Near Infrared Light for the Treatment of Painful Peripheral Neuropathy

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

MIRE

Sham Device

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring painful, peripheral, neuropathy, light, therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

MIRE

Sham

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

The neuropathic pain scale consists of 10 questions with individual answers rated from 1 to 10, with 0 = no pain to 10 = the most intense pain imaginable. The overall score could range from 0 to 100, with 0 = no pain to 100 = the most intense pain imaginable.

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

The SF-8 Health Survey has 8 questions, each question measuring each of the eight domains of health. Scores are calibrated so that 50 is the average score or norm. A lower score indicates poorer health, and a higher score indicates excellent health.

Full Information

NCT ID

NCT00125268

First Posted

July 27, 2005

Last Updated

August 2, 2012

Sponsor

Mayo Clinic

Collaborators

Anodyne Therapy, LLC

1. Study Identification

Unique Protocol Identification Number

NCT00125268

Brief Title

Near Infrared Light for the Treatment of Painful Peripheral Neuropathy

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Terminated

Why Stopped

Unable to enroll enough patients

Study Start Date

July 2005 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

Collaborators

Anodyne Therapy, LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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 monochromatic near infrared photoenergy therapy (MIRE) in the treatment of pain in axonal peripheral neuropathy. This will be compared with a placebo (sham) device. The MIRE is a FDA approved, drug-free, non-invasive, medical therapeutic device that uses near-infrared light emitting diodes to deliver monochromatic near infrared photoenergy (MIRE) through contact with the skin. The effect of MIRE is believed to increase local blood circulation by dilating vessels and to reduce pain by decreasing local swelling and inflammation. MIRE is also thought to increase local levels of nitric oxide (NO) which may decrease pain levels. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Neuropathy

Keywords

painful, peripheral, neuropathy, light, therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MIRE

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sham

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

MIRE

Other Intervention Name(s)

Anodyne Therapy System

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham Device

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

baseline, 4 weeks

Secondary Outcome Measure Information:

Title

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

Description

The neuropathic pain scale consists of 10 questions with individual answers rated from 1 to 10, with 0 = no pain to 10 = the most intense pain imaginable. The overall score could range from 0 to 100, with 0 = no pain to 100 = the most intense pain imaginable.

Time Frame

baseline, 4 weeks

Title

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

Description

The SF-8 Health Survey has 8 questions, each question measuring each of the eight domains of health. Scores are calibrated so that 50 is the average score or norm. A lower score indicates poorer health, and a higher score indicates excellent health.

Time Frame

baseline, 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew A Butters, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic Arizona

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85254

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

9040716

Citation

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.

Results Reference

background

PubMed Identifier

9846777

Citation

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.

Results Reference

background

PubMed Identifier

2046920

Citation

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.

Results Reference

background

PubMed Identifier

19078638

Citation

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

Results Reference

background

PubMed Identifier

11904323

Citation

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.

Results Reference

background

PubMed Identifier

14693984

Citation

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.

Results Reference

background

PubMed Identifier

12660389

Citation

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.

Results Reference

background

PubMed Identifier

15251618

Citation

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.

Results Reference

background

PubMed Identifier

9848001

Citation

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

Results Reference

background

PubMed Identifier

15221874

Citation

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

Results Reference

background

Links:

URL

http://www.anodynetherapy.com

Description

website of company that provided device to be studied

Peripheral Neuropathy

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial