Low Level Laser Therapy to Reduce Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Device: Placebo laser; Device: Erchonia PL2000 Laser

• Registration Number: NCT00929773
• Lead Sponsor: Erchonia Corporation

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.

Study Timeline

• Study Start: 2000-07
• Primary Completion: 2000-09
• Study Completion: 2000-09
• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-26
• Study First Posted: 2009-06-29
• Results First Submitted: 2009-07-06
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-02
• Last Update Submitted: 2014-04-02
• Results First Posted: 2014-05-02
• Last Update Posted: 2014-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo laser	Placebo laser	inactive light
Erchonia PL2000 Laser	Erchonia PL2000 Laser	Low level laser light energy comprised of 1 milliWatts (mW) of red light (635 nm).

Primary Outcome Measures

Name	Time	Method
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.	baseline and one hour	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.
Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS)	baseline and one hour	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.

Secondary Outcome Measures

Name	Time	Method
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	Range of motion (ROM) for the left side of the neck is a measure of how well the neck can move to the left side. The participant gently tilts their neck to the left side as far as possible, and this distance is measured in degrees. The change for ROM for the left side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the left side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the left side than before getting the treatment
Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment.	one hour	Range of motion (ROM) for the left shoulder is a measure of how well the participant can move the left shoulder. The participant gently raises the left shoulder (and left arm) as far as possible, and this distance is measured in degrees. The change for ROM for the left shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and can move the left shoulder better and further than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the left shoulder can move less easily and not as far than before getting the treatment
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	Range of motion (ROM) for the right side of the neck is a measure of how well the neck can move to the right side. The participant gently tilts their neck to the right side as far as possible, and this distance is measured in degrees. The change for ROM for the right side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the right side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the right side than before getting the treatment.
Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment.	baseline and one hour	Range of motion (ROM) for the right shoulder is a measure of how well the participant can move the right shoulder. The participant gently raises the right shoulder (with right arm) as far as possible, and this distance is measured in degrees. The change for ROM for the right shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the right shoulder can move further more easily than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the right shoulder can move less and not as far to the left side than before getting the treatment.