Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926887
• Other study ID #: EBA-001
• Status: Completed
• Phase: N/A
• First received: June 22, 2009
• Last updated: April 1, 2014
• Start date: September 2005
• Est. completion date: July 2007

Study information

• Verified date: April 2014
• Source: Erchonia Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Erchonia(R) EML Laser
Low level laser red light of 635 nm and delivering 1.5 joules/cm2.
• Placebo Laser
Inactive light

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erchonia Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours post-operative	No
Primary	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.'	24 hours	No
Secondary	Swelling Evaluation Through Length by Width Breast Diameter Measurements		immediately, 24 hours & 7 days post surgery	No
Secondary	Self-reported Degree of Pain Rating in the Breasts Area.		24 hours, 7 days, 14 days & 28 days post surgery	No
Secondary	Use of Pain Management Medication Post-surgically.	Average number of rescue pain medication doses consumed across the 1st 7 post-operative days.	Through the 1st 7 post-operative days.	No
Secondary	Hydration Level Assessment		immediately, 24 hours & 7 days post surgery.	No
Secondary	Infection Evaluation		24 hours & 7 days post surgery	No
Secondary	Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale		7 days post surgery	No

External Links

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