Chronic Pain
Conditions
Brief summary
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.
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.
Interventions
DEVICEErchonia PL2000 Laser
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.
DEVICEPlacebo laser
Inactive laser light.
Sponsors
Erchonia Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Muscular-skeletal pain in the neck/shoulder region * Acute and chronic pain in the neck/shoulder region * Restricted range of motion in the neck/shoulder region * Fibrosis or scar tissue in the neck/shoulder region * Inflammation in the neck/shoulder region * Altered function in the neck/shoulder region * Muscle strains in the neck/shoulder region * Rating of 30 or greater on the 0-100 Visual Analog Scale (VAS) pain scale * 18-65 years of age
Exclusion criteria
* Severely herniated disks * Pregnancy * Taken pain medication within the past 12 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | baseline and one hour | 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. |
| Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS) | baseline and one hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment. | baseline and one hour | 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 |
| Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment. | one hour | 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 |
| Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment. | baseline and one hour | 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. |
| Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment. | baseline and one hour | 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. |
Participant flow
Recruitment details
Recruitment period was July through September, 2000 at a single medical clinic.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 . | 50 |
| Placebo Laser inactive light | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Erchonia Low Level Laser Therapy | Placebo Laser | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 100 Participants |
| Duration of Pain | 57.11 months STANDARD_DEVIATION 121.4 | 40.25 months STANDARD_DEVIATION 71.13 | 48.15 months STANDARD_DEVIATION 97.64 |
| Location of Pain Neck | 13 participants | 14 participants | 27 participants |
| Location of Pain Neck & Shoulders | 27 participants | 22 participants | 49 participants |
| Location of Pain Shoulders | 10 participants | 14 participants | 24 participants |
| Pain Rating on the Visual Analog Scale (VAS) | 51.14 units on a scale STANDARD_DEVIATION 16.5 | 49.06 units on a scale STANDARD_DEVIATION 19.48 | 50.10 units on a scale STANDARD_DEVIATION 18 |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Male | 25 Participants | 25 Participants | 50 Participants |
| Type of Pain Acute | 7 participants | 6 participants | 13 participants |
| Type of Pain Chronic | 43 participants | 44 participants | 87 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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.
Time frame: baseline and one hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia PL2000 Laser | Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS) | -27.38 units on a scale | Standard Deviation 19.28 |
| Placebo Laser | Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS) | -2.43 units on a scale | Standard Deviation 12.57 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: baseline and one hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erchonia PL2000 Laser | 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. | 40 participants |
| Placebo Laser | 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. | 7 participants |
p-value: <0.0001Fisher Exact
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
Time frame: one hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia PL2000 Laser | Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment. | 28.00 degrees | Standard Deviation 22.67 |
| Placebo Laser | Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment. | 2.24 degrees | Standard Deviation 0.33 |
p-value: <0.0001t-test, 2 sided
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
Time frame: baseline and one hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia PL2000 Laser | Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment. | 11.28 degrees | Standard Deviation 9.64 |
| Placebo Laser | Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment. | 0.02 degrees | Standard Deviation 6.9 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: baseline and one hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia PL2000 Laser | Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment. | 30.90 degrees | Standard Deviation 25.97 |
| Placebo Laser | Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment. | 1.70 degrees | Standard Deviation 11.6 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: baseline and one hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia PL2000 Laser | Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment. | 11.06 degrees | Standard Deviation 9.63 |
| Placebo Laser | Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment. | 0.72 degrees | Standard Deviation 7.58 |
p-value: <0.0001t-test, 2 sided