Continuous, low-level, topical heat wrap therapy as compared to acetaminophen for primary dysmenorrhea.
OBJECTIVE
To determine if pain relief provided by a wearable heat wrap (continuous, low-level, topical heat therapy) is superior to oral acetaminophen for primary dysmenorrhea.


METHODS
A randomized, active-controlled, multisite, single-blind (investigator), parallel-design study compared an abdominal wrap to an oral medication (acetaminophen, 1000 mg) over I day. Pain relief (0-5) and abdominal muscle tightness/cramping (0-100) were recorded at 12 time points. At 24 and 48 hours, menstrual symptom-based quality of life was assessed.


RESULTS
Three hundred sixty-seven subjects entered the study, with 344 subjects evaluable. The heat wrap was superior to acetaminophen for pain relief over an 8-hour period (means of 2.48 and 2.17, p = 0.015) and at t hours 3, 4, 5 and 6 (p < or = 0.05). Tightness/cramping was less for the heat wrap versus acetaminophen over 8 hours (means of 40.4 and 44.5, p = 0.04) and at hours 4, 5 and 6 (p < or = 0.05). There was significantly decreased fatigue, fewer mood swings and less lower abdominal cramping (p < or = 0.05) with heat therapy.


CONCLUSIONS
Continuous, low-level, topical heat therapy was superior to acetaminophen for the treatment of dysmenorrhea.
Akin
Mark
M
CEDRA Clinical Research, LLC, Austin, Texas, USA.
Price
William
W
Rodriguez
Gonzalo
G
Erasala
Geetha
G
Hurley
George
G
Smith
Roger P
RP
D000082:Acetaminophen / Q000008:administration & dosage*; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D004412:Dysmenorrhea / Q000188:drug therapy / Q000628:therapy*; D005260:Female; D006358:Hot Temperature / Q000627:therapeutic use*; D006801:Humans; D015999:Multivariate Analysis; D010147:Pain Measurement; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
D018712:Analgesics, Non-Narcotic; D000082:Acetaminophen