- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00929773
Low Level Laser Therapy to Reduce Chronic Pain
2 april 2014 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
100
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
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.
Andra namn:
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Placebo-jämförare: Placebo laser
inactive light
|
Inactive laser light.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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.
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Richard Amy, DC
- Huvudutredare: George Gonzalez, DC
- Huvudutredare: John Pinto, DC
- Huvudutredare: Allen Wentworth, DC
- Huvudutredare: Robert Stashko, DC
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2000
Primärt slutförande (Faktisk)
1 september 2000
Avslutad studie (Faktisk)
1 september 2000
Studieregistreringsdatum
Först inskickad
25 juni 2009
Först inskickad som uppfyllde QC-kriterierna
26 juni 2009
Första postat (Uppskatta)
29 juni 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
2 maj 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 april 2014
Senast verifierad
1 april 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ECP-001
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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