Trial Outcomes & Findings for Near Infrared Light for the Treatment of Painful Peripheral Neuropathy (NCT NCT00125268)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

baseline, 4 weeks

Results posted on

2012-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	MIRE Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).	Sham Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
Overall Study STARTED	16	14
Overall Study COMPLETED	15	13
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	MIRE Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).	Sham Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Near Infrared Light for the Treatment of Painful Peripheral Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MIRE n=16 Participants Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).	Sham n=14 Participants Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.	Total n=30 Participants Total of all reporting groups
Age Continuous	68 years STANDARD_DEVIATION 17 • n=5 Participants	74 years STANDARD_DEVIATION 11 • n=7 Participants	71 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	14 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

MIRE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MIRE n=16 participants at risk Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).	Sham n=14 participants at risk Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
General disorders Carcinoma	0.00% 0/16 • Adverse events were collected over the 4 weeks of the study.	7.1% 1/14 • Number of events 1 • Adverse events were collected over the 4 weeks of the study.

Other adverse events

Other adverse events
Measure	MIRE n=16 participants at risk Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).	Sham n=14 participants at risk Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
General disorders Hypocalcemia	0.00% 0/16 • Adverse events were collected over the 4 weeks of the study.	7.1% 1/14 • Number of events 1 • Adverse events were collected over the 4 weeks of the study.

Additional Information

Dr. Matthew A. Butters

Mayo Clinic

Phone: 480-301-7745

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place