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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
25
Compounded topical diclofenac cream applied to the skin three times daily for 10 weeks
Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks
Mayo Clinic
Rochester, Minnesota, United States
Frequency of Breast Pain
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.
Time frame: 4 weeks, 10 weeks
Severity of Breast Pain
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.
Time frame: 4 weeks, 10 weeks
Mean Days of Pain During the 10 Week Treatment Periods
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.
Time frame: Approximately 12 weeks and at 24 weeks after randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.