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

NCT05946967 | Unknown

• 1 other identifier: 2023-128-DM-131
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Constipation

Keywords

CTT; IBS-C; Functional-constipation

Outcome Measures

Primary Outcomes (3)

• Constipation severity

  Constipation severity questionnaire will be used to assess the Constipation Scoring System

  3 months

• Bowel movement assessment

  Number of spontaneous bowel movements, time spent in the toilet, stool form (according to Bristol stool chart) will be assessed with a stool diary

  3 months

• Treatment effect

  After the end of treatment, colon transit study will be repeated to assess its improvement.

  3 months

Secondary Outcomes (1)

• Dose of laxatives

  3 month

Study Arms (2)

Biofeedback with TENS

ACTIVE COMPARATOR

Patients with constipation will undergo biofeedback treatment along with transcutaneous electrical stimulation (TENS)

Other: Biofeedback with TENS

Biofeedback only

SHAM COMPARATOR

Patients with constipation will undergo biofeedback treatment only

Other: Biofeedback only

Interventions

Biofeedback with TENS OTHER

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

Biofeedback with TENS

Biofeedback only OTHER

Constipation patients will be given biofeedback treatment only

Biofeedback only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i) Patient with refractory chronic constipation ii) 18-65 years of age

You may not qualify if:

• i) Patient with uncontrolled diabetes/ untreated thyroid/ organic disease ii) No lower limb iii) \<18 years of age iv) \>65 years of age

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

MeSH Terms

Conditions

Constipation

Interventions

Biofeedback, Psychology; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: July 20, 2023
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07