Transabdominal Electrical Stimulation for Constipation

Status Completed

Clinical Trial Summary

Several transabdominal electrical stimulation studies have been reported for constipation in childhood. This study aims to assess the efficacy of this technique in adults with chronic constipation and compare two different electrical therapies.

Clinical Trial Description

Patients with Rome III defined constipation unresponsive to medical and behavioural treatment will be randomised in a double-blind prospective trial to receive either four weeks of transabdominal electrical stimulation (TENS) or Interferential stimulation (IFC). Treatment will be self-administered at home for sixty minutes a day. The response to treatment will be assessed with the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL), the Patient-Assessment of Constipation Symptoms (PAC-SYM) tool and a bowel visual analogue scale (VAS). A bowel diary will be kept a week before and during the final week of stimulation, recording daily bowel frequency.

IFC stimulation is an effective, cheap and low risk intervention which has demonstrated efficacy for dysphagia, urinary incontinence, overactive bladder syndromes and chronic pain. The precise mechanism of its analgesic and pro-kinetic effect is unknown. The intervention is delivered by two separate continuous alternating electrical currents. Two pairs of pad electrodes are arranged in a quadripolar manner where each pair delivers a different frequency of current. It is suggested that this arrangement of stimulation improves colonic propagation. However as direct massage of the abdomen has demonstrated benefit in constipation it is argued that IFC is not a specific requirement and that non-IFC electrical stimulation over the abdomen is sufficient to evoke the same colonic and clinical responses. Owing to these questions the efficacy of this intervention will be further evaluated in adults.

This study has two aims. The primary aim is to evaluate the effectiveness of transabdominal electrical nerve stimulation (TENS) in adult patients with chronic constipation. The secondary aim is to establish whether IFC was superior to non-IFC (TENS) electrical stimulation in adults with chronic constipation. ;

Study Design

Related Conditions & MeSH terms

Constipation

Clinical Trial Details

NCT number	NCT02941471
Study type	Interventional
Source	St Mark's Hospital Foundation
Contact
Status	Completed
Phase	Phase 1
Start date	January 2015
Completion date	November 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05517460` - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center	N/A
Recruiting	`NCT06292949` - Clinical Study of Resistant Starch in Improving Constipation	N/A
Recruiting	`NCT04132661` - MRI Assessment of Mode of Action of Bisacodyl, Single Dose	Phase 4
Terminated	`NCT02839889` - Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation)	Phase 4
Completed	`NCT02726295` - The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study	Phase 4
Recruiting	`NCT02255747` - Anal Dilatation for Infants and Children With Constipation	N/A
Completed	`NCT02246647` - Biomarkers for Intestinal Permeability in Patients With Constipation
Completed	`NCT01566409` - Maintenance Treatment for Children With Constipation	N/A
Completed	`NCT02863848` - Effect of Inulin-type Fructans on Constipated Children.	N/A
Completed	`NCT01710579` - Normal Values in Ano-rectal 3D High Resolution Manometry	N/A
Completed	`NCT01695915` - Diurnal Variation in Rectal Diameter	N/A
Completed	`NCT02658201` - Ultrafast MRI Imaging to Exclude Constipation	N/A
Completed	`NCT01438567` - A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy	Phase 3
Completed	`NCT01411501` - Efficacy and Safety of Acupuncture for Functional Constipation	Phase 3
Completed	`NCT01474499` - A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation	Phase 3
Completed	`NCT01170039` - The Effectiveness of Lubiprostone in Constipated Diabetics	Phase 4
Completed	`NCT00931853` - Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).	Phase 3
Active, not recruiting	`NCT02442115` - Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
Completed	`NCT00994851` - Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.	Phase 3
Terminated	`NCT01003249` - Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.