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The purpose of this study was to determine whether low level laser light directed at the neck and shoulders could be effective in the temporary reduction of chronic pain in the neck and shoulder region.
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 |
|---|---|---|---|
| Erchonia PL2000 Laser | Active Comparator | Low level laser light energy comprised of 1 milliWatts (mW) of red light (635 nm). |
|
| Placebo laser | Placebo Comparator | inactive light |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erchonia PL2000 Laser | Device | Low level laser light therapy device that emits 1 mW of red (635 nm wavelength) light. It is a hand-held device that uses rechargeable batteries or a separate power adapter. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Whose Self-reported Degree of Pain on the Visual Analog Scale (VAS) in the Neck and Shoulder Area Decreased by 30% or More From Before to After Study Treatment. | Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment. | baseline and one hour |
| Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS) | Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment. The change is calculated as the difference from the VAS score recorded at baseline to the VAS score recorded one hour after study treatment administration. A positive change (+) means that the pain got worse and a negative change (-) means that the pain got better. | baseline and one hour |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment. | Range of motion (ROM) for the left side of the neck is a measure of how well the neck can move to the left side. The participant gently tilts their neck to the left side as far as possible, and this distance is measured in degrees. The change for ROM for the left side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the left side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the left side than before getting the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Amy, DC | Principal Investigator | |
| George Gonzalez, DC | Principal Investigator | |
| John Pinto, DC | Principal Investigator | |
| Allen Wentworth, DC | Principal Investigator | |
| Robert Stashko, DC | Principal Investigator |
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| Label | URL |
|---|---|
| FDA 510(k)#K050672 clearance listing for pain reduction | View source |
| FDA 510(k)#K012580 clearance based on these study results | View source |
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Following enrollment and prior to group assignment, study participants underwent study qualification evaluation which included a self-report rating of current neck and/or shoulder pain level on the 0-100 VAS.
Recruitment period was July through September, 2000 at a single medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erchonia PL2000 Laser | Low level laser energy comprised of 1 milliWatt (mW) of near-infrared light (635 nm) to the neck and shoulder area . |
| FG001 | Placebo Laser | inactive light |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Erchonia Low Level Laser Therapy | Low level laser energy comprised of 1 mw of near-infrared light (635 nm) to the neck and shoulder area . |
| BG001 | Placebo Laser | inactive light |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Participants Whose Self-reported Degree of Pain on the Visual Analog Scale (VAS) in the Neck and Shoulder Area Decreased by 30% or More From Before to After Study Treatment. | Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment. | Posted | Number | participants | baseline and one hour |
|
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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 | Erchonia Low Level Laser Therapy | Low level laser energy comprised of 1 mw of near-infrared light (635 nm) to the neck and shoulder area . |
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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 |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo laser | Device | Inactive laser light. |
|
| baseline and one hour |
| Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment. | Range of motion (ROM) for the left shoulder is a measure of how well the participant can move the left shoulder. The participant gently raises the left shoulder (and left arm) as far as possible, and this distance is measured in degrees. The change for ROM for the left shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and can move the left shoulder better and further than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the left shoulder can move less easily and not as far than before getting the treatment | one hour |
| Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment. | Range of motion (ROM) for the right side of the neck is a measure of how well the neck can move to the right side. The participant gently tilts their neck to the right side as far as possible, and this distance is measured in degrees. The change for ROM for the right side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the right side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the right side than before getting the treatment. | baseline and one hour |
| Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment. | Range of motion (ROM) for the right shoulder is a measure of how well the participant can move the right shoulder. The participant gently raises the right shoulder (with right arm) as far as possible, and this distance is measured in degrees. The change for ROM for the right shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the right shoulder can move further more easily than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the right shoulder can move less and not as far to the left side than before getting the treatment. | baseline and one hour |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Location of Pain | Subject report of pain located in the neck, shoulder or both regions. | Number | participants |
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| Type of Pain | Number | participants |
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| Pain Rating on the Visual Analog Scale (VAS) | The Visual Analog Scale (VAS) is used as a self-reported measure of current pain level. Participants mark the spot on the line scale that shows the level of their pain at that time. The scale ranges fron '0: no pain at all' to '100: worst pain imaginable.' The scale is a straight line of 100mm. The point marked by the participant is measured as their current pain level. The higher the number, the greater the pain level. To qualify to be in the study, participants needed to record a Baseline pain level on the VAS of 30 or greater. | Mean | Standard Deviation | units on a scale |
|
| Duration of Pain | Mean | Standard Deviation | months |
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inactive light
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| Secondary | Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment. | Range of motion (ROM) for the left side of the neck is a measure of how well the neck can move to the left side. The participant gently tilts their neck to the left side as far as possible, and this distance is measured in degrees. The change for ROM for the left side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the left side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the left side than before getting the treatment | Posted | Mean | Standard Deviation | degrees | baseline and one hour |
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| Secondary | Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment. | Range of motion (ROM) for the left shoulder is a measure of how well the participant can move the left shoulder. The participant gently raises the left shoulder (and left arm) as far as possible, and this distance is measured in degrees. The change for ROM for the left shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and can move the left shoulder better and further than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the left shoulder can move less easily and not as far than before getting the treatment | Posted | Mean | Standard Deviation | degrees | one hour |
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| Primary | Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS) | Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment. The change is calculated as the difference from the VAS score recorded at baseline to the VAS score recorded one hour after study treatment administration. A positive change (+) means that the pain got worse and a negative change (-) means that the pain got better. | Posted | Mean | Standard Deviation | units on a scale | baseline and one hour |
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| Secondary | Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment. | Range of motion (ROM) for the right side of the neck is a measure of how well the neck can move to the right side. The participant gently tilts their neck to the right side as far as possible, and this distance is measured in degrees. The change for ROM for the right side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the right side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the right side than before getting the treatment. | Posted | Mean | Standard Deviation | degrees | baseline and one hour |
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| Secondary | Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment. | Range of motion (ROM) for the right shoulder is a measure of how well the participant can move the right shoulder. The participant gently raises the right shoulder (with right arm) as far as possible, and this distance is measured in degrees. The change for ROM for the right shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the right shoulder can move further more easily than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the right shoulder can move less and not as far to the left side than before getting the treatment. | Posted | Mean | Standard Deviation | degrees | baseline and one hour |
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| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Placebo Laser | inactive light | 0 | 50 | 0 | 50 |
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