIRE should not be used to treat individuals who are pregnant or who have an active malignancy.

Summary: The use of Anodyne ® therapy (ATS) or monochromatic near-infrared photo energy (MIRE) remains investigational for all conditions, due to the lack of well-controlled, randomized, double-blind trials. In addition, the lack of evidence of long-term durability does not support the efficacy of Anodyne ® therapy at this time.

And this is from Aetna:

Policy

Aetna considers treatment with low-level infrared light (infrared therapy, Anodyne® Therapy System) experimental and investigational for the treatment of chronic non-healing wounds, diabetic peripheral neuropathy, or lymphedema because of a lack of adequate evidence in the peer-reviewed published medical literature regarding the effectiveness of infrared therapy for these indications.

Notes:

Infrared light treatment is considered medically necessary as a heat modality in physical therapy (see CPB 325 - Physical Therapy).

Infrared coagulation is considered medically necessary for members with grade I or grade II internal hemorrhoids that are painful or persistently bleeding. (See appendix for grading of internal hemorrhoids.)

Background

Low-level infrared therapy:

Low-level infrared therapy is a type of low-energy laser that uses light in the infrared spectrum. The Anodyne Therapy System is a type of low-level infrared therapy, developed by Integrated Systems Physiology Inc. of Aurora, CO, that has been promoted for augmenting wound healing, for reversing the symptoms of peripheral neuropathy in people with diabetes, and for treating lymphedema. The manufacturer states that the Anodyne Therapy System increases circulation and reduces pain by increasing the release of nitric oxide.

Several meta-analyses have examined the evidence supporting the use of low-level (cold) lasers, including low-level infrared lasers, for treatment of chronic non-healing wounds. See CPB 363 - Cold Laser Therapy. These meta-analyses are unanimous in concluding that there is insufficient evidence to support low-level laser in the treatment of chronic venous ulcers or other chronic non-healing wounds.

There is no evidence that infrared light therapy is any more effective than other heat modalities in the symptomatic relief of musculoskeletal pain. Glasgow (2001) reported on the results of a randomized controlled clinical trial of low-level infrared therapy in 24 subjects with experimentally induced muscle soreness, and found no significant differences between treatment and placebo groups.

There are no published studies of the effectiveness of low-level infrared therapy for treatment of diabetic peripheral neuropathy. The case series presented by the manufacturer of the Anodyne System on its web site have not been published in a peer-reviewed medical journal.

Finally, there is no evidence in the published peer-reviewed medical literature on the effectiveness of infrared therapy for the treatment of lymphedema. The Canadian Coordinating Office of Health Technology Assessment (2002) found that “[t]here is little high quality controlled clinical trial evidence for these therapies.”

In a randomized, placebo-controlled study, Leonard et al (2004) examined whether treatments with the Anodyne Therapy System (ATS) would decrease pain and/or improve sensation diminished due to diabetic peripheral neuropathy (DPN). Tests involved the use of the 5.07 and 6.65 Semmes Weinstein monofilament (SWM) and a modified Michigan Neuropathy Screening Instrument (MNSI). Twenty-seven patients, 9 of whom were insensitive to the 6.65 SWM and 18 who were sensitive to this filament but insensitive to the 5.07 SWM, were studied. Each lower extremity was treated for 2 weeks with sham or active ATS, and then both received active treatments for an additional 2 weeks. The group of 18 patients who could sense the 6.65 SWM but were insensitive to the 5.07 SWM at baseline obtained a significant decrease in the number of sites insensate after both 6 and 12 active treatments (p < 0.02 and 0.001). Sham treatments did not improve sensitivity to the SWM, but subsequent active treatments did (p < 0.002). The MNSI measures of neuropathic symptoms decreased significantly (from 4.7 to 3.1; p < 0.001). Pain reported on the 10-point visual analog scale decreased progressively from 4.2 at entry to 3.2 after 6 treatments and to 2.3 after 12 treatments (both p < 0.03). At entry, 90 % of subjects reported substantial balance impairment; after treatment, this decreased to 17 %. However, among the group of 9 patients with greater sensory impairment measured by insensitivity to the 6.65 SWM at baseline, improvements in sensation, neuropathic symptoms, and pain reduction were not significant. The authors concluded that ATS treatments improved sensation in the feet of subjects with DPN, improved balance, and reduced pain.

There are a few drawbacks in this study. They include the small size of the study, and that it involved a single investigator group, arguing for the need to replicate this study. There is also no information about whether the improvements were durable. Furthermore, although the results are encouraging, more discreet quantitative sensory tests would be helpful in determining the exact degree of sensory improvement experienced after the administration of ATS treatments.

Infrared Coagulation for the Treatment of Hemorrhoids:

Infrared coagulation is one of the several non-surgical outpatient therapies in treating hemorrhoids. Linares et al (2001) examined the effectiveness of rubber band ligation (RBL) and infrared photocoagulation (IRC) in treating internal hemorrhoids in 358 patients with a total of 817 hemorrhoid. There was a follow-up period of 36 months. Two hundred ninety five of 358 patients were treated with RBL (82.4 %), this treatment being effective in 98 % of the patients after 180 days and very good after 36 months. There were 6/295 relapses at 36 months (2 %). All minor and major complications were observed within the first 15 days of treatment: rectal tenesmus in 96/295 patients (32.5 %), mild anal pain in 115/295 (38.9 %), self-limited and mild bleeding after the detachment of the bands in 30/295 (10 %), and febricula in one patient. Sixty three of 358 patients were treated with IRC (17.6 %). In this group, relapses were observed in 6/63 patients (9.5 %) at 36 months, all of them with grade III hemorrhoids that required additional treatment with RBL. All the complications (inherent to the technique) were observed within the first days: mild anal pain in 40/63 patients (63.4 %) and mild bleeding in 1/63 (1.6 %). The treatment with RBL or IRC depended on the number of hemorrhoids and the hemorrhoidal grade. No significant differences were found regarding the effectiveness between RBL and IRC for the treatment of grade I-II hemorrhoids, while RBL was more effective for grade III and IV hemorrhoids (p < 0.05). The authors concluded that RBL and IRC should be considered as a good treatment for all grades of hemorrhoids, due to its effectiveness, its cost-benefit and its small short and long-term morbidity.

In a randomized study, Gupta (2003) compared infrared coagulation and rubber band ligation in treating patients with early stages of hemorrhoids. One hundred patients with second degree bleeding piles were randomized prospectively to either rubber band ligation (n = 54) or infrared coagulation (n = 46). Parameters measured included post-operative discomfort and pain, time to return to work, relief in incidence of bleeding, and recurrence rate. Post-operative pain during the first week was more intense in the band ligation group (2 - 5 versus 0 - 3 on a visual analogue scale). Post-defecation pain was more intense with band ligation and so was rectal tenesmus (p = 0.0059). The patients in the infrared coagulation group resumed their duties earlier (2 versus 4 days, p = 0.03), but also had a higher recurrence or failure rate (p = 0.03). The authors concluded that band ligation, although more effective in controlling symptoms and obliterating hemorrhoids, is associated with more pain and discomfort to the patient. As infrared coagulation can be conveniently repeated in case of recurrence, it could be considered to be a suitable alternative office procedure for the treatment of early stage hemorrhoids.

The American Gastroenterological Association's technical review on the diagnosis and treatment of hemorrhoids (Madoff and Fleshman, 2004) stated that 1st degree and 2nd degree hemorrhoids (i.e., Grade I and Grade II hemorrhoids) can be treated with non-operative therapies such as infrared photocoagulation. Surgery is generally reserved for individuals who have large 3rd degree or 4th degree hemorrhoids, acutely incarcerated and thrombosed hemorrhoids, hemorrhoids with an extensive and symptomatic external component, or individuals who have undergone less aggressive therapy with poor results.

The above policy is based on the following references:

Anodyne Therapy, LLC. Anodyne Therapy. Tampa, FL:Anodyne; 2004. Available at: http://www.anodynetherapy.com/. Accessed September 15, 2004.
Horwitz LR, Burke TJ, Carnegie D. Augmentation of wound healing using monochromatic energy. Adv Wound Care. 1999;12(1):35-40. Available at: http://www.fasterhealing.com/reports/wndpapr.pdf. Accessed January 15, 2002.
Glasgow PD, Hill ID, McKevitt AM, et al. Low intensity monochromatic infrared therapy: A preliminary study of the effects of a novel treatment unit upon experimental muscle soreness. Lasers Surg Med. 2001;28(1):33-39.
Thomasson TL. Effects of skin-contact monochromatic infrared irradiation on tendonitis, capsulitis, and myofascial pain. J Neurol Orthop Med Surg. 1996;16:242-245. Available at: http://www.fasterhealing.com/reports/TomPapr.pdf. Accessed January 15, 2002.
Kocham AB, Carnegie D, Burke TJ. Symptomatic reversal of peripheral neuropathy in diabetic patients. Aurora, CO: Integrated Systems Physiology, Inc.; 2001. Available at: http://www.fasterhealing.com/reports/neuropathy.pdf. Accessed January 15, 2002.
Galeano M. Lymphedema case study. Tampa, FL: MedAssist Group; 2001. Available at: http://www.fasterhealing.com/reports/lymphedema.pdf. Accessed January 15, 2002.
Anodyne Therapy, LLC. Anodyne testimonials. Tampa, FL: Fasterhealing.com; 1998. Available at: http://www.fasterhealing.com/references.htm. Accessed January 15, 2002.
Flemming K, Cullum N. Laser therapy for venous leg ulcers. Cochrane Review. In: The Cochrane Library, Issue 4, 2001. Oxford, UK: Update Software; 2001.
Beckerman H, de Ble R, Bouter L, et al. The efficacy of laser therapy for musculoskeletal and skin disorders: A criteria-based meta-analysis of randomized clinical trials. Physical Ther. 1992;72:483-491.
Schneider WL, Hailey D. Low level laser therapy for wound healing. Alberta Heritage Foundation for Medical Research (AHFMR). Edmonton, AB: AHFMR; 1999.
Cullum N, Nelson EA, Flemming K, et al. Systematic reviews of wound care management: (5) beds; (6) compression; (7) laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy. Health Technol Assess. 2000;4(21):1-237.
Lagan KM, Clements BA, McDonough S, et al. Low intensity laser therapy (830nm) in the management of minor postsurgical wounds: A controlled clinical study. Lasers Surg Med. 2001;28(1):27-32.
Flemming KA, Cullum NA, Nelson EA. A systematic review of laser therapy for venous leg ulcers. J Wound Care. 1999;8(3):111-114.
Horwitz LR, Burke TJ, Carnegie D. Augmentation of wound healing using monochromatic infrared energy. Exploration of a new technology for wound management. Adv Wound Care. 1999;12(1):35-40.
Gupta AK, Filonenko N, Salansky N, et al. The use of low energy photon therapy (LEPT) in venous leg ulcers: A double-blind, placebo-controlled study. Dermatol Surg. 1998;24(12):1383-1386.
Gogia PP, Hurt BS, Zirn TT. Wound management with whirlpool and infrared cold laser treatment. A clinical report. Phys Ther. 1988;68(8):1239-1242.
Canadian Coordinating Office of Health Technology Assessment (CCOHTA). Photonic stimulation for the treatment of chronic pain. Pre-assessment No. 11. Ottawa, ON; CCOHTA; November 2002.
Leonard DR, Farooqi MH, Myers S. Restoration of sensation, reduced pain, and improved balance in subjects with diabetic peripheral neuropathy: A double-blind, randomized, placebo-controlled study with monochromatic near-infrared treatment. Diabetes Care. 2004;27(1):168-172

Blue Cross

Medical Policy: 01.01.08
Original Effective Date: October 2003
Reviewed: February 2006
Revised:

This policy applies to all products unless specific contract limitations, exclusions or exceptions apply. Please refer to the member's benefit certificate language for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply.

Description:

Monochromatic infrared energy (MIRE) refers to light at a wavelength of 880 nm. MIRE can be delivered through pads containing an array of superluminous infrared diodes emitting pulsed near-infrared irradiation. The pads can be placed on the skin and the infrared energy is delivered in a session lasting from 30-45 minutes. The Anodyne® Therapy System is a MIRE device that received marketing clearance through the U.S. Food and Drug Administration (FDA) in 1994. MIRE devices have been investigated as a treatment of multiple conditions including cutaneous ulcers, diabetic neuropathy, musculoskeletal and soft tissue injuries, and myofascial pain. The proposed mechanism of action is unknown.

Policy:

Skin contact monochromatic infrared energy is considered investigational as a technology to treat chronic, non-healing cutaneous ulcers, diabetic neuropathy, peripheral neuropathy and miscellaneous musculoskeletal disorders because it has not been adequately demonstrated to have any significant therapeutic effect. Benefits are not available for the infrared light system and any related accessories.

Services are not covered:

Skin contact monochromatic infrared energy is considered investigational as a technology to treat chronic, non-healing cutaneous ulcers, diabetic neuropathy, peripheral neuropathy and miscellaneous musculoskeletal disorders because it has not been adequately demonstrated to have any significant therapeutic effect. Benefits are not available for the infrared light system and any related accessories.

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I have also tried many times to find studies relating to lymphedema and have been unable to locate any independent double-blind studies.

Pat
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patoco
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Postby tennesseegal » Sat Jan 13, 2007 12:39 am

Thanks for the info. I am familiar with Anodyne, I am a nurse and we have used it on neuropathy and wounds. However, we had an inservice today where the rep stated it could be used on lymphedema. I couldn't find anything online, and was skeptical about his claims.

Is it common for episodes of cellulitis to increase with MLD and compression? He used to get cellulitis 3-4 times/year without treatment. He started treatment less than 5 months ago and has had 3 episodes, which are more severe than they were before. I have attributed this to the increased fluid movement. Seems like when we start making progress, he gets cellulitis and we have to start all over...very frustrating. Right now I guess I am just looking for other options. Thanks for any help you can give me.
tennesseegal
 
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Postby patoco » Sat Jan 13, 2007 1:12 am

Hi again Tennessee :)

Technically as MLD progresses and the limb size reduces, there should be less cellulitis. However, with lymphedema, "technically" doesn't always fit the bill.

One idea is for your husband to be on a preventative course of daily antibiotics. At least for an extendedperiod of time.

Cellulitis has always been my big nemisis (well until the lymphoma) and I have found that taking a daily antibiotic has tremendously reduced the incident rate and the severity of cellulitis.

Originally, this was proposed to me by my infectious disease doctor.

The three antibiotics I have had the best success with are:

1.) Augmentin
2.) Keflex
3.) Bactrim

Give my best to your husband too :!: :!:

Pat
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