None listed
Conditions
Brief summary
This study aims to study a new management approach for the treatment of severe, longstanding constipation in children. 3-5% of paediatric clinic referrals every year is for the purpose of longstanding constipation. Many children continue to require long term laxatives which can be a difficult to administer and often unpleasant form of treatment. We wish to study the efficacy and safety of small battery powered devices that administer transcutaneous electric stimulation (TES). TES involves the application of gentle pulsatile electric currents on the abdomen with the aim to stimulate improved contraction of the large intestine. We hope to see an improvement in the average number of bowel motions passed per week in the treatment group and hope to bring forth this treatment as one of the many tools available to clinicians to treat severe constipation.
Interventions
Parents of Children in the treatment arm will be trained to use the transcutaneous electrical stimulator at home by clinical staff at point of recruitment at Waikato Hospital clinics.
To deliver current, 4 pads will be applied crossed diagonally from front to back. Interferential treatments delivered a 4- kHz carrier frequency, a beat frequency of 80 to 160 Hz with an intensity of less than 33 mA.
Participants in both arms will be instructed to deliver current, 1 hour daily over a period of
Parents of Children in the treatment arm will be trained to use the transcutaneous electrical stimulator at home by clinical staff at point of recruitment at Waikato Hospital clinics. To deliver current, 4 pads will be applied crossed diagonally from front to back. Interferential treatments delivered a 4- kHz carrier frequency, a beat frequency of 80 to 160 Hz with an intensity of less than 33 mA. Participants in both arms will be instructed to deliver current, 1 hour daily over a period of 6 weeks. Adherence to intervention will be monitored by means of participant diaries where parents will report frequency of device usage and any issues encountered.
Sponsors
Waikato DHB
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
Children between age 5 and 15 referred to Waikato DHB(New Zealand) Paediatric Outpatient Service with Constipation Primary diagnosis of chronic idiopathic constipation (Functional Constipation) by clinician
Exclusion criteria
Patients with an identified organic cause for constipation - namely: Cystic Fibrosis Hirschsprung's disease Spinal Malformations Known anorectal malformations Previous surgery for constipation including appendicostomy but not including manual evacuation Patients with a recent admission for nasogastric washout of constipation within the last 6 weeks Children where cosnsent can't be reasonably obtained
Outcome results
None listed