ConstipationPhase 1NCT02941471
Transabdominal Electrical Stimulation for Constipation
A Phase 1 study testing Interferential Stimulation and TENS stimulation in people with Constipation, run by St Mark's Hospital Foundation.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Interferential Stimulation and TENS stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Nov 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Constipation
- Being tested
- Interferential Stimulation, TENS stimulation
- Keywords
- Constipation, Neuromodulation, Interferential, Transabdominal
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferential StimulationDevice
Also called NeuroTrac® IFC Rehab device (Verity Medical Ltd, UK).
Transabdominal interferential electrcial stimulation
TENS stimulationDevice
Also called NeuroTrac® Continence device (Verity Medical Ltd, UK).
Transabdominal standard electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: TENS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)
A validated tool for constipation severity assessment
Measured: After 4 weeks of stimulation
Secondary outcomes (3)
Patient-Assessment of Constipation Symptoms (PAC-SYM)
A validated tool for constipation severity assessment
Measured: 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'
Measured: After 4 weeks of stimulation
Weekly bowel and laxative diary
Standard bowel and laxative diary
Measured: one week and 4 weeks of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Mark's Hospital Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fareed Iqbal, St Mark's Hospital Foundation
- Investigators
- Alan Warnes, PhD, Study chair, The London Northwest Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941471
- Sponsor's protocol ID
- StMarksHF
- Status last verified
- Oct 2016
- First submitted
- 18 Oct 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02941471
- Acronym / sponsor ID
- StMarksHF
- Conditions
- Constipation
- Keywords
- Constipation, Neuromodulation, Interferential, Transabdominal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- St Mark's Hospital FoundationUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interferential Stimulation | Experimental | Device: Interferential StimulationMedical 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 |
| Standard electrical stimulation | Active comparator | Device: TENS stimulationMedical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Rectal prolapse
- Active inflammatory bowel disease
- Pregnancy or intention to become pregnant during trial
- Spinal cord injuries/cauda equina syndrome
- Other implanted electrical devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferential StimulationAlso: NeuroTrac® IFC Rehab device (Verity Medical Ltd, UK).Transabdominal interferential electrcial stimulation | Device | Interferential Stimulation |
| TENS stimulationAlso: NeuroTrac® Continence device (Verity Medical Ltd, UK).Transabdominal standard electrical stimulation | Device | Standard electrical stimulation |
Primary outcome
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)
Time frame: After 4 weeks of stimulation
A validated tool for constipation severity assessment
3 secondary outcomes
Patient-Assessment of Constipation Symptoms (PAC-SYM)
Time frame: After 4 weeks of stimulation
A bowel visual analogue scale
Time frame: After 4 weeks of stimulation
Weekly bowel and laxative diary
Time frame: one week and 4 weeks of stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Warnes, PhD study chair
The London Northwest Healthcare NHS Trust
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Interferential Stimulation and TENS stimulation in people with Constipation, run by St Mark's Hospital Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) (time frame: After 4 weeks of stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.