Trial Outcomes & Findings for Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery (NCT NCT00926887)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

104 participants

Primary outcome timeframe

24 hours post-operative

Results posted on

2014-04-17

Participant Flow

The recruitment period was from 9/30/05 - 6/28/07 at private practice test site locations.

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.

Participant milestones

Participant milestones
Measure	Placebo Laser inactive light	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.
Overall Study STARTED	54	50
Overall Study COMPLETED	54	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Laser n=54 Participants inactive light	Erchonia(R) EML Laser n=50 Participants 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.	Total n=104 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants	50 Participants n=7 Participants	104 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	50 Participants n=7 Participants	104 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours post-operative

Population: ITT Analysis with LOCF technique employed, as applicable.

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.

Outcome measures

Outcome measures
Measure	Placebo Laser n=54 Participants inactive light	Erchonia(R) EML Laser n=50 Participants 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.
Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative.	20 participants	37 participants

PRIMARY outcome

Timeframe: 24 hours

Population: Intention to treat (ITT) analysis with imputation technique of Last Observation Carried Forward (LOCF).

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.'

Outcome measures

Outcome measures
Measure	Placebo Laser n=54 Participants inactive light	Erchonia(R) EML Laser n=50 Participants 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.
Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative.	36.78 scores on a scale Standard Deviation 24.62	21.40 scores on a scale Standard Deviation 20.60

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Erchonia(R) EML Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elvira Walls, Clinical Consultant

Regulatory Insight, Inc.

Phone: 615-712-9743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place