Clinical trial NCT00929773: Low Level Laser Therapy to Reduce Chronic Pain
Official title: Study of the Effect of Low Level Laser Light Therapy on the Reduction of Chronic Pain of the Neck and Shoulders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Erchonia Corporation
Sponsor class: INDUSTRY
First posted: 2009-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: baseline and one hour
measure: Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS)
timeFrame: baseline and one hour
Secondary outcomes:
measure: Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.
timeFrame: baseline and one hour
measure: Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment.
timeFrame: one hour
measure: Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.
timeFrame: baseline and one hour
measure: Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment.
timeFrame: baseline and one hour
Other outcomes:
Locations:
Study officials:
name: Richard Amy, DC
role: PRINCIPAL_INVESTIGATOR
name: George Gonzalez, DC
role: PRINCIPAL_INVESTIGATOR
name: John Pinto, DC
role: PRINCIPAL_INVESTIGATOR
name: Allen Wentworth, DC
role: PRINCIPAL_INVESTIGATOR
name: Robert Stashko, DC
role: PRINCIPAL_INVESTIGATOR
References: