A Randomized Clinical Trial of the Effectiveness of Photon Stimulation on Pain, Sensation, and Quality of Life in Patients With Diabetic Peripheral Neuropathy
Accepted 17 June 2009. published online 06 November 2009.
Abstract
Context
Peripheral neuropathy is one of the most common complications of diabetes.
Objectives
The purpose of this study was to evaluate the effects of photon stimulation on pain intensity, pain relief, pain qualities, sensation and quality of life (QOL) in patients with painful diabetic peripheral neuropathy.
Methods
In this randomized, placebo-controlled trial, patients were assigned to receive either four photon stimulations (n=63) or four placebo (n=58) treatments. Pain intensity, pain relief, and pain qualities were assessed using self-report questionnaires. Sensation was evaluated using monofilament testing. QOL was measured using the Medical Outcomes Study Short Form-36 (SF-36). Multilevel regression model analyses were used to evaluate between-group differences in study outcomes.
Results
No differences, over time, in any pain intensity scores (i.e., pain intensity immediately post-treatment, average pain, worst pain) or pain relief scores were found between the placebo and treatment groups. However, significant decreases, over time, were found in some pain quality scores, and significant improvements in sensation were found in patients who received the photon stimulation compared with placebo. In addition, patients in the treatment group reported significant improvements in SF-36 social functioning and mental health scores. Findings from a responder analysis demonstrated that no differences were found in the percentages of patients in the placebo and treatment groups who received 30% or more or 50% or more reduction in pain scores immediately post-treatment. However, significant differences were found in the distribution of the changes in pain relief scores, with most of the patients in the photon stimulation group reporting a slight (28.6%) to moderate (34.9%) improvement in pain relief from the beginning to the end of the study compared with no change in pain relief (43.1%) in the placebo group.
Conclusion
Four treatments with photon stimulation resulted in significant improvements in some pain qualities, sensation, and QOL outcomes in a sample of patients with a significant amount of pain and disability from their diabetes. A longer duration study is needed to further refine the photon stimulation treatment protocol in these chronically ill patients and to evaluate the sustainability of its effects.
aDepartment of Medicine, Veterans Affairs Northern California Health Care System, Martinez, California, USA
bDepartment of Physiological Nursing, University of California, San Francisco, California, USA
cDepartment of Community Health Systems, University of California, San Francisco, California, USA
dHealth Medicine Institute, Lafayette, California, USA
Address correspondence to: Christine Miaskowski, RN, PhD, Department of Physiological Nursing, University of California, 2 Koret Way—N631Y, San Francisco, CA 94143-0610, USA.
This research was supported in part by the Research Service, Department of Veterans Affairs. Additional support was provided by Mr. Thomas C. Barry.
Drs. Swislocki, Edrington, and Cooper report receiving research support for this study. Mr. Bales and Ms. Orth acknowledge their interest in commercializing the photon stimulation device used in this study. Drs. Saputo, Islas, Miaskowski, Ms. West, and Ms. Weisshaupt have nothing to disclose.
ABSTRACT