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Colon Transit Study for Chronic Constipation Assessment and Therapy by Biofeedback With and Without TENS

NCT05946967 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-07-14

No results posted yet for this study

Summary

One of the most challenging functional gastrointestinal illnesses (FGID) to manage is constipation, which is a widespread issue. The fact that constipation can be caused by a variety of conditions, including slow colon transit, faecal evacuation disorder, or a combination of both slow colon transit and faecal evacuation disorder, is one of the main reasons it is challenging to treat. Treatment options vary based on the pathogenetic mechanism; for instance, biofeedback, botulinum toxin injections in the puborectal sling, or transcutaneous electrical nerve stimulation (TENS) are required to treat faecal evacuation problem. On the other hand, prucalopride and other colokinetic drugs as well as drugs that promote high amplitude propagating contractions, including bisacodyl and sodium pyrosulphate, are used to treat slow transit constipation. Sometimes faecal evacuation disorders that inhibit the evacuation of the transit markers can cause slow colon transit times; these secondary sluggish colon transit times have been shown to improve with biofeedback therapy alone. Even though the causes of faecal evacuation disorders are not fully understood, it is known that abnormal neuromuscular function is the result. A few workers have stimulated the posterior tibial nerve, another sacral plexus branch, non-invasively with TENS. Studies on the use of biofeedback in the treatment of patients with faecal evacuation problems are lacking. Accordingly, we wish to undertake a prospective study with following aims: (i) To assess safety and efficacy of colon transit study by an indigenous radio opaque marker to identify the mechanism of constipation and to assess outcome of treatment (improvement of transit time). (ii) To assess the efficacy of pathogenesisdirected therapy such as biofeedback with or without TENS for posterior tibial nerve to treat fecal evacuation disorder. (iii) To assess colon transit following treatment of fecal evacuation disorder with either biofeedback alone or biofeedback with TENS for posterior tibial nerve.

Conditions

Interventions

OTHER

Biofeedback with TENS

Constipation patients will be given biofeedback treatment along with transcutaneous electrical stimulation (TENS) of posterior tibial nerve

OTHER

Biofeedback only

Constipation patients will be given biofeedback treatment only

Sponsors & Collaborators

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-20
Primary Completion
2023-09-30
Completion
2023-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05946967 on ClinicalTrials.gov