Pain
Conditions
Brief summary
The goal of the clinical study was to see if applying low level laser light therapy to the breasts during breast implant surgery could lessen pain experienced by 24 hours after the surgery.
Detailed description
Substantial pain, discomfort and swelling following breast augmentation surgery is not uncommon. The ability of low level laser therapy to reduce swelling and inflammation that subsequently reduces pain has been well documented. This study aimed to evaluate the ability of low level laser therapy to reduce post-operative pain and swelling for individuals undergoing bilateral breast augmentation surgery, by 24 hours post-surgery.
Interventions
DEVICEErchonia(R) EML Laser
Low level laser red light of 635 nm and delivering 1.5 joules/cm2.
DEVICEPlacebo Laser
Inactive light
Sponsors
Erchonia Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Suitability for breast augmentation surgery based on the need for correction of a congenital deformity or condition such as: Amastia, Hypomastia, Hypoplasia, Pectus Carinatum, Pectus Excavatum, OR a cosmetic breast enhancement indication, including: Augmentation to increase breast size, correction of ptotic (drooping) or pendulous (sagging) breasts, recontouring to obtain enhanced breast shape. * Bilateral breast augmentation indication only. * 18 to 55 years, inclusive. * Female, only. * Willingness, and ability, to refrain from consuming over-the-counter and/or prescription medications for the indication of the relief of pain and/or swelling, including any non-steroidal anit-inflammatory drugs (NSAIDs), from 48 hours immediately prior to the laser-assisted breast implant procedure through to one week post-procedure.
Exclusion criteria
* Breast augmentation procedures indicated for the purpose of breast reconstruction following mastectomy or an injury due to severe trauma. * Presence of a specific connective tissue disorder. * Inadequate tissue available to cover the implants. * Consumption of any one or more of narcotics, opiates, and/or steroids. * Inability to consume the following medications post-operatively due to allergy, intolerance, or any other reason: (i) Pain medication for the relief of post-operative pain of Lortab 10/500 or another drug within the combination narcotic analgesic drug category within which Lortab falls. (ii) Antibiotic medication for reducing the risk of post-operative infection of Keflex 500 mg or Cipro 500 mg or another drug within the broad-spectrum antibiotic drug category within which Keflex and Cipro fall. * Developmental disability or cognitive impairment that impacts a subject's ability to read and/or to understand the content of the informed consent form, and/or impacts a subject's ability to read and /or to understand and/or to complete the required case report form information for the clinical study. * Significant psychological disorder(s) for which treatment has become necessary, including anxiety and depression; psychiatric hospitalization. * Pregnancy or lactation. * Prior surgery to the breast area, or to the area of the intended incision. * Infection or wound in the intended areas of treatment. * Involvement in litigation and/or receiving disability benefits related to the subject's breast(s). * Participation in research over the preceding 90 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative. | 24 hours post-operative | Self-reported Degree of Pain rating using the standardized 0-100 Visual Analog Scale (VAS) scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. The VAS ratings range from 0 to 100, where '0' represents 'no pain at all' and '100' represents 'worst pain imaginable.' A VAS of 30 is indicated as a cutoff threshold for 'success.' Participants who recorded a VAS rating of less than 30 were considered study 'successes' and are reported below. |
| Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative. | 24 hours | Self-reported Degree of Pain rating using the standardized 0-100 VAS scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. VAS values range from '0' representing 'no pain at all' to '100' representing 'worst pain imaginable.' |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of Pain Management Medication Post-surgically. | Through the 1st 7 post-operative days. | Average number of rescue pain medication doses consumed across the 1st 7 post-operative days. |
| Hydration Level Assessment | immediately, 24 hours & 7 days post surgery. | — |
| Swelling Evaluation Through Length by Width Breast Diameter Measurements | immediately, 24 hours & 7 days post surgery | — |
| Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale | 7 days post surgery | — |
| Infection Evaluation | 24 hours & 7 days post surgery | — |
| Self-reported Degree of Pain Rating in the Breasts Area. | 24 hours, 7 days, 14 days & 28 days post surgery | — |
Participant flow
Recruitment details
The recruitment period was from 9/30/05 - 6/28/07 at private practice test site locations.
Pre-assignment details
There were no significant events or approaches for the study following participant enrollment and prior to group assignment. All enrolled participants proceeded to group assignment.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Laser inactive light | 54 |
| Erchonia(R) EML Laser The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2. | 50 |
| Total | 104 |
Baseline characteristics
| Characteristic | Placebo Laser | Erchonia(R) EML 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 | 54 Participants | 50 Participants | 104 Participants |
| Sex: Female, Male Female | 54 Participants | 50 Participants | 104 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 0 / 50 |
| serious Total, serious adverse events | 0 / 54 | 0 / 50 |
Outcome results
Primary
Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative.
Self-reported Degree of Pain rating using the standardized 0-100 Visual Analog Scale (VAS) scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. The VAS ratings range from 0 to 100, where '0' represents 'no pain at all' and '100' represents 'worst pain imaginable.' A VAS of 30 is indicated as a cutoff threshold for 'success.' Participants who recorded a VAS rating of less than 30 were considered study 'successes' and are reported below.
Time frame: 24 hours post-operative
Population: ITT Analysis with LOCF technique employed, as applicable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Laser | Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative. | 20 participants |
| Erchonia(R) EML Laser | Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative. | 37 participants |
p-value: <0.0001Fisher Exact
Primary
Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative.
Self-reported Degree of Pain rating using the standardized 0-100 VAS scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. VAS values range from '0' representing 'no pain at all' to '100' representing 'worst pain imaginable.'
Time frame: 24 hours
Population: Intention to treat (ITT) analysis with imputation technique of Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Laser | Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative. | 36.78 scores on a scale | Standard Deviation 24.62 |
| Erchonia(R) EML Laser | Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative. | 21.40 scores on a scale | Standard Deviation 20.6 |
p-value: <0.001t-test, 2 sided
Secondary
Hydration Level Assessment
Time frame: immediately, 24 hours & 7 days post surgery.
Secondary
Infection Evaluation
Time frame: 24 hours & 7 days post surgery
Secondary
Self-reported Degree of Pain Rating in the Breasts Area.
Time frame: 24 hours, 7 days, 14 days & 28 days post surgery
Secondary
Swelling Evaluation Through Length by Width Breast Diameter Measurements
Time frame: immediately, 24 hours & 7 days post surgery
Secondary
Use of Pain Management Medication Post-surgically.
Average number of rescue pain medication doses consumed across the 1st 7 post-operative days.
Time frame: Through the 1st 7 post-operative days.
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Laser | Use of Pain Management Medication Post-surgically. | 20.26 medication doses | Standard Deviation 8.89 |
| Erchonia(R) EML Laser | Use of Pain Management Medication Post-surgically. | 18.43 medication doses | Standard Deviation 10.03 |
p-value: <0.01t-test, 2 sided
Secondary
Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale
Time frame: 7 days post surgery