Light Therapy and Exercise for PAD
(ENLIGHTEN PAD Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northwestern University
Disqualifiers: Amputation, Critical limb ischemia, Wheelchair, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The ENLIGHTEN PAD Trial will collect preliminary data to test whether daily 660 nm light treatment of the lower extremities immediately before home-based walking exercise sessions improves six-minute walk distance at 4-month follow-up, compared to sham light, in people with lower extremity peripheral artery disease (PAD).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Light Therapy and Exercise for PAD?
Research shows that light therapy, including low-level laser and LED therapies, can help with healing and reducing inflammation in various conditions. It has been used effectively for pain management, wound healing, and improving blood flow, which may suggest potential benefits for conditions like PAD (peripheral artery disease).
12345Is light therapy safe for humans?
Light therapy, also known as photobiomodulation, has been used safely in various treatments, including pain management and dental procedures. It is generally considered safe, with studies showing positive effects like pain reduction and healing stimulation without significant adverse effects.
12567How does Far Red Light Therapy differ from other treatments for PAD?
Far Red Light Therapy is unique because it uses red and near-infrared light to stimulate healing, reduce pain, and decrease inflammation without the need for drugs or invasive procedures. This non-invasive approach enhances cellular energy production and promotes tissue repair, which is different from traditional treatments that may rely on medication or surgery.
12689Eligibility Criteria
This trial is for individuals with peripheral artery disease (PAD), which often causes difficulty walking and limited mobility due to poor blood flow in the legs. Participants should be able to perform home-based exercises and have no conditions that would interfere with light therapy.Inclusion Criteria
I am 50 years old or older.
I have been diagnosed with PAD based on specific tests.
Exclusion Criteria
I have a current foot ulcer on the bottom of my foot.
I use a wheelchair or walker to move around.
Failure to successfully complete the study run-in
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive daily 660 nm light treatment of the lower extremities immediately before home-based walking exercise sessions
16 weeks
Daily sessions (home-based)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The ENLIGHTEN PAD Trial is testing if shining a special red light on the lower legs before walking exercises can improve walking distance after four months, compared to using a fake light treatment in people with PAD.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Far red light therapy + home-based walking exerciseExperimental Treatment2 Interventions
Subgroup of participants receiving home-based walking exercise and the 670 nm far red light device
Group II: Sham therapy + home-based walking exercisePlacebo Group2 Interventions
Subgroup of participants receiving home-based walking exercise and the sham light device, far red light device covered with blue filter paper to block 670 nm light, resulting in mean power generated of 0.24 mW/cm2, compared to 26.3 mW/cm2 for the intervention, a 100-fold difference.
Far Red Light Therapy is already approved in United States for the following indications:
🇺🇸 Approved in United States as Red Light Therapy for:
- Pain relief
- Muscle and joint aches
- Arthritis pain and stiffness
- Tendinitis pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern UniversityChicago, IL
Loading ...
Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
References
Perspective on Broad-Acting Clinical Physiological Effects of Photobiomodulation. [2019]Research into photobiomodulation reveals beneficial effects of light therapy for a rapidly expanding list of medical conditions and illnesses. Although it has become more widely accepted by the mainstream medicine, the effects and mechanisms of action appear to be poorly understood. The therapeutic benefits of photobiomodulation using low-energy red lasers extend far beyond superficial applications, with a well-described physics allowing an understanding of how red lasers of certain optimum intensities may cross the cranium. We now have a model for explaining potential therapeusis for applications in functional neurology that include stroke, traumatic brain injury, and neurodegenerative conditions in addition to the currently approved functions in lipolysis, in onychomycosis treatment, and in pain management.
Photobiomodulation in Periodontology and Implant Dentistry: Part 2. [2020](Part 1 of this article can be located at www.liebertpub.com/doi/10.1089/photob.2019.4710.) Objective: Finding evidence-based treatment strategies for low-level light therapy and the correct incorporation of these treatment methods in the clinical practice of periodontics. Background: Photobiomodulation has been shown to have biostimulatory, anti-inflammatory, and analgesic effects that can be beneficial in periodontal and dental implant treatment procedures. Methods: In this review, we have addressed some clinical questions regarding the potential clinical application of low-level light irradiation and its photobobiomodulatory effects in periodontology and implantology. The literature was searched for in vivo (animal or clinical) articles written in English in four electronic databases of PubMed, Scopus, Google Scholar, and Cochrane Library until April 2019. Only studies with low irradiation doses without any thermal effects used only for their photobiomodulatory purposes were included. Results: We were able to find relevant studies for all of our questions, and positive effects for the application of light therapy were reported in most of the studies. However, there is still a great deal of heterogeneity in terms of study designs and most importantly in light irradiation devices and the parameters used. Due to this issue, it was not possible to reach specific evidence-based irradiation protocols for the questions addressed in this review. Conclusions: Based on our search results, an obvious positive effect of low-level light therapy on stimulation of healing of periodontal soft and hard tissues and reduction of inflammation can be seen. Future well-designed randomized control studies with the same irradiation settings and systematic reviews evaluating the studies found on the questions mentioned are necessary to reach evidence-based recommendations.
Photobiomodulation effects on keratinocytes cultured in vitro: a critical review. [2020]Photobiomodulation therapy (PBMT) has been widely used for the promotion of tissue repair. Despite these therapeutic benefits, in some cases, PBMT appears to be unsuccessful, and the strongest hypothesis is that this failure is due to inadequate light dosimetry and wavelengths. The objective of the present critical review was to evaluate the effects of PBMT on cultured keratinocytes using blue, red, or near-infrared light categorized into arbitrary ranges of energy density (0.1-5.0, 5.1-10.0, 10.1-15.0, and over 15.0 J/cm2). The electronic searches were conducted in PubMed, Web of Science, Scopus and LILACS databases, and included LASER or LED devices. A total of 55 articles evaluating the effects of PBMT on cell viability, proliferation, migration, and cytokine and growth factor production were included. Overall, the studies failed to provide detailed information about light dosimetry or detailed experimental conditions. The vast majority of the energy densities tested produced unmodified results regardless of the wavelength applied. However, it was possible to observe that red and near-infrared light had more stimulatory effects than blue light. In addition, for all parameters analyzed, favorable outcomes were mostly obtained in the range of 0.1-5.0 J/cm2. The less explored energy densities were within the 10.1-15.0 J/cm2 range. Energy densities above 15.0 J/cm2 were ineffective or tended to cause cell death. The heterogeneity of the data does not allow us to define a PBMT range setting protocol that would have beneficial effects on keratinocytes.
Is light-emitting diode phototherapy (LED-LLLT) really effective? [2022]Low level light therapy (LLLT) has attracted attention in many clinical fields with a new generation of light-emitting diodes (LEDs) which can irradiate large targets. To pain control, the first main application of LLLT, have been added LED-LLLT in the accelerated healing of wounds, both traumatic and iatrogenic, inflammatory acne and the patient-driven application of skin rejuvenation. Rationale and Applications: The rationale behind LED-LLLT is underpinned by the reported efficacy of LED-LLLT at a cellular and subcellular level, particularly for the 633 nm and 830 nm wavelengths, and evidence for this is presented. Improved blood flow and neovascularization are associated with 830 nm. A large variety of cytokines, chemokines and macromolecules can be induced by LED phototherapy. Among the clinical applications, non-healing wounds can be healed through restoring the collagenesis/collagenase imbalance in such examples, and 'normal' wounds heal faster and better. Pain, including postoperative pain, postoperative edema and many types of inflammation can be significantly reduced. Experimental and clinical evidence: Some personal examples of evidence are offered by the first author, including controlled animal models demonstrating the systemic effect of 830 nm LED-LLLT on wound healing and on induced inflammation. Human patients are presented to illustrate the efficacy of LED phototherapy on treatment-resistant inflammatory disorders.
Clinical and scientific recommendations for the use of photobiomodulation therapy in exercise performance enhancement and post-exercise recovery: current evidence and future directions. [2022]There is about ten years since the first randomized controlled trial looking for the effects of photobiomodulation therapy using low-level laser therapy and/or light emitting diodes therapy in athletic performance enhancement was published. Since then, the knowledge in this field has increasing exponentially.
Photobiomodulation: The Clinical Applications of Low-Level Light Therapy. [2022]Low-level light therapy (LLLT) is a recent addition to the pantheon of light-based therapeutic interventions. The absorption of red/near-infrared light energy, a process termed "photobiomodulation," enhances mitochondrial ATP production, cell signaling, and growth factor synthesis, and attenuates oxidative stress. Photobiomodulation is now highly commercialized with devices marketed directly to the consumer. In the gray area between the commercial and therapeutic sectors, harnessing the clinical potential in reproducible and scientifically measurable ways remains challenging.
Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. [2019]Low-level laser therapy (LLLT) is a form of light therapy that triggers biochemical changes within cells. Photons are absorbed by cellular photoreceptors, triggering chemical alterations and potential biochemical benefits to the human body. LLLT has been used in pain management for years and is also known as cold laser therapy, which uses low-frequency continuous laser of typically 600 to 1000 nm wavelength for pain reduction and healing stimulation. Many studies have demonstrated analgesic and anti-inflammatory effects provided by photobiomodulation in both experimental and clinical trials.
The nuts and bolts of low-level laser (light) therapy. [2022]Soon after the discovery of lasers in the 1960s it was realized that laser therapy had the potential to improve wound healing and reduce pain, inflammation and swelling. In recent years the field sometimes known as photobiomodulation has broadened to include light-emitting diodes and other light sources, and the range of wavelengths used now includes many in the red and near infrared. The term "low level laser therapy" or LLLT has become widely recognized and implies the existence of the biphasic dose response or the Arndt-Schulz curve. This review will cover the mechanisms of action of LLLT at a cellular and at a tissular level and will summarize the various light sources and principles of dosimetry that are employed in clinical practice. The range of diseases, injuries, and conditions that can be benefited by LLLT will be summarized with an emphasis on those that have reported randomized controlled clinical trials. Serious life-threatening diseases such as stroke, heart attack, spinal cord injury, and traumatic brain injury may soon be amenable to LLLT therapy.
Photobiomodulation (Therapeutic Lasers): An Update and Review of Current Literature. [2023]Photobiomodulation therapy, also commonly known as laser therapy, continues to grow in popularity in veterinary medicine. It is the use of red and near-infrared light to simulate healing, relieve pain, and reduce inflammation. The potential variety of conditions for which it can be used as an adjunctive, non-invasive modality has propelled its use in both veterinary rehabilitation, sports medicine, and general practice. In the last decade, clinical research has grown with increasing evidence for efficacy for some conditions but mixed to limited in others and many conditions not represented.