Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain

• 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: Erchonia Corporation
• Information provided by (Responsible Party): Erchonia Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Shoulder Pain; Neck Pain; Musculoskeletal Pain; Musculoskeletal Strain; Musculoskeletal Sprain	Device: Erchonia PL2000; Device: Placebo laser	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, 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.
• Study Start Date: January 2001
• Actual Primary Completion Date: June 2001
• Actual Study Completion Date: June 2001

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. Range of Motion of the Neck and Shoulders [ Time Frame: one day ]
2. Muscle Trigger Points of the Cervical Spine [ Time Frame: one day ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

FDA 510(k)#K012580 clearance based on the results of this study 

FDA 510(k)#K050672 clearance based on this study's results 

• Responsible Party: Erchonia Corporation
• ClinicalTrials.gov Identifier: NCT00929305
• Other Study ID Numbers: ECP-002
• First Posted: June 29, 2009
• Results First Posted: April 22, 2013
• Last Update Posted: April 21, 2014
• Last Verified: April 2014

Keywords provided by Erchonia Corporation:

chronic pain; neck; shoulder; musculoskeletal origin

Additional relevant MeSH terms:

Shoulder Pain; Musculoskeletal Pain; Neck Pain; Pain; Neurologic Manifestations; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases