Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain

Neck Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929305
• Other study ID #: ECP-002
• Status: Completed
• Phase: N/A
• First received: June 25, 2009
• Last updated: April 2, 2014
• Start date: January 2001
• Est. completion date: June 2001

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 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.

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: June 2001
• Est. primary completion date: June 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

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

• Musculoskeletal Pain
• Musculoskeletal Sprain
• Musculoskeletal Strain
• Neck Pain
• Shoulder Pain

Intervention

Device:
• Erchonia PL2000
The Erchonia PL2000 Laser emits 1 mW of red (635nm wavelength) light via an electric diode energy source. 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	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	Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at each point in time. The higher the number marked, the greater the pain level.	baseline and one day	No
Primary	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	Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at that point in time. The higher the number marked, the greater the pain level.	baseline and one day	No
Secondary	Range of Motion of the Neck and Shoulders		one day	No
Secondary	Muscle Trigger Points of the Cervical Spine		one day	No

External Links

•   FDA 510(k)#K012580 clearance based on the results of this study
•   FDA 510(k)#K050672 clearance based on this study's results