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A Study of the Effectiveness of Near Infrared Light for the Treatment of Painful Peripheral Neuropathy - Article


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Hereditary neuropathy with liability to pressure palsies

compression neuropathy; entrapment neuropathy; familial pressure sensitive neuropathy; HNPP; inherited tendency to pressure palsies; tomaculous neuropathy

Clinical Trial: A Study of the Effectiveness of Near Infrared Light for the Treatment of Painful Peripheral Neuropathy

This study is currently recruiting patients.
Verified by Mayo Clinic July 2005

Sponsors and Collaborators: Mayo Clinic
Scott and White Hospital & Clinic
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00125268

Purpose

The purpose of this study is to determine if near infra-red light therapy is effective in decreasing pain in patients with painful peripheral neuropathy
Condition Intervention Phase
Peripheral Neuropathy
  Device: monochromatic near-infrared photo energy emitting device
 Phase III

MedlinePlus related topics:  Peripheral Nerve Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, 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: 
Primary Outcomes: The proportion of subjects that have a greater than or equal to forty percent decrease on the visual analog pain scale at the end of four weeks of treatment.
Secondary Outcomes: 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.; 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.; 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.; The proportion of subjects with foot dorsum sweat volume increases of greater than ten percent over baseline in the QSART at the end of four weeks of treatment.; The proportion subjects with great toe vibration detection or heat/VAS value percentile decreases of greater than ten percent over baseline percentiles in CASE IV at the end of four weeks of treatment.
Expected Total Enrollment:  60

Study start: July 2005;  Expected completion: December 2007
Last follow-up: December 2006;  Data entry closure: March 2007

Pain is a very common symptom, between 65-80%, in patients with peripheral neuropathy. This study is designed to evaluate the effectiveness of near infra-red 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   -   85 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Adults age 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 EMG, quantitative sensory testing of the foot with CASE IV, quantitative sudomotor 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:

  • Pregnancy 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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00125268

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

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

Study chairs or principal investigators

Matthew A Butters, MD,  Principal Investigator,  Mayo Clinic   

More Information

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.

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.

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.

Study ID Numbers:  927-05 00
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125268
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-02


Source: ClinicalTrials.gov
Cache Date: August 3, 2005


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Page Updated: September 6, 2005
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