Musculoskeletal Pain, Musculoskeletal Sprain, Musculoskeletal Strain, Neck Pain, Shoulder Pain
Conditions
Keywords
chronic pain, neck, shoulder, musculoskeletal origin
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.
Interventions
DEVICEErchonia PL2000
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.
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | baseline and one day | 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 | baseline and one day | 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
| Measure | Time frame |
|---|---|
| Range of Motion of the Neck and Shoulders | one day |
| Muscle Trigger Points of the Cervical Spine | one day |
Participant flow
Recruitment details
Recruitment period was June-July, 2001. Locations were 3 private practice test sites: 2 in California and one in Virginia.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Laser inactive laser light | 43 |
| 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. | 43 |
| Total | 86 |
Baseline characteristics
| Characteristic | Placebo Laser | Erchonia PL2000 | 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 | 43 Participants | 43 Participants | 86 Participants |
| Baseline Visual Analog Scale (VAS) pain rating | 60.00 units on a scale STANDARD_DEVIATION 8.6 | 60.21 units on a scale STANDARD_DEVIATION 9.84 | 60.10 units on a scale STANDARD_DEVIATION 9.19 |
| Duration of Pain | 82.95 months STANDARD_DEVIATION 86.14 | 61.74 months STANDARD_DEVIATION 77.21 | 72.35 months STANDARD_DEVIATION 82.01 |
| Location of Pain Both Neck & Shoulder | 23 participants | 23 participants | 46 participants |
| Location of Pain Neck only | 16 participants | 13 participants | 29 participants |
| Location of Pain Shoulder only | 4 participants | 7 participants | 11 participants |
| Origin of Pain muscle spasms and sprain strain | 26 participants | 31 participants | 57 participants |
| Origin of Pain muscle spasms only | 10 participants | 5 participants | 15 participants |
| Origin of Pain osteoarthritis | 7 participants | 7 participants | 14 participants |
| Sex: Female, Male Female | 23 Participants | 26 Participants | 49 Participants |
| Sex: Female, Male Male | 20 Participants | 17 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 |
Outcome results
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.
Time frame: baseline and one day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Laser | 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 | -4.34 units on a scale | Standard Deviation 14.01 |
| Erchonia PL2000 | 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 | -28.06 units on a scale | Standard Deviation 19.95 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: baseline and one day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Laser | 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 | 5 participants |
| Erchonia PL2000 | 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 | 28 participants |
p-value: <0.0001Fisher Exact
Secondary
Muscle Trigger Points of the Cervical Spine
Time frame: one day
Secondary
Range of Motion of the Neck and Shoulders
Time frame: one day