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Low Level Laser Therapy to Reduce Chronic Pain

2 april 2014 bijgewerkt door: Erchonia Corporation

Study of the Effect of Low Level Laser Light Therapy on the Reduction of Chronic Pain of the Neck and Shoulders

The purpose of this study was to determine whether low level laser light directed at the neck and shoulders could be effective in the temporary reduction of chronic pain in the neck and shoulder region.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Chronic neck and shoulder pain arising from osteoarthritis, chronic muscle spasms or thoracic or cervical spine sprain strain can be seriously debilitating. Currently available treatment options such as pain relief medication, ice pack, massage, physical therapy and chiropractic are typically of limited effectiveness. More permanent options such as surgery are invasive with long recovery periods and side-effects and complications of their own. Low level laser light therapy, with its proven anti-inflammatory ability, offers a simple non-invasive option for the reduction of chronic neck and shoulder pain.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

100

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Muscular-skeletal pain in the neck/shoulder region
  • Acute and chronic pain in the neck/shoulder region
  • Restricted range of motion in the neck/shoulder region
  • Fibrosis or scar tissue in the neck/shoulder region
  • Inflammation in the neck/shoulder region
  • Altered function in the neck/shoulder region
  • Muscle strains in the neck/shoulder region
  • Rating of 30 or greater on the 0-100 Visual Analog Scale (VAS) pain scale
  • 18-65 years of age

Exclusion Criteria:

  • Severely herniated disks
  • Pregnancy
  • Taken pain medication within the past 12 hours

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Erchonia PL2000 Laser
Low level laser light energy comprised of 1 milliWatts (mW) of red light (635 nm).
Apparaat: Erchonia PL2000 Laser
Low level laser light therapy device that emits 1 mW of red (635 nm wavelength) light. It is a hand-held device that uses rechargeable batteries or a separate power adapter.
Andere namen:
  • Erchonia PL5000
  • Erchonia EVRL-laser
Placebo-vergelijker: Placebo laser
inactive light
Apparaat: Placebo laser
Inactive laser light.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants Whose Self-reported Degree of Pain on the Visual Analog Scale (VAS) in the Neck and Shoulder Area Decreased by 30% or More From Before to After Study Treatment.
Tijdsspanne: baseline and one hour
Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment.
baseline and one hour
Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS)
Tijdsspanne: baseline and one hour
Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment. The change is calculated as the difference from the VAS score recorded at baseline to the VAS score recorded one hour after study treatment administration. A positive change (+) means that the pain got worse and a negative change (-) means that the pain got better.
baseline and one hour

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.
Tijdsspanne: baseline and one hour
Range of motion (ROM) for the left side of the neck is a measure of how well the neck can move to the left side. The participant gently tilts their neck to the left side as far as possible, and this distance is measured in degrees. The change for ROM for the left side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the left side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the left side than before getting the treatment
baseline and one hour
Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment.
Tijdsspanne: one hour
Range of motion (ROM) for the left shoulder is a measure of how well the participant can move the left shoulder. The participant gently raises the left shoulder (and left arm) as far as possible, and this distance is measured in degrees. The change for ROM for the left shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and can move the left shoulder better and further than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the left shoulder can move less easily and not as far than before getting the treatment
one hour
Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.
Tijdsspanne: baseline and one hour
Range of motion (ROM) for the right side of the neck is a measure of how well the neck can move to the right side. The participant gently tilts their neck to the right side as far as possible, and this distance is measured in degrees. The change for ROM for the right side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the right side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the right side than before getting the treatment.
baseline and one hour
Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment.
Tijdsspanne: baseline and one hour
Range of motion (ROM) for the right shoulder is a measure of how well the participant can move the right shoulder. The participant gently raises the right shoulder (with right arm) as far as possible, and this distance is measured in degrees. The change for ROM for the right shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the right shoulder can move further more easily than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the right shoulder can move less and not as far to the left side than before getting the treatment.
baseline and one hour

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Erchonia Corporation

Onderzoekers

  • Hoofdonderzoeker: Richard Amy, DC
  • Hoofdonderzoeker: George Gonzalez, DC
  • Hoofdonderzoeker: John Pinto, DC
  • Hoofdonderzoeker: Allen Wentworth, DC
  • Hoofdonderzoeker: Robert Stashko, DC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2000

Primaire voltooiing (Werkelijk)

1 september 2000

Studie voltooiing (Werkelijk)

1 september 2000

Studieregistratiedata

Eerst ingediend

25 juni 2009

Eerst ingediend dat voldeed aan de QC-criteria

26 juni 2009

Eerst geplaatst (Schatting)

29 juni 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

2 mei 2014

Laatste update ingediend die voldeed aan QC-criteria

2 april 2014

Laatst geverifieerd

1 april 2014

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ECP-001

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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