Evaluation of green light exposure on headache frequency and quality of life in migraine patients: A preliminary one-way cross-over clinical trial.

BACKGROUND: Pharmacological management of migraine can be ineffective for some patients. We previously demonstrated that exposure to green light resulted in antinociception and reversal of thermal and mechanical hypersensitivity in rodent pain models. Given the safety of green light emitting diodes, we evaluated green light as a potential therapy in patients with episodic or chronic migraine. MATERIAL AND METHODS: We recruited (29 total) patients, of whom seven had episodic migraine and 22 had chronic migraine. We used a one-way cross-over design consisting of exposure for 1-2 hours daily to white light emitting diodes for 10 weeks, followed by a 2-week washout period followed by exposure for 1-2 hours daily to green light emitting diodes for 10 weeks. Patients were allowed to continue current therapies and to initiate new treatments as directed by their physicians. Outcomes consisted of patient-reported surveys. The primary outcome measure was the number of headache days per month. Secondary outcome measures included patient-reported changes in the intensity and frequency of the headaches over a two-week period and other quality of life measures including ability to fall and stay asleep, and ability to perform work. Changes in pain medications were obtained to assess potential reduction. RESULTS: When seven episodic migraine and 22 chronic migraine patients were analyzed as separate cohorts, white light emitting diodes produced no significant change in headache days in either episodic migraine or chronic migraine patients. Combining data from the episodic migraine and chronic migraine groups showed that white light emitting diodes produced a small, but statistically significant reduction in headache days from (days ± SEM) 18.2 ± 1.8 to 16.5 ± 2.01 days. Green light emitting diodes resulted in a significant decrease in headache days from 7.9 ± 1.6 to 2.4 ± 1.1 and from 22.3 ± 1.2 to 9.4 ± 1.6 in episodic migraine and chronic migraine patients, respectively. While some improvement in secondary outcomes was observed with white light emitting diodes, more secondary outcomes with significantly greater magnitude including assessments of quality of life, Short-Form McGill Pain Questionnaire, Headache Impact Test-6, and Five-level version of the EuroQol five-dimensional survey without reported side effects were observed with green light emitting diodes. Conclusions regarding pain medications reduction with green light emitting diode exposure were not possible. No side effects of light therapy were reported. None of the patients in the study reported initiation of new therapies. DISCUSSION: Green light emitting diodes significantly reduced the number of headache days in people with episodic migraine or chronic migraine. Additionally, green light emitting diodes significantly improved multiple secondary outcome measures including quality of life and intensity and duration of the headache attacks. As no adverse events were reported, green light emitting diodes may provide a treatment option for those patients who prefer non-pharmacological therapies or may be considered in complementing other treatment strategies. Limitations of this study are the small number of patients evaluated. The positive data obtained support implementation of larger clinical trials to determine possible effects of green light emitting diode therapy.This study is registered with clinicaltrials.gov under NCT03677206.

Green Light Exposure Improves Pain and Quality of Life in Fibromyalgia Patients: A Preliminary One-Way Crossover Clinical Trial.

OBJECTIVE: Fibromyalgia is a functional pain disorder in which patients suffer from widespread pain and poor quality of life. Fibromyalgia pain and its impact on quality of life are not effectively managed with current therapeutics. Previously, in a preclinical rat study, we demonstrated that exposure to green light-emitting diodes (GLED) for 8 hours/day for 5 days resulted in antinociception and reversal of thermal and mechanical hypersensitivity associated with models of injury-related pain. Given the safety of GLED and the ease of its use, our objective is to administer GLED as a potential therapy to patients with fibromyalgia. DESIGN: One-way crossover clinical trial. SETTING: United States. METHOD: We enrolled 21 adult patients with fibromyalgia recruited from the University of Arizona chronic pain clinic who were initially exposed to white light-emitting diodes and then were crossed over to GLED for 1 to 2 hours daily for 10 weeks. Data were collected by using paper surveys. RESULTS: When patients were exposed to GLED, but not white light-emitting diodes, they reported a significant reduction in average pain intensity on the 10-point numeric pain scale. Secondary outcomes were assessed by using the EQ-5D-5L survey, Short-Form McGill Pain Questionnaire, and Fibromyalgia Impact Questionnaire and were also significantly improved in patients exposed to GLED. GLED therapy was not associated with any measured side effects in these patients. CONCLUSION: Although the mechanism by which GLED elicits pain reduction is currently being studied, these results supporting its efficacy and safety merit a larger clinical trial.

Exploring the Role of Chronic Pain Clinics: Potential for Opioid Reduction.

BACKGROUND: The management of chronic nonmalignant pain with high-dose opioids has partially contributed to the current opioid epidemic, with some responsibility shared by chronic pain clinics. Traditionally, both primary care providers and patients used chronic pain clinics as a source for continued medical management of patients on high-dose opioids, often resulting in tolerance and escalating doses. Although opioids continue to be an important component of the management of some chronic pain conditions, improvement in function and comfort must be documented. Pain clinics are ideally suited for reducing opioid usage while improving pain and function with the use of a multimodal approach to pain management. We assessed whether the application of multimodal treatment directed by pain specialists in a pain clinic provides for improved function and reduced dosages of opioid analgesics. OBJECTIVE: We evaluated the role of a pain clinic staffed by fellowship-trained pain physicians in reducing pain and opioid use in chronic nonmalignant pain patients. STUDY DESIGN: This study used a retrospective design. SETTING: The research took place in an outpatient pain clinic in a tertiary referral center/teaching hospital. METHODS: Of 1268 charts reviewed, 296 patients were on chronic opioids at the time of first evaluation. After a thorough evaluation, the patients were treated with nonopioid pharmacotherapy and interventional pain procedures as necessary. The data utilized from patients' latest follow-up visit included current pain level using the Numerical Rating Scale (NRS-11), opioid usage, and various functional parameters. RESULTS: NRS-11 scores decreased by 33.8% from 6.8 (± 0.1)/10 to 4.5 (± 0.2)/10. The pain frequency and number of pain episodes improved by 36.8 ± 2 and 36.2 ± 2.1, respectively. Additionally, the ability to sleep, work, and perform chores significantly improved. Total opioid use decreased by about 55.4% from 53.8 ± 4 to about 24 ± 2.8 MME/patient/day. LIMITATION: This study is not a randomized prospective controlled study. The patients analyzed are still getting therapy and their pain status may change. Some opioids are underrepresented in the analyzed cohort. Finally, this study lacks in-depth stratification by type of pain, age, gender, and duration of opioid use. CONCLUSION: Chronic pain clinics can play a pivotal role in reducing opioid usage while improving pain and function in patients on chronic opioids. We wish to emphasize the importance of allocating resources toward nonopioid treatments that may improve the function and well-being of patients. KEY WORDS: Pain clinic, pain management, multimodal pain management, chronic pain, opioid reduction, improved pain, improved functional capacity.

Does Everything That's Counted Count? Value of Inflammatory Markers for Following Therapy and Predicting Outcome in Diabetic Foot Infection.

To assess the severity of inflammation associated with diabetic foot infection (DFI), values of inflammatory markers such as white blood count (WBC), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and neutrophil to lymphocyte ratio (NLR) are often measured and tracked over time. It remains unclear if these markers can aid the clinician in the diagnosis and management of DFI, and ensure more rational use of antibiotics. Hospitalized adult patients (n = 379) with DFI were retrospectively assessed for abnormal inflammatory markers, correlation between values of inflammatory markers, and clinical diagnosis on initial admission and on last follow-up. At admission, WBC, ESR and NLR were each elevated in patients with osteomyelitis and only ESR was significantly elevated in patients with soft tissue infection only. Only WBC was significantly elevated in patients with osteomyelitis compared with uninfected diabetic feet on last follow-up. Considering the predictive performance of these inflammatory markers, they demonstrated excellent positive predictive value at admission, and excellent negative predictive value at the last follow-up visit. Moreover, the number of elevated markers was further associated with probability of infection both at admission and last follow-up.

How can I maintain my patient with diabetes and history of foot ulcer in remission?

Patients with diabetes and previous history of ulceration occupy the highest category of risk for reulceration and amputation. Annual recurrence rates of diabetic ulcerations have been reported as high as 34%, 61%, and 70% at 1, 3, and 5 years, respectively, with studies reporting 20% to 58% recurrence rate within 1 year. As the ever growing epidemic of diabetes expands globally, this sequelae of diabetic complication will continue to require increasing resources from the healthcare community to effectively manage. Recent data suggest that removal of preventative podiatric care from statewide reimbursement systems lead to significant and sustained increases in hospital admission (37%), charges (38%), length of stay (23%), and severe aggregate outcomes including amputation, sepsis and death (49%). The addition of comorbidities such as peripheral artery disease, poor nutrition, and non-adherence to preventive therapies not only increase a patient's likelihood for ulcer recurrence, but also cost of care and certainty of hospital admission. Currently, numerous efforts, guidelines, and industry generated products exist to prolong remission from ulceration; however, the clinical science for treating this patient population calls for much more effort. Despite this, data continue to suggest to demonstrate that appropriate follow-up care, shoe and insole modification, and patient education play a central role in reducing reulceration and amputation. Novel modalities for offloading and wearable sensor technologies offer the advantage of round-the-clock, patient specific and active response healthcare. These have the potential to detect, or even prevent, many wounds before they begin.