Feasibility and preliminary outcomes of spinal magnetic stimulation for functional constipation: a pilot randomized placebo-controlled trial.

PURPOSE: Patients with chronic functional constipation suffer from debilitating symptoms which are unresponsive to conventional treatment options. Spinal magnetic stimulation (SMS) and its extracorporeal stimulation of peripheral nerves offer a potential noninvasive therapeutic option. METHODS: A pilot blinded randomized sham-controlled study was performed. Patients randomized to the treatment SMS-arm underwent daily 60-minute SMS sessions at T9 and L3 spinal processes for 2 weeks. Symptom relief was measured at regular intervals up to 14 weeks after treatment with the use of constipation and quality-of-life questionnaires (Patient Assessment of Constipation Symptoms [PAC-SYM], EuroQOL 5-dimension instrument [EQ-5D], and Hospital Anxiety and Depression Scale [HADS]). RESULTS: From December 2015 to July 2023, 14 patients completed the study (6 in the SMS arm and 8 in the sham arm). Mean age was 55 years (range, 41-70 years), and 12 (85.7%) were male. Median average bowel movements per week and spontaneous bowel movements per week at baseline for the SMS arm was 1.5 and 0.3, respectively, while the sham arm was 4 and 1, respectively. At 14 weeks from start of treatment, SMS arm patients showed a trend in improvement of symptoms in 11 out of 16 questions of PAC-SYM. Average bowel movements per week and EQ-5D health state scores increased from 1.5 to 3 and 50 to 60, respectively. However, these changes did not reach statistical significance. No statistical difference in the symptoms was noted in PAC-SYM (13 questions at weeks 1, 2, 4, 6, 8, 10, 12, and 14), EQ-5D (5 questions at weeks 0, 2, 14), and HADS (14 questions at weeks 0, 2, and 14) questionnaires within both arms. CONCLUSION: The pilot study showed the use of SMS is safe and feasible. While it improved constipation symptoms, the results did not achieve statistical significance possibly related to insufficient participants.