Low Level Laser Therapy to Reduce Chronic Pain

NCT ID: NCT00929773

Last Updated: 2014-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2000-09-30

Brief Summary

The purpose of this study was to determine whether low level laser light directed at the neck and shoulders could be effective in the temporary reduction of chronic pain in the neck and shoulder region.

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

Chronic Pain

Study Design

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

Study Groups

Erchonia PL2000 Laser

Low level laser light energy comprised of 1 milliWatts (mW) of red light (635 nm).

Group Type: ACTIVE_COMPARATOR

Erchonia PL2000 Laser

Intervention Type: DEVICE

Low level laser light therapy device that emits 1 mW of red (635 nm wavelength) light. It is a hand-held device that uses rechargeable batteries or a separate power adapter.

Placebo laser

inactive light

Group Type: PLACEBO_COMPARATOR

Placebo laser

Intervention Type: DEVICE

Inactive laser light.

Interventions

Erchonia PL2000 Laser

Low level laser light therapy device that emits 1 mW of red (635 nm wavelength) light. 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

• Muscular-skeletal pain in the neck/shoulder region
• Acute and chronic pain in the neck/shoulder region
• Restricted range of motion in the neck/shoulder region
• Fibrosis or scar tissue in the neck/shoulder region
• Inflammation in the neck/shoulder region
• Altered function in the neck/shoulder region
• Muscle strains in the neck/shoulder region
• Rating of 30 or greater on the 0-100 Visual Analog Scale (VAS) pain scale
• 18-65 years of age

Exclusion Criteria

• Severely herniated disks
• Pregnancy
• Taken pain medication within the past 12 hours

• 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

Richard Amy, DC

Role: PRINCIPAL_INVESTIGATOR

George Gonzalez, DC

Role: PRINCIPAL_INVESTIGATOR

John Pinto, DC

Role: PRINCIPAL_INVESTIGATOR

Allen Wentworth, DC

Role: PRINCIPAL_INVESTIGATOR

Robert Stashko, DC

Role: PRINCIPAL_INVESTIGATOR

Related Links

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

FDA 510(k)#K050672 clearance listing for pain reduction

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

FDA 510(k)#K012580 clearance based on these study results

Other Identifiers

ECP-001

Identifier Type: -

Identifier Source: org_study_id