Near Infrared Light for the Treatment of Painful Peripheral Neuropathy - Full Text View

Sponsors and Collaborators:	Mayo Clinic Anodyne Therapy, LLC
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00125268

Purpose

The purpose of this study is to determine if near infrared light therapy is effective in decreasing pain in patients with painful peripheral neuropathy.

Condition	Intervention	Phase
Peripheral Neuropathy	Device: MIRE	Phase III

MedlinePlus related topics: Peripheral Nerve Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase III, Double Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy of Adjunct Monochromatic Near-Infrared Photoenergy (MIRE) in Patients With Painful Axonal Peripheral Neuropathy

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

The proportion of subjects that have a greater than or equal to forty percent decrease on the visual analogue pain scale at the end of four weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of subjects that have a forty percent reduction of pain measured by the neuropathic pain scale at the end of four weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The proportion of subjects that have an improvement of two points or more on the SF-8 at the end of four weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The proportion of subjects that have a reduction of ten or more on the neuropathy impairment score at the end of four weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The proportion of subjects with foot dorsum sweat volume increases of greater than ten percent over baseline in the quantitative sudomotor axon reflex test (QSART) at the end of four weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The proportion of subjects with great toe vibration detection or heat/visual analogue scale (VAS) value percentile decreases of greater than ten percent over baseline percentiles in CASE IV at the end of four weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2005
Estimated Study Completion Date:	December 2010

Arms	Assigned Interventions
Active: Active Comparator subjects will receive active MIRE	Device: MIRE monochromatic near infrared energy Device: MIRE monochromatic near infra red energy
Placebo: Placebo Comparator Subjects will receive placebo MIRE	Device: MIRE Placebo monochromatic near infra red energy

Detailed Description:

Pain is a very common symptom, between 65-80%, in patients with peripheral neuropathy. This study is designed to evaluate the effectiveness of near infrared photoenergy therapy in the treatment of pain in axonal peripheral neuropathy. This will be compared with a placebo(sham) device. Study subjects will receive treatment with the device or the placebo device 3 times per week for 4 weeks. Response will be measured during and after the treatment period.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults ages 18-85; able to give informed consent
Documented painful, distal peripheral neuropathy of idiopathic cause, or related to impaired glucose tolerance or diabetes mellitus.
Neuropathy documented by one of the following studies: nerve conduction studies and needle electromyography (EMG); quantitative sensory testing of the foot with CASE IV; quantitative sudomotor axon reflex test (QSART); neurology specialty examination; and neuropathy impairment score (NIS) of less than 25.
Stable pharmacotherapy for neuropathic pain for at least two weeks.
Optimal pharmacotherapy has been achieved.
Subjects cannot be on COX 2 inhibitors
VAS of greater than or equal to 4/10
Subject has provided written informed consent
Not currently using transcutaneous electrical nerve stimulation (TENS)
Not currently receiving acupuncture

Exclusion Criteria:

Pregnant or likely to become pregnant
Current diagnosis of cancer
Neuropathy impairment score (NIS) of greater than 25.
Diagnosis of severe neuropathy of known etiology for which specific treatment is available (i.e., acute and chronic inflammatory polyradiculoneuropathies, vasculitis, B 12 deficiency).
Unstable diabetes mellitus defined as a HbA1c greater than 9%, and/or 10% of fasting blood sugars greater than 300 mg/dl for the week prior to enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125268

Contacts

Contact: Matthew A Butters, M.D.	480-301-7146	butters.matthew@mayo.edu
Contact: Joseph Verheijde, PhD

Locations

United States, Arizona
Mayo Clinic Scottsdale	Recruiting
Scottsdale, Arizona, United States, 85254
Contact: Matthew A Butters, MD 480-301-7146 butters.matthew@mayo.edu
Contact: Joseph Verheijde, PhD
Principal Investigator: Matthew A Butters, MD
Sub-Investigator: Melissa Eden, DPT
Sub-Investigator: Joseph Verheijde, PhD

Sponsors and Collaborators

Mayo Clinic

Anodyne Therapy, LLC

Investigators

Principal Investigator:

Matthew A Butters, MD

Mayo Clinic

More Information

website of company that provided device to be studied This link exits the ClinicalTrials.gov site

Publications:

Galer BS, Jensen MP. Development and preliminary validation of a pain measure specific to neuropathic pain: the Neuropathic Pain Scale. Neurology. 1997 Feb;48(2):332-8.

Backonja M, Beydoun A, Edwards KR, Schwartz SL, Fonseca V, Hes M, LaMoreaux L, Garofalo E. Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus: a randomized controlled trial. JAMA. 1998 Dec 2;280(21):1831-6.

Dyck PJ, Kratz KM, Lehman KA, Karnes JL, Melton LJ 3rd, O'Brien PC, Litchy WJ, Windebank AJ, Smith BE, Low PA, et al. The Rochester Diabetic Neuropathy Study: design, criteria for types of neuropathy, selection bias, and reproducibility of neuropathic tests. Neurology. 1991 Jun;41(6):799-807.

Holland NR. Idiopathic painful sensory neuropathy. J Clin Neuromusc Dis 2:211-220, 2001

Kochman AB, Carnegie DH, Burke TJ. Symptomatic reversal of peripheral neuropathy in patients with diabetes. J Am Podiatr Med Assoc. 2002 Mar;92(3):125-30.

Leonard DR, Farooqi MH, Myers S. Restoration of sensation, reduced pain, and improved balance in subjects with diabetic peripheral neuropathy: a double-blind, randomized, placebo-controlled study with monochromatic near-infrared treatment. Diabetes Care. 2004 Jan;27(1):168-72.

Mendell JR, Sahenk Z. Painful sensory neuropathy. N Engl J Med 348:1243-1255, 2003

Prendergast JJ, Miranda G, Sanchez M. Improvement of sensory impairment in patients with peripheral neuropathy. Endocr Pract. 2004 Jan-Feb;10(1):24-30.

Koltzenburg M. Painful neuropathies. Curr Opin Neurol. 1998 Oct;11(5):515-21. Review.

Wolfe GI, Trivedi JR. Painful peripheral neuropathy and its nonsurgical treatment. Muscle Nerve. 2004 Jul;30(1):3-19. Review.

Responsible Party:	Mayo Clinic ( Matthew Butters, M.D. Principal Investigator )
Study ID Numbers:	927-05 00
Study First Received:	July 27, 2005
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00125268
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

painful
peripheral
neuropathy
light
therapy

Study placed in the following topic categories:

Neuromuscular Diseases
Peripheral Nervous System Diseases
Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009