Near Infrared Light for the Treatment of Painful Peripheral Neuropathy

NCT00125268 | Terminated Phase 3 Results DMC

• 1 other identifier: 927-05 00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if near infrared light therapy is effective in decreasing pain in patients with painful peripheral neuropathy. The hypothesis of the study was that the percentage of subjects with at least 40% improvement in visual analog scale score for pain after 4 weeks of treatment is higher for Monochromatic Near-infrared Photoenergy (MIRE) treatment than for sham treatment.

Conditions

Peripheral Neuropathy

Keywords

painful; peripheral; neuropathy; light; therapy

Outcome Measures

Primary Outcomes (1)

• Percentage 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

  Pain was measured by a 10 cm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. On this scale 0 means no pain and 10 cm means extreme pain. The investigator measures the mark made by the subject in cm and records this for the value of pain.

  baseline, 4 weeks

Secondary Outcomes (2)

• Percentage of Subjects That Have a Forty Percent Reduction of Pain Measured by the Neuropathic Pain Scale at the End of Four Weeks of Treatment

  baseline, 4 weeks

• Percentage of Subjects That Have an Improvement of Two Points or More on the SF-8 at the End of Four Weeks of Treatment

  baseline, 4 weeks

Study Arms (2)

MIRE

ACTIVE COMPARATOR

Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).

Device: MIRE

Sham

SHAM COMPARATOR

Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.

Device: Sham Device

Interventions

MIRE DEVICE

Monochromatic near infrared photo energy (MIRE). A 30-minute application of MIRE results in a radiant exposure of 43.2 joules per square centimeter (J/cm\^2). The design of the flexible pads allows the infrared energy to be delivered perpendicular to and in contact with the involved site. MIRE applied to the skin facilitates the release of a small molecule of the free radical nitric oxide from hemoglobin and other proteins in surrounding tissue. Increased levels of nitric oxide improve the circulation of blood enhancing wound healing and reducing pain.

Also known as: Anodyne Therapy System

MIRE

Sham Device DEVICE

The sham device is non-active but otherwise identical to the study device.

Sham

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Computer Aided Sensory Evaluator (CASE IV); quantitative sudomotor axon reflex test (Quantitative Sweat MeasurementSystem \[Q-Sweat\]); 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 Cyclooxygenase-2 (COX 2) inhibitors
• Pain Visual Analog Scale (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

You may not qualify if:

• 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 hemoglobin A1c (HbA1c) greater than 9%, and/or 10% of fasting blood sugars greater than 300 mg/dl for the week prior to enrollment.

Sponsors & Collaborators

• Mayo Clinic: lead
• Anodyne Therapy, LLC: collaborator

Study Sites (1)

Mayo Clinic Arizona

Scottsdale, Arizona, 85254, United States

Location

Related Publications (10)

• 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. doi: 10.1212/wnl.48.2.332.

  PMID: 9040716 BACKGROUND

• 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. doi: 10.1001/jama.280.21.1831.

  PMID: 9846777 BACKGROUND

• 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. doi: 10.1212/wnl.41.6.799.

  PMID: 2046920 BACKGROUND

• Holland NR. Idiopathic painful sensory neuropathy. J Clin Neuromuscul Dis. 2001 Jun;2(4):211-20. doi: 10.1097/00131402-200106000-00008.

  PMID: 19078638 BACKGROUND

• 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. doi: 10.7547/87507315-92-3-125.

  PMID: 11904323 BACKGROUND

• 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. doi: 10.2337/diacare.27.1.168.

  PMID: 14693984 BACKGROUND

• Mendell JR, Sahenk Z. Clinical practice. Painful sensory neuropathy. N Engl J Med. 2003 Mar 27;348(13):1243-55. doi: 10.1056/NEJMcp022282. No abstract available.

  PMID: 12660389 BACKGROUND

• Prendergast JJ, Miranda G, Sanchez M. Improvement of sensory impairment in patients with peripheral neuropathy. Endocr Pract. 2004 Jan-Feb;10(1):24-30. doi: 10.4158/EP.10.1.24.

  PMID: 15251618 BACKGROUND

• Koltzenburg M. Painful neuropathies. Curr Opin Neurol. 1998 Oct;11(5):515-21. doi: 10.1097/00019052-199810000-00014.

  PMID: 9848001 BACKGROUND

• Wolfe GI, Trivedi JR. Painful peripheral neuropathy and its nonsurgical treatment. Muscle Nerve. 2004 Jul;30(1):3-19. doi: 10.1002/mus.20057.

  PMID: 15221874 BACKGROUND

Related Links

• website of company that provided device to be studied

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Pain

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was terminated early because the study was unable to enroll enough patients.

Results Point of Contact

• Title: Dr. Matthew A. Butters
• Organization: Mayo Clinic

butters.matthew@mayo.edu

480-301-7745

Study Officials

• Matthew A Butters, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2005
• First Posted: July 29, 2005
• Study Start: July 1, 2005
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: September 5, 2012
• Results First Posted: September 5, 2012

Record last verified: 2012-08

Locations

US (1)