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Low Level Laser Therapy to Reduce Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00929773
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : May 2, 2014
Last Update Posted : May 2, 2014
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Tracking Information
First Submitted Date  ICMJE June 25, 2009
First Posted Date  ICMJE June 29, 2009
Results First Submitted Date  ICMJE July 6, 2009
Results First Posted Date  ICMJE May 2, 2014
Last Update Posted Date May 2, 2014
Study Start Date  ICMJE July 2000
Actual Primary Completion Date September 2000   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
  • 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. [ Time Frame: 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.
  • Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2009)
Degree of pain in the neck and shoulder region [ Time Frame: one hour ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
  • Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment. [ Time Frame: 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
  • Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment. [ Time Frame: 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
  • Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment. [ Time Frame: 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.
  • Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment. [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2009)
Linear range of motion for the right and left sides of the neck and shoulder [ Time Frame: one hour ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Level Laser Therapy to Reduce Chronic Pain
Official Title  ICMJE Study of the Effect of Low Level Laser Light Therapy on the Reduction of Chronic Pain of the Neck and Shoulders
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Device: 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.
    Other Names:
    • Erchonia PL5000
    • Erchonia EVRL Laser
  • Device: Placebo laser
    Inactive laser light.
Study Arms  ICMJE
  • Active Comparator: Erchonia PL2000 Laser
    Low level laser light energy comprised of 1 milliWatts (mW) of red light (635 nm).
    Intervention: Device: Erchonia PL2000 Laser
  • Placebo Comparator: Placebo laser
    inactive light
    Intervention: Device: Placebo laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2009)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2000
Actual Primary Completion Date September 2000   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00929773
Other Study ID Numbers  ICMJE ECP-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erchonia Corporation
Study Sponsor  ICMJE Erchonia Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Amy, DC
Principal Investigator: George Gonzalez, DC
Principal Investigator: John Pinto, DC
Principal Investigator: Allen Wentworth, DC
Principal Investigator: Robert Stashko, DC
PRS Account Erchonia Corporation
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP