Low Level Laser Therapy to Reduce Chronic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation
ClinicalTrials.gov Identifier:
NCT00929773
First received: June 25, 2009
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Chronic Pain
Device: Erchonia PL2000 Laser
Device: Placebo laser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of the Effect of Low Level Laser Light Therapy on the Reduction of Chronic Pain of the Neck and Shoulders

Resource links provided by NLM:


Further study details as provided by Erchonia Corporation:

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. [ Time Frame: baseline and one hour ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. [ Time Frame: baseline and one hour ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: July 2000
Study Completion Date: September 2000
Primary Completion Date: September 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Erchonia PL2000 Laser
Low level laser light energy comprised of 1 milliWatts (mW) of red light (635 nm).
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
Placebo Comparator: Placebo laser
inactive light
Device: Placebo laser
Inactive laser light.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929773

Sponsors and Collaborators
Erchonia Corporation
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
  More Information

Additional Information:
No publications provided

Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT00929773     History of Changes
Other Study ID Numbers: ECP-001
Study First Received: June 25, 2009
Results First Received: July 6, 2009
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014