Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation
ClinicalTrials.gov Identifier:
NCT00926887
First received: June 22, 2009
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention
Pain
Device: Erchonia(R) EML Laser
Device: Placebo Laser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Erchonia Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Swelling Evaluation Through Length by Width Breast Diameter Measurements [ Time Frame: immediately, 24 hours & 7 days post surgery ] [ Designated as safety issue: No ]
  • Self-reported Degree of Pain Rating in the Breasts Area. [ Time Frame: 24 hours, 7 days, 14 days & 28 days post surgery ] [ Designated as safety issue: No ]
  • Use of Pain Management Medication Post-surgically. [ Time Frame: Through the 1st 7 post-operative days. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • Infection Evaluation [ Time Frame: 24 hours & 7 days post surgery ] [ Designated as safety issue: No ]
  • Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale [ Time Frame: 7 days post surgery ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: September 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926887

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:
No publications provided

Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT00926887     History of Changes
Other Study ID Numbers: EBA-001
Study First Received: June 22, 2009
Results First Received: June 26, 2009
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014