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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Neck Pain; Shoulder Pain; Musculoskeletal Strain; Musculoskeletal Sprain
• Intervention / Treatment: Device: Placebo laser; Device: Erchonia PL2000

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: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	baseline and one day
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	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.	baseline and one day

Secondary Outcome Measures

Outcome Measure	Time Frame
Range of Motion of the Neck and Shoulders	one day
Muscle Trigger Points of the Cervical Spine	one day

Collaborators and Investigators

• Sponsor: Erchonia Corporation
• Investigators: Principal Investigator: Gregory C Roche, DO; Principal Investigator: Douglas D Dedo, MD; Principal Investigator: Edward B Lack, MD

Publications and helpful links

Helpful Links

• FDA 510(k)#K012580 clearance based on the results of this study
• FDA 510(k)#K050672 clearance based on this study's results

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (Actual): June 1, 2001
• Study Completion (Actual): June 1, 2001

Study Registration Dates

• First Submitted: June 25, 2009
• First Submitted That Met QC Criteria: June 26, 2009
• First Posted (Estimate): June 29, 2009

Study Record Updates

• Last Update Posted (Estimate): April 21, 2014
• Last Update Submitted That Met QC Criteria: April 2, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: chronic pain; neck; shoulder; musculoskeletal origin
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Arthralgia; Neck Pain; Shoulder Pain; Musculoskeletal Pain
• Other Study ID Numbers: ECP-002