Low Level Laser Therapy to Reduce Chronic Pain

Chronic Pain Clinical Trial

Official title:

Study of the Effect of Low Level Laser Light Therapy on the Reduction of Chronic Pain of the Neck and Shoulders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929773
• Other study ID #: ECP-001
• Status: Completed
• Phase: N/A
• First received: June 25, 2009
• Last updated: April 2, 2014
• Start date: July 2000
• Est. completion date: September 2000

Study information

• Verified date: April 2014
• Source: Erchonia Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2000
• Est. primary completion date: September 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• 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.
• Placebo laser
Inactive laser light.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erchonia Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.	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	baseline and one hour	No
Secondary	Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment.	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	one hour	No
Secondary	Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.	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.	baseline and one hour	No
Secondary	Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment.	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.	baseline and one hour	No

External Links

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