TICTOC 1 - Transcutaneous interferrential current to overcome constipation- 1 phyiostherapist clinic based

Children with slow transit constipation treated with transcutaneous electrical stimulation using interferrential current across the abdomen at T9-L2 compared to sham electrical stimulation - change in defecation, soiling, colonic transit and colonic activity.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000418077

Acronym

TICTOC 1

Enrollment

Registered

2010-05-25

Start date

2005-06-20

Completion date

2008-11-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Slow transit constipation (STC) is marked by small soft stools and soiling and is refractory to medical management. Following a pilot study applying transcutaneous electrical stimulation using interferential current (IFC) to STC children, we undertook a randomized controlled trial to determine whether IFC improved colonic function in pediatric STC. Forty-six children (8 -18 years) with confirmed STC were randomly assigned to receive twelve sessions (20 min/session) of active or sham stimulation with IFC over 4 weeks. Two electrodes were placed paraspinally and 2 over the abdomen. Active stimulation was applied by physiotherapists at a comfortable intensity (<40mA, carrier frequency 4kHz, varying beat frequency 80-150Hz). Daily diaries recorded defecation (primary endpoint), soiling, pain and laxative use for 1-month before, during and 2-months after treatment. Quality of life (QOL), colonic transit and 24-hr colonic manometry were compared before and after treatment. Transcutaneous IFC 3-times/week for 1 month increased colonic activity, sped up colonic transit, and improved fecal soiling, abdominal pain, and QOL, in STC children. More frequent stimulation may be required to improve defecation frequency.

Interventions

Transcutaneous electrical stimulation using interferrential current. Applied using 4 electrodes, 2 on the belly at the level of the belly button and 2 on the back. Currents crossed. Stimulation for 20mins, 3 times per week for 4 weeks. Details of electrical stimulation: interferrential current using 4khz carrier frequency, 80-150 hz beat frequency, less than 30mAmps. Intensity turned up until tingling is felt and then turned down to just below sensation.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender

All

Age

8 Years to 18 Years

Healthy volunteers

Inclusion criteria

children with slow transit constipation more than 2 years duration not responding to standard medical therapies

Exclusion criteria

constipation due to anorectal retention or hold up of stool in the anorectum. inability to understand instructions, previous gastrointestinal operations.

Outcome results