Low Level Laser Therapy to Reduce Chronic Pain

• 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: Erchonia Corporation
• Information provided by (Responsible Party): Erchonia Corporation

Tracking Information

• First Submitted Date: June 25, 2009
• First Posted Date: June 29, 2009
• Results First Submitted Date: July 6, 2009
• Results First Posted Date: May 2, 2014
• Last Update Posted Date: May 2, 2014
• Study Start Date: July 2000
• Actual Primary Completion Date: September 2000 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: June 26, 2009): Degree of pain in the neck and shoulder region [ Time Frame: one hour ]

Current Secondary Outcome Measures (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 (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: Low Level Laser Therapy to Reduce Chronic Pain
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Chronic Pain

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 26, 2009): 100
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2000
• Actual Primary Completion Date: September 2000 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00929773
• Other Study ID Numbers: ECP-001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Erchonia Corporation
• Study Sponsor: Erchonia Corporation
• Collaborators: Not Provided

Investigators

• 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