Protocol summary
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Study aim
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To compare the effects of neuromodulation (transcutaneous tibial nerve stimulation(TTNS)) with manometric biofeedback on physiologial and clinical factors in female with functional constipation
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Design
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This will be a clinical trial including two interventional groups.Thereafter, the results will be compared in the groups. Based on previous studies, the sample size will be 15 patients per group (total 30). Patients will randomly be allocated in either biofeedback or TTNS
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Settings and conduct
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This study will be performed at the Shariati Hospital's Digestive Disease Research Institute and patients will receive consent form when they will be screened and examined by a gastroenterologist if they meet the inclusion criteria.
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Participants/Inclusion and exclusion criteria
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Female with functional constipation aged between 25 – 60 years, Definition of constipation based on Rome III criteria, No history of previous large-bowel surgery or cancer, Pregnant patient exclude from study
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Intervention groups
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In this study patients with functional constipation are examined by colorectal specialist, then Para clinical tests including: anorectal manometry,BET and CTT study, are performed for them. Baseline evaluation include patient completion of the SF36 QOL and the Wexner questionnaire, food and stool diary for three weeks. Nutritional advices, proper defecation technique, diaphragmatic breathing technique, physical activity and massage are trained for three weeks also. After one month, based on inclusion criteria, they will randomly assign to biofeedback or TTNS group.
Intervention in the biofeedback group will be given for 5 sessions once a week, and in the TTNS group, 12 sessions, three times a week
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Main outcome variables
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Wexner and SF36 QOL questionnaire Score; Physiological parameter based on Anorectal manometry; Time of balloon expulsion test
General information
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Reason for update
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our research was register in the old version of IRCT, therefore for updating the information, we prefer to do in the new version
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090301001722N18
Registration date:
2018-04-22, 1397/02/02
Registration timing:
prospective
Last update:
2021-01-08, 1399/10/19
Update count:
2
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Registration date
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2018-04-22, 1397/02/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for education
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Expected recruitment start date
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2018-05-07, 1397/02/17
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Expected recruitment end date
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2020-03-10, 1398/12/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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To compare the effects of neuromodulation (transcutaneous tibial nerve stimulation(TTNS)) with manometric biofeedback on physiological and clinical factors in female with functional constipation
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Public title
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Effects of transcutaneous nerve stimulation with biofeedback on physiological and clinical factors in female with constipation
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Female with functional constipation aged between 25 – 55 years
Definition of constipation based on Rome III criteria
Exclusion criteria:
The patient withdrew cooperation
Pregnant or wishing to become pregnant
History of neurologic diseases such as multiple sclerosis, stroke, or spinal cord injury
Metabolic disorder such as diabetes, hypothyroidism, hypercalcaemia
History of Congenital anorectal malformations
History of previous large-bowel surgery or cancer
History of irritable bowel syndrome
Take anticholinergic or other constipating medications
Skin eruptions at the site of stimulation
History of recent surgery to the lower limb
Metal implant in the lower limb
Abnormal rectal sensation
Failure of Traditional treatment
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Age
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From 25 years old to 60 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple Randomization
The name of each group is written on a separate paper and the patient randomly chooses the own intervention group
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-08-30, 1396/06/08
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Ethics committee reference number
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IR.TUMS.FNM.REC.1396.3299
Health conditions studied
1
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Description of health condition studied
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Constipation
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ICD-10 code
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K59.0
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ICD-10 code description
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Constipation
Primary outcomes
1
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Description
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anal canal resting pressure
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Timepoint
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before and after of intervention
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Method of measurement
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anorectal manometry
2
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Description
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rectoanal inhibitory reflex
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Timepoint
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before and after of intervention
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Method of measurement
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anorectal manometry
3
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Description
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urge volume
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Timepoint
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before and after of intervention
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Method of measurement
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anorectal manometry
4
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Description
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max tolerable volume
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Timepoint
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before and after of intervention
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Method of measurement
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anorectal manometry
5
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Description
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max rectal pressure during sraining
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Timepoint
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before and after of intervention
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Method of measurement
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anorectal manometry
6
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Description
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balloon expulsion test
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Timepoint
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before and after of intervention
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Method of measurement
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stopwatch
7
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Description
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bowel movement
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Timepoint
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before and after of intervention
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Method of measurement
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wexner questionnaire
8
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Description
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total score of wexner questionnaire
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Timepoint
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before and after of intervention
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Method of measurement
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wexner questionnaire
9
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Description
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Scores of 8 scales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and physical and mental component summary of SF36
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Timepoint
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Before and after of intervention
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Method of measurement
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SF36 questionnaire
10
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Description
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Score of total and 4 scales (physical discomfort, psychosocial discomfort, worries and discomfort and treatment satisfaction) of Patient Assessment Constipation Quality Of Life (PAC-QOL) questionnaire
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Timepoint
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Before and after of intervention
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Method of measurement
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PAC-QOL questionnaire
Intervention groups
1
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Description
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biofeedback intervention: 5 sessions once a week
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Category
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Rehabilitation
2
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Description
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Transcutaneous Tibial Nerve Stimulation intervention : 12 sessions, three times a week
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available