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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo laser | Placebo Comparator | inactive laser light |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion of the Neck and Shoulders | one day | |
| Muscle Trigger Points of the Cervical Spine | one day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory C Roche, DO | Principal Investigator | |
| Douglas D Dedo, MD | Principal Investigator | |
| Edward B Lack, MD | Principal Investigator |
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| Label | URL |
|---|---|
| FDA 510(k)#K012580 clearance based on the results of this study | View source |
| FDA 510(k)#K050672 clearance based on this study's results | View source |
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14 enrolled participants were subsequently excluded for taking study excluded medications, for having a self-reported pre-treatment pain Visual Analog Score (VAS) of less than 50 and for having a herniated disc injury.
Recruitment period was June-July, 2001. Locations were 3 private practice test sites: 2 in California and one in Virginia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Laser | inactive laser light |
| FG001 | Erchonia PL2000 | The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Laser | inactive laser light |
| BG001 | Erchonia PL2000 | The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | baseline and one day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Laser | inactive laser light |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elvira Walls, Clinical Consultant | Regulatory Insight, Inc. | 615-712-9743 | elvira@reginsight.com |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D019547 | Neck Pain |
| D059352 | Musculoskeletal Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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|
| Placebo laser | Device | Inactive laser light |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Location of Pain | Pain on the right and/or left sides of the neck and/or shoulders, or both. | Number | participants |
|
| Origin of Pain | Pain originating from one or more of three etiologies: osteoarthritis; muscle spasms, sprain strain. | Number | participants |
|
| Baseline Visual Analog Scale (VAS) pain rating | Participants recorded a self-rating of their degree of pain in the neck-shoulder area before the study treatment was administered on the 0-100 standardized Visual Analog Scale (VAS). The VAS is a 100mm long horizontal line 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 represented the level of pain they experienced at that time in the neck-shoulder area. The higher the number marked, the greater the pain level. | Mean | Standard Deviation | units on a scale |
|
| Duration of Pain | Duration in months of chronic pain in the neck and/or shoulder region. | Mean | Standard Deviation | months |
|
| Erchonia PL2000 |
The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter. |
|
|
|
| Secondary | Range of Motion of the Neck and Shoulders | Not Posted | one day |
| Secondary | Muscle Trigger Points of the Cervical Spine | Not Posted | one day |
| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and one day |
|
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Erchonia PL2000 | The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter. | 0 | 43 | 0 | 43 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |