Low Level Laser Therapy to Reduce Chronic Pain

NCT00929773 | Completed Results

• 1 other identifier: ECP-001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Number of Participants Whose Self-reported Degree of Pain on the Visual Analog Scale (VAS) in the Neck and Shoulder Area Decreased by 30% or More From Before to After Study Treatment.

  Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment.

  baseline and one hour

• Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS)

  Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment. The change is calculated as the difference from the VAS score recorded at baseline to the VAS score recorded one hour after study treatment administration. A positive change (+) means that the pain got worse and a negative change (-) means that the pain got better.

  baseline and one hour

Secondary Outcomes (4)

• Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.

  baseline and one hour

• Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment.

  one hour

• Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.

  baseline and one hour

• Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment.

  baseline and one hour

Study Arms (2)

Erchonia PL2000 Laser

ACTIVE COMPARATOR

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

Device: Erchonia PL2000 Laser

Placebo laser

PLACEBO COMPARATOR

inactive light

Device: Placebo laser

Interventions

Erchonia PL2000 Laser 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.

Also known as: Erchonia PL5000, Erchonia EVRL Laser

Erchonia PL2000 Laser

Placebo laser DEVICE

Inactive laser light.

Placebo laser

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age

You may not qualify if:

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

Sponsors & Collaborators

• Erchonia Corporation: lead

Related Links

• FDA 510(k)#K050672 clearance listing for pain reduction
• FDA 510(k)#K012580 clearance based on these study results

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Elvira Walls, Clinical Consultant
• Organization: Regulatory Insight, Inc.

elvira@reginsight.com

615-712-9743

Study Officials

• Richard Amy, DC

  PRINCIPAL INVESTIGATOR

• George Gonzalez, DC

  PRINCIPAL INVESTIGATOR

• John Pinto, DC

  PRINCIPAL INVESTIGATOR

• Allen Wentworth, DC

  PRINCIPAL INVESTIGATOR

• Robert Stashko, DC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 29, 2009
• Study Start: July 1, 2000
• Primary Completion: September 1, 2000
• Study Completion: September 1, 2000
• Last Updated: May 2, 2014
• Results First Posted: May 2, 2014

Record last verified: 2014-04