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Low Level Laser Therapy to Reduce Chronic Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Erchonia PL2000 Laser
Placebo laser
Sponsored by
Erchonia Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Erchonia PL2000 Laser

    Placebo laser

    Arm Description

    Low level laser light energy comprised of 1 milliWatts (mW) of red light (635 nm).

    inactive light

    Outcomes

    Primary Outcome Measures

    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.
    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)
    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.

    Secondary Outcome Measures

    Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    June 25, 2009
    Last Updated
    April 2, 2014
    Sponsor
    Erchonia Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00929773
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2000 (undefined)
    Primary Completion Date
    September 2000 (Actual)
    Study Completion Date
    September 2000 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Erchonia Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Erchonia PL2000 Laser
    Arm Type
    Active Comparator
    Arm Description
    Low level laser light energy comprised of 1 milliWatts (mW) of red light (635 nm).
    Arm Title
    Placebo laser
    Arm Type
    Placebo Comparator
    Arm Description
    inactive light
    Intervention Type
    Device
    Intervention Name(s)
    Erchonia PL2000 Laser
    Other Intervention Name(s)
    Erchonia PL5000, Erchonia EVRL Laser
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Placebo laser
    Intervention Description
    Inactive laser light.
    Primary Outcome Measure Information:
    Title
    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.
    Description
    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.
    Time Frame
    baseline and one hour
    Title
    Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS)
    Description
    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.
    Time Frame
    baseline and one hour
    Secondary Outcome Measure Information:
    Title
    Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.
    Description
    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
    Time Frame
    baseline and one hour
    Title
    Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment.
    Description
    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
    Time Frame
    one hour
    Title
    Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.
    Description
    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.
    Time Frame
    baseline and one hour
    Title
    Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment.
    Description
    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.
    Time Frame
    baseline and one hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard Amy, DC
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    George Gonzalez, DC
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    John Pinto, DC
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Allen Wentworth, DC
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Robert Stashko, DC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=17825
    Description
    FDA 510(k)#K050672 clearance listing for pain reduction
    URL
    http://www.accessdata.fda.gov/cdrh_docs/pdf/K012580.pdf
    Description
    FDA 510(k)#K012580 clearance based on these study results

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    Low Level Laser Therapy to Reduce Chronic Pain

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