Low Level Laser Therapy to Reduce Chronic Pain
2. april 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
100
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Erchonia PL2000 Laser
Low level laser light energy comprised of 1 milliWatts (mW) of red light (635 nm).
|
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.
Andre navn:
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Placebo komparator: Placebo laser
inactive light
|
Inactive laser light.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.
Tidsramme: 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.
Tidsramme: 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
|
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Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.
Tidsramme: 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.
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Richard Amy, DC
- Hovedetterforsker: George Gonzalez, DC
- Hovedetterforsker: John Pinto, DC
- Hovedetterforsker: Allen Wentworth, DC
- Hovedetterforsker: Robert Stashko, DC
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2000
Primær fullføring (Faktiske)
1. september 2000
Studiet fullført (Faktiske)
1. september 2000
Datoer for studieregistrering
Først innsendt
25. juni 2009
Først innsendt som oppfylte QC-kriteriene
26. juni 2009
Først lagt ut (Anslag)
29. juni 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
2. mai 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. april 2014
Sist bekreftet
1. april 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ECP-001
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .