Transabdominal Electrical Stimulation for Constipation

NCT02941471 | Completed Phase 1 DMC

• 1 other identifier: StMarksHF
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Constipation

Keywords

Constipation; Neuromodulation; Interferential; Transabdominal

Outcome Measures

Primary Outcomes (1)

• Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)

  A validated tool for constipation severity assessment

  After 4 weeks of stimulation

Secondary Outcomes (3)

• Patient-Assessment of Constipation Symptoms (PAC-SYM)

  After 4 weeks of stimulation

• A bowel visual analogue scale

  After 4 weeks of stimulation

• Weekly bowel and laxative diary

  one week and 4 weeks of stimulation

Study Arms (2)

Interferential Stimulation

EXPERIMENTAL

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

Standard electrical stimulation

ACTIVE COMPARATOR

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

Interventions

Interferential Stimulation DEVICE

Transabdominal interferential electrcial stimulation

Also known as: NeuroTrac® IFC Rehab device (Verity Medical Ltd, UK).

Interferential Stimulation

TENS stimulation DEVICE

Transabdominal standard electrical stimulation

Also known as: NeuroTrac® Continence device (Verity Medical Ltd, UK).

Standard electrical stimulation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St Mark's Hospital Foundation: lead

MeSH Terms

Conditions

Constipation

Interventions

Electric Stimulation Therapy; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Alan Warnes, PhD

  The London Northwest Healthcare NHS Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow/PI

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 21, 2016
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 21, 2016

Record last verified: 2016-10