Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery

• ClinicalTrials.gov Identifier: NCT00926887
• Recruitment Status: Completed
• First Posted: June 24, 2009
• Results First Posted: July 6, 2011
• Last Update Posted: April 17, 2014
• Sponsor: Erchonia Corporation
• Information provided by (Responsible Party): Erchonia Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Device: Erchonia(R) EML Laser; Device: Placebo Laser	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Sham Comparator: Placebo Laser; Placebo Laser is an inactive light	Device: Placebo Laser; Inactive light
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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.'

Secondary Outcome Measures :

1. Swelling Evaluation Through Length by Width Breast Diameter Measurements [ Time Frame: immediately, 24 hours & 7 days post surgery ]
2. Self-reported Degree of Pain Rating in the Breasts Area. [ Time Frame: 24 hours, 7 days, 14 days & 28 days post surgery ]
3. 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.
4. Hydration Level Assessment [ Time Frame: immediately, 24 hours & 7 days post surgery. ]
5. Infection Evaluation [ Time Frame: 24 hours & 7 days post surgery ]
6. Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale [ Time Frame: 7 days post surgery ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Erchonia Corporation

Investigators

• Principal Investigator: Robert F Jackson, MD, FACS
• Principal Investigator: Gregory Roche, DO
• Principal Investigator: Thomas L Jackson, MD

More Information

Additional Information:

FDA 510(k)#K072206 clearance listing resulting from the outcome of this study 

• Responsible Party: Erchonia Corporation
• ClinicalTrials.gov Identifier: NCT00926887
• Other Study ID Numbers: EBA-001
• First Posted: June 24, 2009
• Results First Posted: July 6, 2011
• Last Update Posted: April 17, 2014
• Last Verified: April 2014