Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation
ClinicalTrials.gov Identifier:
NCT00929305
First received: June 25, 2009
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Shoulder Pain
Neck Pain
Musculoskeletal Pain
Musculoskeletal Strain
Musculoskeletal Sprain
Device: Erchonia PL2000
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 Therapy on the Reduction of Chronic Pain Associated With Neck and Shoulder Pain of Musculoskeletal Origin.

Resource links provided by NLM:


Further study details as provided by Erchonia Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Range of Motion of the Neck and Shoulders [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Muscle Trigger Points of the Cervical Spine [ Time Frame: one day ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2001
Study Completion Date: June 2001
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo laser
inactive laser light
Device: Placebo laser
Inactive laser light
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.
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

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:

  • 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.
  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: NCT00929305

Sponsors and Collaborators
Erchonia Corporation
Investigators
Principal Investigator: Gregory C Roche, DO
Principal Investigator: Douglas D Dedo, MD
Principal Investigator: Edward B Lack, MD
  More Information

Additional Information:
No publications provided

Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT00929305     History of Changes
Other Study ID Numbers: ECP-002
Study First Received: June 25, 2009
Results First Received: July 7, 2009
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Erchonia Corporation:
chronic pain
neck
shoulder
musculoskeletal origin

Additional relevant MeSH terms:
Neck Pain
Musculoskeletal Pain
Shoulder Pain
Sprains and Strains
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Arthralgia
Joint Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014