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Transcutaneous electrical nerve stimulation (TENS) for treatment of constipation in children (Protocol)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
ACKNOWLEDGEMENTS
. . .
REFERENCES . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
SOURCES OF SUPPORT . . . .
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Transcutaneous electrical nerve stimulation (TENS) for treatment of constipation in children (Protocol)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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[Intervention Protocol]
of Paediatrics, University of Malaya, Kuala Lumpur, Malaysia. 2 Department of Paediatrics, Paediatric and Child Health
Research Group, University of Malaya Medical Center, Kuala Lumpur, Malaysia
Contact address: Nai Ming Lai, Department of Paediatrics, Paediatric and Child Health Research Group, University of Malaya Medical
Center, Kuala Lumpur, 50603, Malaysia. lainm@doctors.org.uk. lainm123@yahoo.co.uk.
Editorial group: Cochrane IBD Group.
Publication status and date: New, published in Issue 12, 2013.
Citation: Ng RT, Lai NM, Lee WS, Ang HL, Teo KM. Transcutaneous electrical nerve stimulation (TENS) for treatment of constipation
in children. Cochrane Database of Systematic Reviews 2013, Issue 12. Art. No.: CD010873. DOI: 10.1002/14651858.CD010873.
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
The primary objective is to assess the efficacy and safety of TENS used for the treatment of childhood constipation.
BACKGROUND
Transcutaneous electrical nerve stimulation (TENS) for treatment of constipation in children (Protocol)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
OBJECTIVES
The primary objective is to assess the efficacy and safety of TENS
used for the treatment of childhood constipation.
METHODS
Types of studies
We will include randomised controlled trials and randomised
cross-over studies in which patients have their TENS device turned
off at different periods in the study.
Types of participants
We plan to include studies that enrol children (aged 0 to 18 years)
with a diagnosis of functional constipation with or without accompanying incontinence. We will accept various definitions of
constipation in the included studies, which may be based on diagnosis by a physician or report by patient or caregivers or all three,
or via the use of consensus criteria such as the ROME III criteria for functional gastrointestinal disorders (ROME III). We plan
to exclude studies that assessed patients with constipation due to
secondary causes, such as intestinal obstruction due to structural
lesions, endocrine disorders such as hypothyroidism, metabolic
or neurological problems, neuromuscular disorders, pregnancy or
participants who were on medications that affect gastrointestinal
motility as an adverse effect.
Types of interventions
Studies where a TENS treatment, administered either in clinical
setting or at home, and applied either transabdominally, sacrally
or via other means are compared to no treatment, a sham TENS
treatment, other forms of nerve stimulation or any other pharmaceutical or non-pharmaceutical measures used to treat constipation will be considered for inclusion. We accept all types of devices
used for the purpose of TENS and all dosing regimes (i.e. using
TENS in different intensities such as number of times applied per
day).
Types of outcome measures
Primary outcomes
Transcutaneous electrical nerve stimulation (TENS) for treatment of constipation in children (Protocol)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Secondary outcomes
Electronic searches
The following databases will be searched:
The Cochrane Central Register of Controlled Trials
(CENTRAL, part of The Cochrane Library);
Cochrane Inflammatory Bowel Disease and Functional
Bowel Disorders Group Specialized Trials Register;
MEDLINE (PubMed, National Library of Medicine)
(1950 to present); and
Ovid EMBASE (1980 to present).
We will search MEDLINE (PubMed, National Library of
Medicine) using the following search strategy:
1. Search child*[Title/Abstract]
2. Search Child[MeSH Terms]
3. Search Paediatric[Title/Abstract]
4. Search Adolescent[Title/Abstract]
5. Search Infant*[Title/Abstract]
6. Search Neonat*[Title/Abstract]
7. Search Toddler*[Title/Abstract]
8. Search (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7)
9. Search constipat*[Title/Abstract]
10. Search constipation[MeSH Terms]
11. Search faecal impaction[Title/Abstract]
12. Search impact*[Title/Abstract]
13. Search obstipation[Title/Abstract]
14. Search retent*[Title/Abstract]
15. Search defecat*[Title/Abstract]
16. Search evacuat*[Title/Abstract]
17. Search stool*[Title/Abstract]
18. Search transit[Title/Abstract]
19. Search peristal*[Title/Abstract]
20. Search motility[Title/Abstract]
21. Search activit*[Title/Abstract]
22. Search incomplete evaluation[Title/Abstract]
23. Search strain*[Title/Abstract]
24. Search (#9 OR #10 OR #11 OR #12 OR #13 OR #14 OR
#15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #
22 OR #23)
25. Search bowel[Title/Abstract]
26. Search abdom*[Title/Abstract]
27. Search (#25 OR #26)
28. Search function*[Title/Abstract]
29. Search habit*[Title/Abstract]
30. Search movement*[Title/Abstract]
31. Search symptom*[Title/Abstract]
32. Search motion* [Title/Abstract]
33. Search (#28 OR #29 OR #30 OR #31 OR #32)
34. Search #27 AND #33
35. Search #24 OR #34
36. Search nerve stimulat*[Title/Abstract]
37. Search electro-acupuncture[Title/Abstract]
38. Search electroacupuncture[Title/Abstract]
39. Search neuro-modulation[Title/Abstract]
40. Search neuromodulation [Title/Abstract]
41. Search trans-abdominal stimulat*[Title/Abstract]
42. Search sacral nerve stimulat*[Title/Abstract]
43. Search transcutaneous electr* stimulat*[Title/Abstract]
44. Search interferential electr* stimulat*[Title/Abstract]
45. Search medtronic[Title/Abstract]
46. Search SXDZ-100[Title/Abstract]
47. Search SDZ-II[Title/Abstract]
48. Search ST 25[Title/Abstract]
49. Search TE 6[Title/Abstract]
50. Search ST 36[Title/Abstract]
51. Search ST 37[Title/Abstract]
52. Search (#36 OR #37 OR #38 OR #39 OR #40 OR #41
OR #42 OR #43 OR #44 OR #45 OR #46 OR #47 OR #48
Transcutaneous electrical nerve stimulation (TENS) for treatment of constipation in children (Protocol)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Selection of studies
Transcutaneous electrical nerve stimulation (TENS) for treatment of constipation in children (Protocol)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Assessment of heterogeneity
We will inspect the forest plots to globally assess the variation in
the treatment effects of individual trials. We will then assess the
included studies in terms of similarity of population, intervention, outcome and follow-up. We will consider populations to be
similar when they are of similar age range and underlying pathology leading to constipation. We will consider interventions to be
similar when they involve nerve stimulation through the skin. We
will consider all outcomes that measure the same construct to be
similar. For example, the number of bowel motions over a period
of time or the amount of stool passed. However, we will regard objective measurement of outcomes such as the frequency of bowel
movements and subjective report of outcomes such as the ease of
bowel movements to be different. We will consider regard followup times of up to one month as short-term, one to six months as
medium-term and more than six months as long-term. We will
only pool data in a meta-analysis if studies are similar in terms
of population, intervention, outcome and follow-up (to be determined by consensus). In cases where there are some differences
among the studies and we are unsure of the significance of these
differences, we will perform a sensitivity analyses to assess the impact of including and excluding these studies.
We plan to use the Chi2 test and the I2 statistic to evaluate statistical heterogeneity. If the Chi2 test shows statistically significant
heterogeneity, as indicated by a P value of less than 0.1, we will
quantify the degree of heterogeneity using the I2 statistic. In this
review, we define an I2 statistic of 50% or higher as substantial
heterogeneity. In such cases, we will explore possible causes for the
heterogeneity by prespecified subgroup analyses. If the degree of
heterogeneity is excessive, as indicated by an I2 statistic of more
than 75% which is not contributed predominantly by a single
study, we will consider not pooling the studies for meta-analysis
Transcutaneous electrical nerve stimulation (TENS) for treatment of constipation in children (Protocol)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
outcomes are missing, we will search for the study protocol, either
from PubMed, the relevant trial registry, the web link provided by
the study or directly from the study authors, to establish whether
these outcomes were prespecified.
Where possible, a sensitivity analysis will be performed to explore
the impact of excluding studies with a high risk of reporting bias.
Assessment of publication bias
We plan to screen for publication bias by using a funnel plot if
there are a sufficient number of studies (at least 10) included in the
analysis. If publication bias is suspected as indicated by significant
asymmetry of the funnel plot, we will include a statement in our
results and the summary of findings table with a corresponding
note of caution in the discussion.
Data synthesis
For dichotomous outcomes we will calculate the pooled RR and
corresponding 95% CI. In the case of statistically significant results, we will calculate the pooled risk difference (RD) and 95% CI
and the number needed to treat for an additional beneficial outcome (NNTB) or for an additional harmful outcome (NNTH) as
appropriate. For continuous outcomes we will calculate the pooled
MD or SMD and corresponding 95% CI as appropriate. We plan
to use a fixed-effect model to pool data. A random-effects model
will be used when significant heterogeneity is identified. If possible, we will analyse all data on an Intention-to-treat basis. We
will provide a narrative description of any skewed data reported as
medians and interquartile ranges.
Sensitivity analysis
We will perform sensitivity analysis defined a priori to assess the
robustness of our conclusions. Potential sensitivity analyses will
include the following.
1. Fixed-effect versus random-effects models.
2. Excluding studies judged to be at high risk of selection bias.
3. Excluding studies judged to be at high risk of attrition bias.
4. Excluding studies judged to be ay high risk of performance or
detection bias.
5. Excluding studies judged to be at high risk of reporting bias.
6. Excluding cross-over studies and studies with multiple enrolment of the same participants .
ACKNOWLEDGEMENTS
Funding for the IBD/FBD Review Group (September 1, 2010 August 31, 2015) has been provided by the Canadian Institutes of
Health Research (CIHR) Knowledge Translation Branch (CON
- 105529) and the CIHR Institutes of Nutrition, Metabolism
and Diabetes (INMD); and Infection and Immunity (III) and the
Ontario Ministry of Health and Long Term Care (HLTC3968FL2010-2235).
The authors would like to acknowledge the editors and peer reviewers for their comments on the draft protocol.
Miss Ila Stewart has provided support for the IBD/FBD Review
Group through the Olive Stewart Fund.
Transcutaneous electrical nerve stimulation (TENS) for treatment of constipation in children (Protocol)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
REFERENCES
Additional references
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Aboumarzouk OM, Agarwal T, Antakia R, Shariff U,
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Chase J, Robertson V J, Southwell B, Hutson J, Gibb S.
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Clarke MC, Catto-Smith AG, King SK, Dinning PG, Cook
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Ismail KA, Chase J, Gibb S, Clarke M, Catto-Smith AG,
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Transcutaneous electrical nerve stimulation (TENS) for treatment of constipation in children (Protocol)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Mulvey 2010
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Transcutaneous electrical nerve stimulation (TENS) for treatment of constipation in children (Protocol)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
CONTRIBUTIONS OF AUTHORS
WSL and NML conceived the review.
NML and RTN drafted the search strategy.
RTN, NML, KMT, HLA and WSL wrote and revised the protocol.
DECLARATIONS OF INTEREST
None known.
SOURCES OF SUPPORT
Internal sources
University of Malaya Paediatric and Child Health Research Group, Malaysia.
External sources
No sources of support supplied
Transcutaneous electrical nerve stimulation (TENS) for treatment of constipation in children (Protocol)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.