Transabdominal Electrical Stimulation for Constipation

A Double-blind Pilot Randomised Trial of Transabdominal Interferential Stimulation and Transcutaneous Electrical Nerve Stimulation for Severe Chronic Constipation in Adults Unresponsive to Conservative Treatments

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Device: Interferential Stimulation; Device: TENS stimulation

Detailed 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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age over 18 years
• Rome III defined constipation (frequency of defecation of less than three times a week, straining or sense of incomplete emptying associated with at least 25% of defecations. Lumpy, hard stools or anal digitation for at least 25% of defecations
• Failed Biofeedback
• Competent and willing to complete stimulation at home
• Competent and willing to complete the questionnaires and bowel diaries

Exclusion Criteria:

• Rectal prolapse
• Active inflammatory bowel disease
• Pregnancy or intention to become pregnant during trial
• Spinal cord injuries/cauda equina syndrome
• Other implanted electrical devices
• Allergy to device components
• Neurological disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interferential Stimulation; Medical Device: Interferential stimulation. Stimulation parameters: 4 KHz of carrier stimulation, beat frequency between 80-160Hz, amplitude upto 33mA. Delivered via two 100mm x 50mm adhesive pads placed on the anterior abdominal wall	Device: Interferential Stimulation; Transabdominal interferential electrcial stimulation; Other Names: NeuroTrac® IFC Rehab device (Verity Medical Ltd, UK).
Active Comparator: Standard electrical stimulation; Medical Device: Standard electrical stimulation. Parameters set to provide continuous electrical stimulation at a pulse width of 210µs and a frequency of 14Hz and an amplitude upto 33mA.	Device: TENS stimulation; Transabdominal standard electrical stimulation; Other Names: NeuroTrac® Continence device (Verity Medical Ltd, UK).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)	A validated tool for constipation severity assessment	After 4 weeks of stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Assessment of Constipation Symptoms (PAC-SYM)	A validated tool for constipation severity assessment	After 4 weeks of stimulation
A bowel visual analogue scale	a bowel visual analogue scale (0-100 where 0= 'very unhappy' 100= 'very happy') based on patients' response to the question 'how happy are you with the way your bowel has been functioning'	After 4 weeks of stimulation
Weekly bowel and laxative diary	Standard bowel and laxative diary	one week and 4 weeks of stimulation

Collaborators and Investigators

• Sponsor: St Mark's Hospital Foundation
• Investigators: Study Chair: Alan Warnes, PhD, The London Northwest Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Estimate): October 21, 2016
• Last Update Submitted That Met QC Criteria: October 20, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Constipation; Neuromodulation; Interferential; Transabdominal
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: StMarksHF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No