Peripheral Neuropathy Clinical Trial
Official title:
Pilot, Single Center, Randomized, Double Blind, Placebo Controlled, Single Crossover Treatment Trial Using Low Level Laser Therapy (LLLT) for Treatment of Chemotherapy Induced Peripheral Neuropathy
The purpose of this research study is to determine if treatment with Low Level Laser Therapy (LLLT) is effective in treating the pain, numbness or tingling patients are experiencing following their chemotherapy. The investigators would also like to know the number of treatments that were needed in order to reduce their symptoms.
LLLT is a technique of applying a low energy or low-level laser to tissue. It is used to
trigger tissue to increase cellular production by giving off a low-level, or cold light
energy. This low level energy passes through the skin, into the cell membrane producing a
process called photobiostimulation. LLLT works by capturing and increasing the beneficial
wavelengths of light. These lasers do not cut or burn, but instead penetrate into the skin.
This process has multiple effects on cells and can enhance the body's natural regenerative
functions. It can also stimulate the release of endorphins and collagen. Endorphins work as
"natural pain relievers" and are produced by the body during strenuous workouts, excitement
and pain. Collagen is a natural substance within body tissues.
This is a single center trial conducted at Legacy Health System. Twenty patients from Legacy
Health System with chemo-induced peripheral neuropathy will be enrolled in this study. Arm 1
will receive LLLT twice a week for a total of eight weeks. Arm 2 will follow a crossover
study design where patients will receive sham (fake) LLLT twice a week for the first four
weeks, followed by true LLLT twice a week for four weeks, (total of 8 weeks). Each patient
in Arm 2 will serve as his or her own comparison for the purpose of examining the effects of
LLLT. Both arms will have a follow-up visit following the last treatment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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