None listed
Conditions
Brief summary
This study aims to determine proof-of-principle if a new medical device (rhythm.IC, GI Therapies) is able to improve symptoms of chronic constipation in children. the device delivers painless electrical stimulation across the skin. The new device has been designed using existing devices with additional safety features and better ease of use. The device has not yet been tested on patients. The study does not aim to measure overall effectiveness, but to determine if the new device is able to improve symptoms of chronic constipation in some patients. The primary objective is to determine if stimulation with rhythm.IC can improve constipation symptoms measured with a global measure (Wexner constipation scoring system) after 2 months stimulation.
Interventions
Transcutaneous Electrical Stimulation (TES) will be delivered from the rhythm.IC device, GI Therapies, Melbourne.
electrical stimulation will be applied using sticky electrodes on the skin. Electrodes are applied for the period of stimulation only. There will be four electrodes applied on abdomen and another four on the lower back, held in place by a specially designed belt which also holds the small battery-powered stimulator used to control and deliver the current. The current is first applied
Transcutaneous Electrical Stimulation (TES) will be delivered from the rhythm.IC device, GI Therapies, Melbourne. electrical stimulation will be applied using sticky electrodes on the skin. Electrodes are applied for the period of stimulation only. There will be four electrodes applied on abdomen and another four on the lower back, held in place by a specially designed belt which also holds the small battery-powered stimulator used to control and deliver the current. The current is first applied at the lowest frequency and increased within the specified limits until tingling is felt and then raised until it becomes uncomfortable. The current intensity is then turned down to a comfortable level. This is set as the treatment level and is stored in the device memory. The device automatically ramps up to this level at a comfortable rate when turned on. . Stimulation will be applied at home for 60 min/day for 4 to 8 months. Current will be delivered via two channels, one at 4000 Hz and the other at 4080 to 4160 Hz to create a beat frequency of 80-160 Hz, Current will be delivered at the highest comfortable level for the patient (maximum intensity 40mA). The device records usage (time used in minutes and highest level used and date) and a report can be generated by the clinician showing a calendar with minutes used and highest level each day.
Sponsors
GI therapies Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Patients aged between 4 and 18 with chronic functional idiopathic constipation as defined by a > 6 month history of: *Less than or equal to two “spontaneous complete bowel movement” (SCBM)/week for at least 6 months prior to recruitment and *At least 25% of the time suffer from at least one symptom of: lumpy/hard stools, sensation of incomplete evacuation, need to strain during defaecation, or sensation of anorectal obstruction/blockage.
Exclusion criteria
*Constipation secondary to endocrine causes, metabolic causes or neurological conditions *Known or suspected organic disorders of the large bowel *Serious chronic medical condition *Surgical procedure on the large bowel or rectum *Pregnancy or planning to become pregnant *Insufficient comprehension of English requiring a translator *Implanted cardiac defibrillator or pacemaker
Outcome results
None listed