Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery
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|ClinicalTrials.gov Identifier: NCT00926887|
Recruitment Status : Completed
First Posted : June 24, 2009
Results First Posted : July 6, 2011
Last Update Posted : April 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pain||Device: Erchonia(R) EML Laser Device: Placebo Laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled Evaluation of the Effect of the Erchonia(R) EML Laser on Reducing Pain Following Breast Augmentation Surgery|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
Sham Comparator: Placebo Laser
Placebo Laser is an inactive light
Device: Placebo Laser
Active Comparator: Erchonia EML 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.
- Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative. [ Time Frame: 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. [ Time Frame: 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.'
- 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. [ Time Frame: 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 [ 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926887
|Principal Investigator:||Robert F Jackson, MD, FACS|
|Principal Investigator:||Gregory Roche, DO|
|Principal Investigator:||Thomas L Jackson, MD|