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Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00929305
First Posted: June 29, 2009
Last Update Posted: April 21, 2014
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.
Information provided by (Responsible Party):
Erchonia Corporation
June 25, 2009
June 29, 2009
July 7, 2009
April 22, 2013
April 21, 2014
January 2001
June 2001   (Final data collection date for primary outcome measure)
  • 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.
Change in self-reported pain rating on the 0-100 VAS [ Time Frame: one day ]
Complete list of historical versions of study NCT00929305 on ClinicalTrials.gov Archive Site
  • Range of Motion of the Neck and Shoulders [ Time Frame: one day ]
  • Muscle Trigger Points of the Cervical Spine [ Time Frame: one day ]
Same as current
Not Provided
Not Provided
 
Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain
Study of the Effect of Low Level Laser Therapy on the Reduction of Chronic Pain Associated With Neck and Shoulder Pain of Musculoskeletal Origin.
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Shoulder Pain
  • Neck Pain
  • Musculoskeletal Pain
  • Musculoskeletal Strain
  • Musculoskeletal Sprain
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2001
June 2001   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00929305
ECP-002
No
Not Provided
Not Provided
Erchonia Corporation
Erchonia Corporation
Not Provided
Principal Investigator: Gregory C Roche, DO
Principal Investigator: Douglas D Dedo, MD
Principal Investigator: Edward B Lack, MD
Erchonia Corporation
April 2014

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