A Multicenter, Sham-Controlled, Pilot, Randomized Controlled Trial of Interferential Therapy for the Treatment of
Jenna Clukey1, Joseph Locascio2, Jack Semler3
1Department of Medicine, Division of Gastroenterology, Massachusetts General Hospital.
Goals:
We aimed to evaluate the efficacy and safety of IFT for the treatment of CC in a pilot randomized controlled trial (RCT).
Background:
Subjects with refractory chronic constipation (CC) have limited treatment options. Interferential Therapy (IFT) offers an alternative approach by delivering a therapeutic current to the colon through skin electrodes.
Study:
We performed a multicenter, double-blind, sham-controlled pilot trial (3:1, treatment:sham) of IFT in patients meeting Rome IV criteria for refractory CC, with ≥1 spontaneous bowel movement (SBM)/week and <3 SBMs/week. After a 2-week screening period, participants received either IFT or a sham device, completing treatment for an hour/day for 8 weeks. The sham group then received IFT and the treatment group continued IFT for 8 weeks. Both groups completed a 4-week follow-up without the device.
Results:
We enrolled 17 patients (82% female) at 4 sites, 12 into the treatment group and 5 into sham therapy. There were no significant adverse events. There was no significant difference in the mean number of SBMs/week between groups (3.51 in IFT vs. 2.54 in sham, P=0.35) during the 8-week treatment phase. The IFT device was highly acceptable in this population, with participants willing to pay an average $294±78 out of pocket for the device.
Conclusions:
In this sham-controlled trial of IFT, there was no significant difference in SBM frequency between the treatment and sham groups. On the basis of the feasibility and acceptability of the IFT device, further research into IFT therapy for CC is merited.
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