NCT01672216.

Trial name or title	Multicentre randomized controlled trial to compare the outcome of conservative triple target treatment with EMG‐biofeedback for chronic constipation (3T‐CO)
Methods	Parallel group randomised multicentre study with blinded observers
Participants	140 Patients > 18 years with chronic constipation (Rome II criteria)
Interventions	Intervention: Stimulation with a carrier wave of 25 KHz and biphasic modulations of the pulse train of 40 KHz ‐ combination of EMG‐biofeeback plus EMG‐triggered AM‐MF stimulation, carried out at home, with an alternating combination in the morning and EMG‐triggered stimulation in the evening for 20 minute periods. Comparison: EMG‐biofeedback alone, carried out at home, standing, mornings and evenings for 20 minute periods.
Outcomes	Primary outcome ‐ Altomare ODS score in its validated form after 3 and 12 months, compared to baseline Secondary outcomes ‐ Constipation Severity Instrument modified Wexner Incontinence Score PAC‐QOL Hinton test Cleveland Clinic Incontinence Score Adapted Vaizey Score International Consultation on Incontinence Questionnaire Short Form (ICIQ‐SF)
Starting date	August 2012
Contact information	Dr T Schwander, University of Giessen, Dept of General Surgery, Giessen, Hessen, Germany 35385
Notes	ongoing, but not recruiting participants ‐ estimated completion May 2015