Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000418077
Ethics application status
Approved
Date submitted
21/05/2010
Date registered
25/05/2010
Date last updated
25/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
TICTOC 1 - Transcutaneous interferrential current to overcome constipation- 1 phyiostherapist clinic based
Scientific title
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.
Secondary ID [1] 251851 0
nil
Universal Trial Number (UTN)
U1111-1115-0824
Trial acronym
TICTOC 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children with Slow Transit Constipation: chronic constipation of more than 2 years with no response to standard medical therapies including diet and laxatives. Site of slowing in colonic motility assessed by radionuclear transit study (scintigraphy). Slowing in proximal colon and not at anorectum. 257432 0
Condition category
Condition code
Oral and Gastrointestinal 257578 257578 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256531 0
Treatment: Devices
Comparator / control treatment
Transcutaneous electrical stimulation with no current delivered.
Control group
Placebo

Outcomes
Primary outcome [1] 258499 0
change in number of defecations per week.
Assessed from diary filled in daily by subject or parent. Diary kept for 4 months.
Timepoint [1] 258499 0
1 month before stimulation
1 month of stimulation
1st month after stimulation
2nd month after stimulation

The number of defecations during the month was summed and then divided by number of days/7 to give average number per week during this whole month.
Secondary outcome [1] 264292 0
Change in laxatives use.

Assessed from diary filled in daily by subject or parent. Diary kept for 4 months.
Timepoint [1] 264292 0
1 month before stimulation
1 month of stimulation
1st month after stimulation
1st month after stimulation
2nd month after stimulation

The laxatives taken each day during the month was summed and then divided by number of days/7 to give average number per week during this whole month.
Secondary outcome [2] 264293 0
change in soiling episodes per week

Assessed from diary filled in daily by subject or parent. Diary kept for 4 months.
Timepoint [2] 264293 0
1 month before stimulation
1 month of stimulation
1st month after stimulation
2nd month after stimulation

The number of soiling episodes during the month was summed and then divided by number of days/7 to give average number per week during this whole month.
Secondary outcome [3] 264294 0
Change in abdominal pain

Assessed from diary filled in daily by subject or parent. Diary kept for 4 months.
Timepoint [3] 264294 0
1 month before stimulation
1 month of stimulation
1st month after stimulation
2nd month after stimulation

The number of days with aabdominal pain during the month was summed and then divided by number of days/7 to give average number per week during this whole month.
Secondary outcome [4] 264295 0
change in colonic transit rate (using radioisotope and gamma camera images at 0,2,4,6, 24,30 and 48 hours)

Assessed as geometric centre (GC) of radioactivity at 6, 24, 30 and 48 hours.
Timepoint [4] 264295 0
Two measures
within 12 months before stimulation and
2 months after stimulation
Secondary outcome [5] 264296 0
change in colonic activity (using 24 hour colonic manometry)
Timepoint [5] 264296 0
Two measures:
just before stimulation and
2 months after stimulation

Eligibility
Key inclusion criteria
children with slow transit constipation
more than 2 years duration
not responding to standard medical therapies
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
constipation due to anorectal retention or hold up of stool in the anorectum.
inability to understand instructions,
previous gastrointestinal operations.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children enrolled from surgical and gastroenterology and continence clinics at Royal Childrens Hospital, Melbourne, Australia.
Each child allocated the next study number and a phyisotherapy clinic near their home organised to give the treatment.
2 machines delivered to the therapist: A=active and B= sham (altered to deliver no current). Trial therapist delivers machines and teaches treating clinician how to deliver.
Envelope with treatment code sent to treating physician.
Only the treating physician knows which letter and therefore which machine to use.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using card shuffling performed before enrollment commenced . Randomisation in groups of 6. 6 cardswith 3 labelled A and 3 labelled B were shuffled.

A = active stimulation.
B = sham stimulation.

Then the 3 As and 3 Bs randomised in groups of 6 were placed into envelopes numbered 1-60.

The envelopes were sealed before trial.

As the patients are enrolled they are assigned the next number (trial number 1-60).

the patients are sent to a physiotherapy clinic near their home.
The physiotherapist is sent 2 machines. A = active and B= sham, modified so no current is delivered.

The sealed envelope with the trial number on the outside is mailed to the clinician. they open it to reveal the letter (A or B) to tell them to use an active machine or sham machine.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data entered into the statistical program STATA. Defecation, soiling and abdominal pain analysed in 4 intervals (1 month before, during and 1 and 2 months after stimulation). t-Tests to compare sham and active and ANOVA with Tukey’s post-test for comparing 4 data sets (sham-pre, sham-post, active-pre and active-post). P<0.05 was considered statistically significant. The change (delta) for defecation, soiling and abdominal pain calculated for each patient and compared between the active and sham stimulation groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2005
Actual
20/06/2005
Date of last participant enrolment
Anticipated
Actual
30/11/2008
Date of last data collection
Anticipated
Actual
1/01/2009
Sample size
Target
60
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6981 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 14691 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 257016 0
Government body
Name [1] 257016 0
National Health and Medical Research Council (NHMRC)
Country [1] 257016 0
Australia
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Royal Childrens Hospital,
Royal Parade,
Parkville,
Victoria
3052
Country
Australia
Secondary sponsor category [1] 256276 0
Hospital
Name [1] 256276 0
Royal Childrens Hospital
Address [1] 256276 0
Royal Parade,
Parkville,
Victoria
3052
Country [1] 256276 0
Australia
Secondary sponsor category [2] 256277 0
University
Name [2] 256277 0
Department of Paediatrics, University of Melbourne
Address [2] 256277 0
Royal Childrens Hospital,
Royal Parade,
Parkville,
Victoria
3052
Country [2] 256277 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259035 0
Royal Childrens Hospital Human Research Ethics Committee
Ethics committee address [1] 259035 0
Ethics committee country [1] 259035 0
Australia
Date submitted for ethics approval [1] 259035 0
Approval date [1] 259035 0
24/06/2003
Ethics approval number [1] 259035 0
23040

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31202 0
Dr Bridget Southwell
Address 31202 0
Head of Surgical Research Group, Murdoch Childrens Research Institute, Royal Children's Hospital, Parkville, Melbourne Victoria 3052
Country 31202 0
Australia
Phone 31202 0
+61 3 9345 5069
Fax 31202 0
Email 31202 0
[email protected]
Contact person for public queries
Name 14449 0
Dr Bridget Southwell
Address 14449 0
Head of Surgical Research Group,
Murdoch Childrens Research Institute,
Royal Childrens Hospital,
Parkville, Melbourne
Victoria
3052
Country 14449 0
Australia
Phone 14449 0
61 3 9345 5069
Fax 14449 0
Email 14449 0
[email protected]
Contact person for scientific queries
Name 5377 0
Dr Bridget Southwell
Address 5377 0
Head of Surgical Research Group,
Murdoch Childrens Research Institute,
Royal Childrens Hospital,
Parkville, Melbourne
Victoria
3052
Country 5377 0
Australia
Phone 5377 0
61 3 9345 5069
Fax 5377 0
Email 5377 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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