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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]

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.

Condition category

Condition code

Oral and Gastrointestinal

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]

Treatment: Devices

Comparator / control treatment

Transcutaneous electrical stimulation with no current delivered.

Control group

Placebo

Outcomes

Primary outcome [1]

change in number of defecations per week.
Assessed from diary filled in daily by subject or parent. Diary kept for 4 months.

Timepoint [1]

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]

Change in laxatives use.

Assessed from diary filled in daily by subject or parent. Diary kept for 4 months.

Timepoint [1]

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]

change in soiling episodes per week

Assessed from diary filled in daily by subject or parent. Diary kept for 4 months.

Timepoint [2]

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]

Change in abdominal pain

Assessed from diary filled in daily by subject or parent. Diary kept for 4 months.

Timepoint [3]

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]

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]

Two measures
within 12 months before stimulation and
2 months after stimulation

Secondary outcome [5]

change in colonic activity (using 24 hour colonic manometry)

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Royal Childrens Hospital - Parkville

Recruitment postcode(s) [1]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

Hospital

Name [1]

Royal Childrens Hospital

Address [1]

Royal Parade,
Parkville,
Victoria
3052

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

Department of Paediatrics, University of Melbourne

Address [2]

Royal Childrens Hospital,
Royal Parade,
Parkville,
Victoria
3052

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Childrens Hospital Human Research Ethics Committee

Ethics committee address [1]

Royal Childrens Hospital,
Royal Parade,
Parkville,
Victoria
3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/06/2003

Ethics approval number [1]

23040

Summary

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.

Trial website

Trial related presentations / publications

1.	Chase J, Robertson VJ, Southwell B, Hutson J, Gibb S. Pilot study using transcutaneous electrical stimulation (interferential current) to treat chronic treatment-resistant constipation and soiling in children. J Gastroenterol Hepatol 2005;20:1054-61.

2.	Stanton MP, Hutson JM, Simpson D, Oliver MR, Southwell BR, Dinning P, Cook I, Catto-Smith AG. Colonic manometry via appendicostomy shows reduced frequency, amplitude, and length of propagating sequences in children with slow-transit constipation. J Pediatr Surg 2005;40:1138-45.

3.	Clarke MC, Chow CS, Chase JW, Gibb S, Hutson JM, Southwell BR. Quality of life in children with slow transit constipation. J Pediatr Surg 2008;43:320-4.

4.	King SK, Catto-Smith AG, Stanton MP, Sutcliffe JR, Simpson D, Cook I, Dinning P, Hutson JM, Southwell BR. 24-Hour colonic manometry in pediatric slow transit constipation shows significant reductions in antegrade propagation. Am J Gastroenterol 2008;103:2083-91.

5.	Clarke MC, Chase JW, Gibb S, Catto-Smith AG, Hutson JM, Southwell BR. Standard medical therapies do not alter colonic transit time in children with treatment-resistant slow-transit constipation. Pediatr Surg Int 2009;25:473-478.

6.	Clarke MC, Chase JW, Gibb S, Hutson JM, Southwell BR. Improvement of quality of life in children with slow transit constipation after treatment with transcutaneous electrical stimulation. J Pediatr Surg 2009;44:1268-72; discussion 1272.

7.	Clarke MC, Chase JW, Gibb S, Robertson VJ, Catto-Smith A, Hutson JM, Southwell BR. Decreased colonic transit time after transcutaneous interferential electrical stimulation in children with slow transit constipation. J Pediatr Surg 2009;44:408-12.

8.	Hutson JM, Chase JW, Clarke MC, King SK, Sutcliffe J, Gibb S, Catto-Smith AG, Robertson VJ, Southwell BR. Slow-transit constipation in children: our experience. Pediatr Surg Int 2009;25:403-6.

9.	Ismail KA, Chase J, Gibb S, Clarke M, Catto-Smith AG, Robertson VJ, Hutson JM, Southwell BR. Daily transabdominal electrical stimulation at home increased defecation in children with slow-transit constipation: a pilot study. J Pediatr Surg 2009;44:2388-92.

10. Leong LC, Yik YI, Catto-Smith AG, Robertson VJ, Hutson JM, Southwell BR. Long-term effects of transabdominal electrical stimulation in treating children with slow-transit constipation. J Pediatr Surg. 2011;46(12):2309-12.

Public notes

Contacts

Principal investigator

Name

Dr Bridget Southwell

Address

Head of Surgical Research Group, Murdoch Childrens Research Institute, Royal Children's Hospital, Parkville, Melbourne Victoria 3052

Country

Australia

Phone

+61 3 9345 5069

Fax

bridget.southwell@mcri.edu.au

Contact person for public queries

Name

Dr Bridget Southwell

Address

Head of Surgical Research Group,
Murdoch Childrens Research Institute,
Royal Childrens Hospital,
Parkville, Melbourne
Victoria
3052

Country

Australia

Phone

61 3 9345 5069

Fax

bridget.southwell@mcri.edu.au

Contact person for scientific queries

Name

Dr Bridget Southwell

Address

Head of Surgical Research Group,
Murdoch Childrens Research Institute,
Royal Childrens Hospital,
Parkville, Melbourne
Victoria
3052

Country

Australia

Phone

61 3 9345 5069

Fax

bridget.southwell@mcri.edu.au

No information has been provided regarding IPD availability

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No Supporting Document Provided

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