Peripheral NeuropathyNCT01513148

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

A study testing Superluminous light diode in people with Peripheral Neuropathy, run by Shenandoah University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Peripheral Neuropathy
What is being tested?: Superluminous light diode
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteUnited States
Study dates: Jun 2006to Sep 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Shenandoah University Divsion of Physical Therapy
Winchester, Virginia, 22601

Other trials in United States

About this study

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

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
Being tested: Superluminous light diode
Medical subject headings: Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Superluminous light diodeDevice
Also called Dynatronics Solaris Model 705
900W, 880nm, 1.6 J/cm2 for 30sec

Study groups in NCT01513148
Study group	Role	What they receive
Superluminous Light Diode Irradiation	Experimental	Application of super luminous diodes light irradiation over the superficial radial nerve Receives: 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 Receives: Device: Superluminous light diode

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Negative Peak Latency (Milliseconds)
Change in negative peak latency (ms) 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 period = negative peak latency NPL - baseline NPL. A positive variance can be interpreted as being increase from baseline or a prolonged or slowed NPL.
Measured: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment
Temperature (Degrees C)
Change in superficial skin temperature (degrees C) 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 = Temperature - Temperature at baseline. A positive variance int his calculation can be interpreted as being an increase from baseline or an increase in skin temperature
Measured: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Sep 2008

First posted20 Jan 2012 (estimated)
Study startJun 2006
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01513148
Sponsor's protocol ID: 06-750
Status last verified: Jul 2013
First submitted: 9 Jan 2012
Last updated: 29 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 4023064
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.
PubMed 4293407
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.
PubMed 3340661

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01513148
Acronym / sponsor ID: 06-750
Conditions: Peripheral Neuropathy
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Shenandoah UniversityUniversity, hospital or other
Study start: Jun 2006
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 20 Jan 2012 (estimated)
Results: Posted 4 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Superluminous Light Diode Irradiation	Experimental	Device: Superluminous light diodeApplication of super luminous diodes light irradiation over the superficial radial nerve
Sham Superluminous Light Diode Irradiation	Placebo comparator	Device: Superluminous light diodeSham Superluminous Light Diode Irradiation over the Superficial Radial Nerve for the same time period as the intervention group

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Superluminous light diodeAlso: Dynatronics Solaris Model 705900W, 880nm, 1.6 J/cm2 for 30sec	Device	Sham Superluminous Light Diode Irradiation, Superluminous Light Diode Irradiation

Primary outcome

Nerve Conduction Velocity (Meters Per Second)
Time frame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment
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.

2 secondary outcomes

Negative Peak Latency (Milliseconds)
Time frame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment
Temperature (Degrees C)
Time frame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment

Results and safety

Results posted to the registry on 4 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Light Therapy	16	14
Sham Irradiation	16	14

Primary outcome: Nerve Conduction Velocity (Meters Per Second)

Time frame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment. Mean (Standard Deviation). Unit: m/s

Measure	Light NCV Pretreatment n = 14	Light NCV Time 0 n = 14	Light NCV Time 2 n = 14	Light NCV Time 4 n = 14	Light NCV Time 6 n = 14	Light NCV Time 8 n = 14	Light NCV Time 10 n = 14	Sham NCV Pretreatment n = 14	Sham NCV Time 0 n = 14	Sham NCV Time 2 n = 14	Sham NCV Time 4 n = 14	Sham NCV Time 6 n = 14	Sham NCV Time 8 n = 14	Sham NCV Time 10 n = 14
Value	0.000 (0.000)	-0.358 (1.200)	0.447 (1.616)	0.147 (1.785)	-0.041 (1.741)	0.280 (1.801)	0.100 (2.117)	0.000 (0.000)	0.151 (1.251)	-0.004 (1.386)	0.447 (1.616)	1.116 (1.530)	0.521 (1.652)	0.675 (2.012)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Light Therapy	0 of 16 (0%)	0 of 16 (0%)	Not reported
Sham Irradiation	0 of 16 (0%)	0 of 16 (0%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 4023064Greathouse 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.
Background: PubMed 4293407Downie 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.
Background: PubMed 3340661Snyder-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.

Related trials for Peripheral Neuropathy

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Todd A Telemeco, PhD principal investigator

Shenandoah University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Superluminous light diode in people with Peripheral Neuropathy, run by Shenandoah University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nerve Conduction Velocity (Meters Per Second) (time frame: pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01513148, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2013.