Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain

NCT00929305 | Completed Results

• 1 other identifier: ECP-002
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Pain; Neck Pain; Musculoskeletal Pain; Musculoskeletal Strain; Musculoskeletal Sprain

Keywords

chronic pain; neck; shoulder; musculoskeletal origin

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Range of Motion of the Neck and Shoulders

  one day

• Muscle Trigger Points of the Cervical Spine

  one day

Study Arms (2)

Placebo laser

PLACEBO COMPARATOR

inactive laser light

Device: Placebo laser

Erchonia PL2000

ACTIVE COMPARATOR

The Erchonia PL2000 Laser emits 1 milliWatt (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.

Device: Erchonia PL2000

Interventions

Erchonia PL2000 DEVICE

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.

Also known as: Erchonia PL5000, Erchonia EVRL Laser

Erchonia PL2000

Placebo laser DEVICE

Inactive laser light

Placebo laser

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erchonia Corporation: lead

Related Links

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

MeSH Terms

Conditions

Shoulder Pain; Neck Pain; Musculoskeletal Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases

Results Point of Contact

• Title: Elvira Walls, Clinical Consultant
• Organization: Regulatory Insight, Inc.

elvira@reginsight.com

615-712-9743

Study Officials

• Gregory C Roche, DO

  PRINCIPAL INVESTIGATOR

• Douglas D Dedo, MD

  PRINCIPAL INVESTIGATOR

• Edward B Lack, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 29, 2009
• Study Start: January 1, 2001
• Primary Completion: June 1, 2001
• Study Completion: June 1, 2001
• Last Updated: April 21, 2014
• Results First Posted: April 22, 2013

Record last verified: 2014-04