Clinical trial NCT01513148: Effects of Light Emitting Diode Irradiation on the Conduction Parameters of the Superficial Radial Nerve
Official title: The Effect of Light Therapy on Superficial Radial Nerve Conduction Using a Clustered Array of Infrared Super Luminous and Red Light Emitting Diodes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Lead sponsor: Shenandoah University
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The introduction of light emitting diode (LED) devices as a novel treatment for pain relief in place of low-level laser warrants fundamental research on the effect of LED devices on one of the potential explanatory mechanisms: peripheral neurophysiology in vivo. A randomized controlled study will be conducted by measuring nerve conduction on the superficial radial nerve of healthy subjects (n=64). One baseline measurement and five post-irradiation recordings (2-min interval each) will be performed of the nerve conduction velocity (NCV) and peak latency (PL) and peak amplitude (PA). The experimental group (=32) will receive an irradiation of 2 J/cm2 with an infrared LED device (Dynatronics Solaris Model 705), while the placebo group will be treated by sham irradiation. The purpose of this study is to investigate the effects of LED light on the conduction velocity and amplitude of the superficial radial nerve.


Eligibility criteria: Inclusion Criteria:

* no history of neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy

Exclusion Criteria:

* positive findings during the clinical screening examination suggestive of an underlying neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy.
* a history of a neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy.

Primary outcomes:
measure: Nerve Conduction Velocity (Meters Per Second)
timeFrame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment
Secondary outcomes:
measure: Negative Peak Latency (Milliseconds)
timeFrame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment
measure: Temperature (Degrees C)
timeFrame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment
Other outcomes:
Locations:
city: Winchester
country: United States
facility: Shenandoah University Divsion of Physical Therapy
state: Virginia
Study officials:
affiliation: Shenandoah University
name: Todd A Telemeco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greathouse DG, Currier DP, Gilmore RL. Effects of clinical infrared laser on superficial radial nerve conduction. Phys Ther. 1985 Aug;65(8):1184-7. doi: 10.1093/ptj/65.8.1184.
citation: Downie AW, Scott TR. An improved technique for radial nerve conduction studies. J Neurol Neurosurg Psychiatry. 1967 Aug;30(4):332-6. doi: 10.1136/jnnp.30.4.332. No abstract available.
citation: Snyder-Mackler L, Bork CE. Effect of helium-neon laser irradiation on peripheral sensory nerve latency. Phys Ther. 1988 Feb;68(2):223-5. doi: 10.1093/ptj/68.2.223.