Clinical Trial: Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Topical Diclofenac for the Treatment of Noncyclic Breast Pain

Brief Summary: The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain.

Detailed Summary: A prospective, randomized, double-blinded crossover trial comparing topical diclofenac and placebo for 10 weeks in the treatment of 30 women with noncyclic mastalgia and surgical scar-related breast pain.
Sponsor: Mayo Clinic

Current Primary Outcome:

  • Frequency of Breast Pain [ Time Frame: 4 weeks, 10 weeks ]
    Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. The frequency of breast pain will be determined by the number of days per week that the subject recorded experiencing pain at 4 weeks and 10 weeks of each treatment.
  • Severity of Breast Pain [ Time Frame: 4 weeks, 10 weeks ]
    Severity will measured using a 100 mm visual analog scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain severity VAS, 0 means no pain and 100 means extreme pain. The investigator measures the written mark of the participant in mm, and records this for the value of pain severity. The severity of breast pain will be determined by the mean of breast pain scores (determined for all days and for days for which pain is greater than 0) at 4 weeks and 10 weeks of each treatment.


Original Primary Outcome:

  • Frequency of Breast Pain
  • Severity of Breast Pain


Current Secondary Outcome: Mean Days of Pain During the 10 Week Treatment Periods [ Time Frame: Approximately 12 weeks and at 24 weeks after randomization ]

Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. Mean number of days with pain during each 10 week treatment period will be calculated.


Original Secondary Outcome:

  • Side effects
  • Adherence
  • Level of anxiety generated by breast symptoms


Information By: Mayo Clinic

Dates:
Date Received: January 11, 2006
Date Started: June 2005
Date Completion:
Last Updated: December 13, 2012
Last Verified: December 2012