Near Infrared Light for the Treatment of Painful Peripheral Neuropathy

• Sponsor: Mayo Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00125268
• Collaborator: Anodyne Therapy, LLC (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 57
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Neuropathy	Device: MIRE; Device: Sham Device	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Jul 1, 2005
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: MIRE Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).	Device: MIRE; 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.; Other Names: Anodyne Therapy System
Sham Comparator: Sham 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; The sham device is non-active but otherwise identical to the study device.

Outcome Measures

Primary Outcome Measures

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 [baseline, 4 weeks]

   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

1. 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]

   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.

2. 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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona	Scottsdale	Arizona	United States	85254

Sponsors and Collaborators

• Mayo Clinic
• Anodyne Therapy, LLC

Investigators

• Principal Investigator: Matthew A Butters, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• website of company that provided device to be studied

Publications

• 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.
• 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.
• Holland NR. Idiopathic painful sensory neuropathy. J Clin Neuromuscul Dis. 2001 Jun;2(4):211-20.
• 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.
• Koltzenburg M. Painful neuropathies. Curr Opin Neurol. 1998 Oct;11(5):515-21. Review.
• 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. Clinical practice. Painful sensory neuropathy. N Engl J Med. 2003 Mar 27;348(13):1243-55. Review.
• Prendergast JJ, Miranda G, Sanchez M. Improvement of sensory impairment in patients with peripheral neuropathy. Endocr Pract. 2004 Jan-Feb;10(1):24-30.
• Wolfe GI, Trivedi JR. Painful peripheral neuropathy and its nonsurgical treatment. Muscle Nerve. 2004 Jul;30(1):3-19. Review.

• ClinicalTrials.gov Identifier: NCT00125268
• Other Study ID Numbers: 927-05 00
• First Posted: Jul 29, 2005
• Last Update Posted: Sep 5, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by , ,: painful; peripheral; neuropathy; light; therapy
• Additional relevant MeSH terms: Peripheral Nervous System Diseases

Study Results

Participant Flow

Arm/Group Title	MIRE	Sham
Arm/Group 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.
Period Title: Overall Study
STARTED	16	14
COMPLETED	15	13
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	MIRE	Sham	Total
Arm/Group 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.	Total of all reporting groups
Overall Participants	16	14	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68 (17)	74 (11)	71 (15)
Sex: Female, Male (Count of Participants)
Female	8 50%	4 28.6%	12 40%
Male	8 50%	10 71.4%	18 60%
Region of Enrollment (participants) [Number]
United States	16 100%	14 100%	30 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIRE	Sham
Arm/Group 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.
Measure Participants	0	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIRE	Sham
Arm/Group 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.
Measure Participants	0	0

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIRE	Sham
Arm/Group 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.
Measure Participants	0	0

Adverse Events

Time Frame	Adverse events were collected over the 4 weeks of the study.
Arm/Group Title	MIRE		Sham
Arm/Group 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.
All Cause Mortality
	MIRE		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MIRE		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		1/14 (7.1%)
General disorders
Carcinoma	0/16 (0%)	0	1/14 (7.1%)	1
Other (Not Including Serious) Adverse Events
	MIRE		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		1/14 (7.1%)
General disorders
Hypocalcemia	0/16 (0%)	0	1/14 (7.1%)	1

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.