Effects of Light Emitting Diode Irradiation on the Conduction Parameters of the Superficial Radial Nerve

NCT01513148 | Completed Results

• 1 other identifier: 06-750
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Nerve Conduction Velocity (Meters Per Second)

  Change in nerve conduction velocity (m/s) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = nerve conduction velocity (NCV) - baseline NCV. A positive variance represented an increase from baseline and is interpreted as being an increase or faster velocity.

  pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment

Secondary Outcomes (2)

• Negative Peak Latency (Milliseconds)

  pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment

• Temperature (Degrees C)

  pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment

Study Arms (2)

Superluminous Light Diode Irradiation

EXPERIMENTAL

Application of super luminous diodes light irradiation over the superficial radial nerve

Device: Superluminous light diode

Sham Superluminous Light Diode Irradiation

PLACEBO COMPARATOR

Sham Superluminous Light Diode Irradiation over the Superficial Radial Nerve for the same time period as the intervention group

Device: Superluminous light diode

Interventions

Superluminous light diode DEVICE

900W, 880nm, 1.6 J/cm2 for 30sec

Also known as: Dynatronics Solaris Model 705

Sham Superluminous Light Diode Irradiation; Superluminous Light Diode Irradiation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenandoah University: lead

Study Sites (1)

Shenandoah University Divsion of Physical Therapy

Winchester, Virginia, 22601, United States

Location

Related Publications (3)

• 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.

  PMID: 4023064 BACKGROUND

• 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.

  PMID: 4293407 BACKGROUND

• 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.

  PMID: 3340661 BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

4 subjects were terminated early in the project, two from the light therapy group and two from the sham therapy group. All cases, we were unable to achieve an appropriate baseline temperature of 30 degrees celsius to allow continued participation

Results Point of Contact

• Title: Dr. Todd Telemeco
• Organization: Shenandoah University

ttelemec@su.edu

540-545-7398

Study Officials

• Todd A Telemeco, PhD

  Shenandoah University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 20, 2012
• Study Start: June 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 29, 2013
• Results First Posted: July 4, 2013

Record last verified: 2013-07

Locations

US (1)