Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain

NCT ID: NCT00929305

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2001-06-30

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.

Conditions

Shoulder Pain; Neck Pain; Musculoskeletal Pain; Musculoskeletal Strain; Musculoskeletal Sprain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo laser

inactive laser light

Group Type: PLACEBO_COMPARATOR

Placebo laser

Intervention Type: DEVICE

Inactive laser light

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.

Group Type: ACTIVE_COMPARATOR

Erchonia PL2000

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Placebo laser

Inactive laser light

Intervention Type: DEVICE

Other Intervention Names

Erchonia PL5000; Erchonia EVRL Laser

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erchonia Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory C Roche, DO

Role: PRINCIPAL_INVESTIGATOR

Douglas D Dedo, MD

Role: PRINCIPAL_INVESTIGATOR

Edward B Lack, MD

Role: PRINCIPAL_INVESTIGATOR

Related Links

http://www.accessdata.fda.gov/cdrh_docs/pdf/K012580.pdf

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=17825

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

Other Identifiers

ECP-002

Identifier Type: -

Identifier Source: org_study_id