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12 Articles in Volume 12, Issue #3
Alternative Medicine in Chronic Migraine: What Clinicians Need to Know
Classic Central Pain Syndromes: Review of Neurologic Causes of Pain
Effective Treatments for Neuropathic Pain
Electric Current and Local Anesthetic Combination Successfully Treats Pain Associated With Diabetic Neuropathy
HCG and Diabetic Neuropathy
Migraine Treatment From A to Z
Opioid-induced Constipation: Causes and Treatments
Pain Management of Diabetic Neuropathy
Partnering With Parents
PPM Editorial Board Discusses Mental Deterioration in Pain Patients
The Critical Necessity to Diagnose Pain That Is Centralized
Unique Use of Near-Infrared Light Source to Treat Pain

Unique Use of Near-Infrared Light Source to Treat Pain

Pilot study using cosmetic device shows promise in reducing musculoskeletal pain in the foot, ankle, wrist, and knee joints.

Debilitating foot and ankle pain are the bane of many patients. The sufferer often restricts their activity, limits exercise, changes their footwear, and seeks multiple remedies, often without reducing their symptoms. Decreased activity/exercise can result in weight gain and added burden on the foot. The causes of foot and ankle pain are numerous, with many treatments offering varying degrees of invasiveness and effectiveness.

One potential less-invasive treatment option is the use of low-energy light. Low-energy lightwaves have been used successfully for 40 years to speed healing of wounds, decrease pain, and decrease inflammation.1-19 This article evaluates the use of a near-infrared (IR) light source (StarLux-IR Deep Dermal, Fractional Heating from Palomar Medical Technologies, Inc., Burlington, Massachusetts) in ameliorating non-fracture foot and ankle pain (see above image).

Study Design
Forty patients with acute and/or chronic foot (n=36), ankle (n=1), hand/wrist (n=2), or knee (n=1) pain underwent between 1 to 10 treatments with the near-IR device. The time interval between treatment sessions was variable and determined by patient availability. Treatments were ended when a patient was pain free or had significant pain reduction, or when the patient simply decided to stop.

The device produces a non-coherent light source that was developed as a “skin-tightening” cosmetic device with output wavelengths of 850 to 1,350 nm and contact cooling (See Glossary of Terms, page 47). For this study, it was used at its lowest setting, 2.5-second pulse and fluence of 30 J/cm2. The device has aggressive contact cooling and will not fire or will stop firing if good skin contact is not maintained. Thin contact oil is used on the treated area of skin as a coupler for the contact cooling and for better light transmittance. Non-overlapping pulses were used, but for each treatment session multiple passes were performed, usually 3 or 4.

Patients were followed for up to 9 months. Conditions treated included acute and chronic non-fracture musculoskeletal injuries, plantar fasciitis, tendonitis, shin splints, acute hand and wrist sprain, carpal tunnel syndrome, and chronic knee injury pain. Pain assessment used the Wong-Baker FACES Pain Rating Scale, a subjective patient pain assessment conducted before and after each treatment using a scale of 0-5 (5 being worst).20 Pain reduction was deemed as the percentage reduction from baseline on this scale.

Seven patients were treated only with the IR device. Thirty-three patients had other treatment modalities before the course of near-IR treatments. Previous treatment modalities were only partially effective and in most cases these treatment modalities had been used for months. All other treatment modalities were stopped seven or more days before the commencement of near-IR treatment except for non-steroidal anti-inflammatory drugs (NSAIDs; n=8), which had been ineffective monotherapy prior to the near-IR.

The IR treatments were not covered by insurance and patients paid separately for each treatment.

Results
All but one patient reported a significant decrease in pain, ranging from 40% to 100% reduction. In most cases, the pain reduction started within hours after the first treatment (34 patients) or second near-IR treatment (39 patients) (Figure 1 and Table 1, pages 40-41). Two patients had significant pain reduction two weeks after the first treatment, but dropped out of the study.

Pain reduction appeared to be long lasting. Weeks and even months later, all patients with pain reduction were still either pain free or had markedly reduced pain. Many were able to return to exercise or wearing high heels. No complications occurred during or after any treatment. No patient stopped treatment because of discomfort during treatment.

Discussion
Low-level visible light has been used safely and effectively for more than 40 years to decrease pain, reduce inflammation, and promote tissue regeneration.1-19 The mechanism of “photobiostimulation” by low-level visible and/or IR “light” is still not completely resolved and higher-level irradiation can have the opposite effect at the same wavelength—a biphasic dose response.5 Near-IR wavelengths have been shown to accelerate wound healing in fibroblast cell cultures, without measurable temperature change.8

Numerous parameters can influence the efficacy and safety of “phototherapy.”5 Results can be evaluated with various objective and subjective parameters. More fluence can be better or worse depending on the condition being treated and confounding factors. Although, by definition, fluence = J/cm2, the identical fluence may be the product of a short pulse and high intensity or a long pulse and lower intensity—the effects may be very different.In our choice of the near-IR for an off-label use, we had a reasonable expectation that it might be beneficial for pain reduction and even facilitation of healing based on photobiostimulation-type effects of these wavelengths.5 We expected and found no complications at the low setting used.

The near-IR laser was developed for and approved by the FDA as a skin-tightening device through soft tissue coagulation and collagen remodeling. Typical treatment parameters for skin tightening are 10-second pulse duration and fluence of 60 to 120 J/cm2. The near-IR spectrum has an expected penetration depth shown in Figure 2. About 1% of the light is present at a depth of 3 cm.21-23

Cosmetic treatment parameters are very different from the use of the near-IR in this study, in which it was used at its lowest setting, 2.5-second pulse and fluence of 30 J/cm2. For pain reduction, the areas of injury being treated may be more than 1 cm deep, but the effect we need is not based on heating and thermal injury, so for this effect minimal penetration, with minimal light intensity, may not only be sufficient, but desirable. Although the optimal setting and wavelengths are to be determined, it is reasonable to expect that a very low fluence might be sufficient.2,5,9,10,15-17 The expected fluence at the required depths to decrease inflammation, decrease pain, and possibly speed healing in the affected areas was hoped to—and based on the results appears to have been sufficient to—at least decrease pain, with a significant reduction in pain scores seen in all but one patient.

While it is simple to maintain good contact between the device and the skin surface on flatter and padded areas of the body, the flat contact surface of the hand piece is less congruent in curved areas with less soft tissue such as a bony protuberance as on the back of the hand. In these cases, additional care must be used; the device has an attachment that blocks the light from one half of the hand piece, facilitating contact in difficult areas.

In this study, using these settings during each pulse, the patient feels the cold cooling surface against the treated area. They may feel warmth, but should feel no pain. If pain is felt, that pulse should be stopped. Even at the lowest setting, there is the theoretical potential of causing a blister if contact cooling is lost, especially in darker skin types and after recent sun exposure or on sun-tanned skin. This is also why non-overlapping pulses are used to avoid heat build-up. There were no complications in this study, no patient felt pain, and no patient discontinued a treatment session for any reason.

One reason we conducted this study was because one of the patients had recurrent pain from carpal tunnel syndrome. This patient believed aggressive treatment should be a last resort. Other treatment that had been tried but failed included physical therapy, NSAIDs, ultrasound, electrogalvanic stimulation [EGS], wrist splints, and steroid/lidocaine injections, but the patient’s pain persisted and/or recurred. The near-IR was then tried and had immediate benefit for this patient. The immediate pain reduction enabled the patient to resume activities that may have caused the pain in the first place, and repeat near-IR treatments again provided significant relief. A second patient sustained misuse injury to both hands at different times (poor golf/tennis grip); the near-IR provided remarkable benefit after weeks of pain in the left hand and slightly less dramatic benefit in a subsequent acute injury to the right hand.

Caveat of the Study
This was not a placebo-controlled study; it would have been difficult to have a placebo for a device that emits a bright light (a small percentage of the light is in the visible range), has a frigid tip, and makes noise as it is firing. Most of the patients did pay for their treatment. In a private office setting, it would be especially difficult to have patients return repeatedly for an attempt at placebo treatments. Concomitant treatment with other modalities is a confounding factor, but no patient had other treatment modalities within seven days of the near-IR (except NSAIDs). However, in all cases, the other treatments provided only partial relief. Indeed, 33 patients had protracted pain for months to years, which was resistant to other treatment modalities. All but one patient, including the authors, responded rapidly and significantly to the near-IR in one or two treatments. Additional near-IR treatments were associated with a further decrease in pain in 14 patients (Table 1). Patients’ activities were not curtailed during the study and any decrease in pain might well encourage an increase in activity, stress on the injured area, and possible aggravation of the injury. This was certainly the case for both authors of this paper. Repeat treatments were again effective in all cases.

The patients had to pay for and consent to each treatment separately and their willingness to repeatedly do so would seem to support the treatment’s benefit. Patients had differing numbers of treatments and varying intervals between treatments, yet pain reduction was achieved in all but one patient. Most treatments were for foot pain, yet the pain reduction achieved for the two hand injury patients and one knee patient suggests the Near-IR can be used in a broader spectrum of musculoskeletal pain.

The spectrum of the near-IR and the absorption of various chromophores (blood, melanin, and water) are shown in Figure 3. Further information on the near-IR device can be obtained at the manufacturer’s Website (www.PalomarMedical.com).

Conclusions
The broad-spectrum near-IR device is a safe and efficacious method to provide significant reduction of musculoskeletal pain in the feet and possibly the ankles, hands, wrists, and knees. This is an off-label use of an FDA-approved device. The possibility of attaining similar benefits with other devices, be they intense pulsed light (IPL), lasers, light-emitting diodes (LEDs), radiofrequencies (RFs), or with high- or low-energy output, remains to be investigated.

The success of our novel use of this existing device suggests the potential of a multitude of other light sources for use in the treatment of pain relief and wound healing, either already in use or with the potential for development—possibly even the use of prescription or over-the-counter devices. The future is literally bright.

Glossary of Terms

Coherent “light”: Electromagnetic radiation can be described as waves. When all the waves, peaks, and valleys are lined up, they are “in phase” with each other, at which point the light is considered coherent.

Contact cooling: When high intensity light from a laser or IPL is used, it causes heat by interacting with a target chromophore (the part of a molecule that gives it its color). The light penetrates the skin to a variable depth. If the skin is cooled, it will reach a lower peak temperature than the deeper tissue. One method of cooling the skin uses a man-made sapphire, with chilled water circulating through it, placed in contact with the skin—this is contact cooling. A sapphire is used rather than glass because the sapphire has excellent transmission of “light” and cooling to the skin.

High- versus low-energy output: High-energy devices work by interacting with a target chromophore causing selective heating of the cells containing the chromophore. Low-energy devices also interact with a target, but they do not work by heating. The device used in this study, the StarLux-IR, was used at its lowest setting, and the mechanism of action was primarily not by heating. The IR light is scattered and absorbed in epidermis, dermis, and subcutaneous fat with primarily a deeper photobiological effect (see below). Light-emitting diodes (LEDs) are other devices that usually work without heating.

Infrared: The “invisible light” with wavelengths just longer than red light. Thermal (heat) radiation near room temperature 740 nm to about 1 mm. Near-infrared is defined as 740 to 2,500 nm; mid-infrared: 2,500 to 25,000 nm; and far-infrared: 25,000 nm to 106 nm (1 mm).

Intense Pulsed Light (IPL): Usually using photoflash technology, a very intense pulse of broad spectrum, non-coherent light is produced. This is usually a broad beam of light that disperses (spreads out quickly). A “cut-off filter” is commonly used to markedly reduce the light below a chosen wavelength. The result is a very intense pulse of light of a certain “color” or range of wavelengths, not one nearly pure wavelength such as produced by a LASER.

LASER: Acronym for Light Amplification by Stimulated Emission of Radiation. Usually a pencil-shaped beam of coherent light consisting of a narrow range of wavelengths (visible or invisible).

Light: The part of the electromagnetic spectrum visible to the human eye. Wavelengths range from about 380 nm (violet end) to about 740 nm (red end). Sometimes “light” is used for any part of the electromagnetic spectrum.

Near-Infrared (StarLux-IR): Produces both a photothermal effect and photobiological effect. The photothermal portion of the light pulse is predominantly located in the epidermis, dermis, and fat layer. The percentage of thermal effects below these layers is minimal, but is dependent on the thickness of the overlying skin and fat. The photobiological effects predominate in deeper tissue, such as muscle, and appear to occur on the cellular level. The combination of both effects added considerably to the reduction of pain experienced by the patients.

Last updated on: May 1, 2012
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