Pulsed Heat as a Drug-free Treatment for Pregnancy Related Pain

Studies indicate that up to 75% of women will experience pain sometime during their pregnancy. Recent recommendations by the FDA recommended that non-steroidal anti-inflammatory (NSAIDS) medications be avoided during pregnancy. This recommendation limits the pain medications available for use during pregnancy.Antidotal evidence suggests that the FDA cleared Soovu pulsed heat device may produce pain relief during pregnancy. This study tests the Soovu device's ability to provide pain relief during pregnancy and up to one month post-partum and may eventually offer a safe nondrug option to treat pregnancy related pain.This is an observational pilot studyThe primary objective and hypothesis of this study is that the use of the Soovu pain management device will produce a significant reduction of pain when comparing pre versus post treatment pain.

Inclusion Criteria:Pregnant subjects in the second and third trimester of pregnancy with pain related to their pregnancy.Subjects must have a pain level greater then 4 on a 0-10 point numeric pain scale.Subjects between the ages of 18 and 60 years old.Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.Exclusion Criteria:Subjects felt to have any condition or complication related to their pregnancy that their provider recommends that the subject abstains from the use of the Soovu device.Subjects with a BMI > 0.45Subjects who have a significant ongoing pain problem unrelated to their pregnancy that would make interpretation of their study data uncertain.Presence of a condition or abnormality that in the opinion of the investigator or provider would compromise the safety of the patient or the quality of the data.