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Low Level Laser Light Therapy and Chronic Neck and Shoulder 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: NCT00929305
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : April 22, 2013
Last Update Posted : April 21, 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 7, 2009
Results First Posted Date  ICMJE April 22, 2013
Last Update Posted Date April 21, 2014
Study Start Date  ICMJE January 2001
Actual Primary Completion Date June 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
  • The Number of Participants Whose Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS) Decreased by 30% or More From Baseline to One Day After Study Treatment [ Time Frame: baseline and one day ]
    Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at each point in time. The higher the number marked, the greater the pain level.
  • Change in Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS)From Baseline to One Day Post-treatment [ Time Frame: baseline and one day ]
    Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at that point in time. The higher the number marked, the greater the pain level.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2009)
Change in self-reported pain rating on the 0-100 VAS [ Time Frame: one day ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2009)
  • Range of Motion of the Neck and Shoulders [ Time Frame: one day ]
  • Muscle Trigger Points of the Cervical Spine [ Time Frame: one day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain
Official Title  ICMJE Study of the Effect of Low Level Laser Therapy on the Reduction of Chronic Pain Associated With Neck and Shoulder Pain of Musculoskeletal Origin.
Brief Summary The purpose of this study was to determine whether the application of low level laser light therapy to the neck and shoulder region is effective in reducing chronic neck and shoulder pain of musculoskeletal origin.
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
  • Shoulder Pain
  • Neck Pain
  • Musculoskeletal Pain
  • Musculoskeletal Strain
  • Musculoskeletal Sprain
Intervention  ICMJE
  • Device: Erchonia PL2000
    The Erchonia PL2000 Laser emits 1 mW of red (635nm wavelength) light via an electric diode energy source. 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
  • Placebo Comparator: Placebo laser
    inactive laser light
    Intervention: Device: Placebo laser
  • Active Comparator: Erchonia PL2000
    The Erchonia PL2000 Laser emits 1 milliWatt (mW) of red (635nm wavelength) light via an electric diode energy source. It is a hand-held device that uses rechargeable batteries or a separate power adapter.
    Intervention: Device: Erchonia PL2000
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: March 13, 2013)
100
Original Actual Enrollment  ICMJE
 (submitted: June 26, 2009)
86
Actual Study Completion Date  ICMJE June 2001
Actual Primary Completion Date June 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Location of pain is on the right and/or left side of the neck and/or shoulder and/or the back of the neck.
  • Etiology of pain is osteoarthritis/Degenerative Joint Disorder (DJD); chronic muscle spasms or cervical and thoracic spine sprain strain, determined according to subject medical history, medication use history, previous records review, physical examination of the cervical spine and shoulder.
  • Stage of injury is chronic, having prevailed for longer than 30 days.
  • Degree of Pain self-rating of 50 or greater on the 0-100 Visual Analog Scale (VAS).
  • 18-65 years.

Exclusion Criteria:

  • Stage of injury is acute, having prevailed for less than 30 days.
  • Known herniated disc injury.
  • Any other disease or condition that may cause or contribute to the chronic pain condition.
  • Presence of infection or open wound at the treatment areas.
  • Use of steroids or narcotics.
  • Use of over-the-counter (OTC) medication for the relief of pain within the 24-hour period prior to participating in the treatment phase of the study, or prescription medication for the relief of pain within the 48-hour period prior to participating in the treatment phase of the study.
  • pregnant or lactating.
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 NCT00929305
Other Study ID Numbers  ICMJE ECP-002
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: Gregory C Roche, DO
Principal Investigator: Douglas D Dedo, MD
Principal Investigator: Edward B Lack, MD
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