A Phase 1 interventional study of Interferential Stimulation and TENS stimulation in Constipation, sponsored by St Mark's Hospital Foundation. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-21.
Sponsored by St Mark's Hospital Foundation · Phase 1, Interventional, and Treatment
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.
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 14 is below the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →St Mark's Hospital Foundation is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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 interferential electrcial stimulation
Also known as: NeuroTrac® IFC Rehab device (Verity Medical Ltd, UK).
Transabdominal standard electrical stimulation
Also known as: NeuroTrac® Continence device (Verity Medical Ltd, UK).
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)
A validated tool for constipation severity assessment
Time frame: After 4 weeks of stimulation
Patient-Assessment of Constipation Symptoms (PAC-SYM)
A validated tool for constipation severity assessment
Time frame: 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'
Time frame: After 4 weeks of stimulation
Weekly bowel and laxative diary
Standard bowel and laxative diary
Time frame: one week and 4 weeks of stimulation
No study locations are listed for this record.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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St Mark's Hospital Foundation