An interventional study of Erchonia(R) EML Laser and Placebo Laser in Pain, sponsored by Erchonia Corporation. Completed. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-17.
Sponsored by Erchonia Corporation · Not applicable, Interventional, and Treatment
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.
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.
Erchonia Corporation is the lead sponsor of 48 studies on the registry; 2 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Placebo Laser is an inactive light
Device: Placebo Laser
Erchonia EML Laser uses two 7mW red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
Device: Erchonia(R) EML Laser
Low level laser red light of 635 nm and delivering 1.5 joules/cm2.
Inactive light
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
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
Swelling Evaluation Through Length by Width Breast Diameter Measurements
Time frame: immediately, 24 hours & 7 days post surgery
Self-reported Degree of Pain Rating in the Breasts Area.
Time frame: 24 hours, 7 days, 14 days & 28 days post surgery
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.
Hydration Level Assessment
Time frame: immediately, 24 hours & 7 days post surgery.
Infection Evaluation
Time frame: 24 hours & 7 days post surgery
Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale
Time frame: 7 days post surgery
The recruitment period was from 9/30/05 - 6/28/07 at private practice test site locations.
| Milestone | Placebo Laser | Erchonia(R) EML Laser |
|---|---|---|
| Started | 54 | 50 |
| Completed | 54 | 50 |
| Not completed | 0 | 0 |
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.
| participants | Placebo Laser | 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. | 20 | 37 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Average number of rescue pain medication doses consumed across the 1st 7 post-operative days.
| medication doses | Placebo Laser | Erchonia(R) EML Laser |
|---|---|---|
| Use of Pain Management Medication Post-surgically. | 20.26 ± 8.89 | 18.43 ± 10.03 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
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.'
| scores on a scale | Placebo Laser | Erchonia(R) EML Laser |
|---|---|---|
| Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative. | 36.78 ± 24.62 | 21.40 ± 20.60 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Laser | — | 0/54 (0%) | 0/54 (0%) |
| Erchonia(R) EML Laser | — | 0/50 (0%) | 0/50 (0%) |
| Age, Categorical(Participants) | Placebo Laser | Erchonia(R) EML Laser | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 54 | 50 | 104 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Placebo Laser | Erchonia(R) EML Laser | Total |
|---|---|---|---|
| Female | 54 | 50 | 104 |
| Male | 0 | 0 | 0 |
No study locations are listed for this record.
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Erchonia Corporation