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Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain

Primary Purpose

Shoulder Pain, Neck Pain, Musculoskeletal Pain

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Erchonia PL2000

Placebo laser

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring chronic pain, neck, shoulder, musculoskeletal origin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo laser

Erchonia PL2000

Arm Description

inactive laser light

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Range of Motion of the Neck and Shoulders

Muscle Trigger Points of the Cervical Spine

Full Information

NCT ID

NCT00929305

First Posted

June 25, 2009

Last Updated

April 2, 2014

Sponsor

Erchonia Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00929305

Brief Title

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

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

January 2001 (undefined)

Primary Completion Date

June 2001 (Actual)

Study Completion Date

June 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Erchonia Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Pain, Neck Pain, Musculoskeletal Pain, Musculoskeletal Strain, Musculoskeletal Sprain

Keywords

chronic pain, neck, shoulder, musculoskeletal origin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo laser

Arm Type

Placebo Comparator

Arm Description

inactive laser light

Arm Title

Erchonia PL2000

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Erchonia PL2000

Other Intervention Name(s)

Erchonia PL5000, Erchonia EVRL Laser

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Placebo laser

Intervention Description

Inactive laser light

Primary Outcome Measure Information:

Title

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

Description

Time Frame

baseline and one day

Title

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

Description

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.

Time Frame

baseline and one day

Secondary Outcome Measure Information:

Title

Range of Motion of the Neck and Shoulders

Time Frame

one day

Title

Muscle Trigger Points of the Cervical Spine

Time Frame

one day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregory C Roche, DO

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Douglas D Dedo, MD

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Edward B Lack, MD

Official's Role

Principal Investigator

12. IPD Sharing Statement

Links:

URL

http://www.accessdata.fda.gov/cdrh_docs/pdf/K012580.pdf

Description

FDA 510(k)#K012580 clearance based on the results of this study

URL

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=17825

Description

FDA 510(k)#K050672 clearance based on this study's results

Learn more about this trial

Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain

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