Clinical trial NCT00929305: Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain
Official title: Study of the Effect of Low Level Laser Therapy on the Reduction of Chronic Pain Associated With Neck and Shoulder Pain of Musculoskeletal Origin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Neck Pain
Musculoskeletal Pain
Musculoskeletal Strain
Musculoskeletal Sprain
Keywords: chronic pain
neck
shoulder
musculoskeletal origin
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 the application of low level laser light therapy to the neck and shoulder region is effective in reducing chronic neck and shoulder pain of musculoskeletal origin.

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:

* Location of pain is on the right and/or left side of the neck and/or shoulder and/or the back of the neck.
* Etiology of pain is osteoarthritis/Degenerative Joint Disorder (DJD); chronic muscle spasms or cervical and thoracic spine sprain strain, determined according to subject medical history, medication use history, previous records review, physical examination of the cervical spine and shoulder.
* Stage of injury is chronic, having prevailed for longer than 30 days.
* Degree of Pain self-rating of 50 or greater on the 0-100 Visual Analog Scale (VAS).
* 18-65 years.

Exclusion Criteria:

* Stage of injury is acute, having prevailed for less than 30 days.
* Known herniated disc injury.
* Any other disease or condition that may cause or contribute to the chronic pain condition.
* Presence of infection or open wound at the treatment areas.
* Use of steroids or narcotics.
* Use of over-the-counter (OTC) medication for the relief of pain within the 24-hour period prior to participating in the treatment phase of the study, or prescription medication for the relief of pain within the 48-hour period prior to participating in the treatment phase of the study.
* pregnant or lactating.

Primary outcomes:
measure: The Number of Participants Whose Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS) Decreased by 30% or More From Baseline to One Day After Study Treatment
timeFrame: baseline and one day
measure: Change in Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS)From Baseline to One Day Post-treatment
timeFrame: baseline and one day
Secondary outcomes:
measure: Range of Motion of the Neck and Shoulders
timeFrame: one day
measure: Muscle Trigger Points of the Cervical Spine
timeFrame: one day
Other outcomes:
Locations:
Study officials:
name: Gregory C Roche, DO
role: PRINCIPAL_INVESTIGATOR
name: Douglas D Dedo, MD
role: PRINCIPAL_INVESTIGATOR
name: Edward B Lack, MD
role: PRINCIPAL_INVESTIGATOR
References: