ConstipationNCT05833191
Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Constipation
A study testing Auricular vagus stimulation and Tibial Nerve Stimulation in people with Constipation, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Constipation is the most common digestive complaint in the general population. Normal stool frequency ranges from at least three times a week to a maximum of two times a day. Constipation can be classified into three main groups as constipation with normal transit time, constipation with slow transit time and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Constipation
- What is being tested?
- Auricular vagus stimulation and Tibial Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 9 Jul 2024
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •Being diagnosed with chronic constipation
Who cannot join
- Metabolic diseases
- Severe heart or kidney disease, previous gastrointestinal, spinal or pelvic surgery other than cholecystectomy, hysterectomy or appendectomy,
- Neurological diseases such as multiple sclerosis, stroke, Parkinson's disease or spinal injury, impaired awareness
- Mini-mental score < 15
- Legal blindness, pregnancy, rectal prolapse, anal fissure, and alternating pattern of constipation and diarrhea.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Medipol hospital
Istanbul, Istanbul Avrupa Kitasi, 34353
Medipol hospital
Istanbul, 34070
About this study
Constipation is the most common digestive complaint in the general population. Normal stool frequency ranges from at least three times a week to a maximum of two times a day. Constipation can be classified into three main groups as constipation with normal transit time, constipation with slow transit time and dyssynergic defecation disorders.
Read the detailed description
In chronic constipation, treatment should be directed towards the underlying cause. In the treatment of chronic constipation, lifestyle changes and physiotherapy are in the first place, pharmacological treatment is in the second place, and surgical treatment is in the third place. Physiotherapy modalities such as defecation training, classical massage, electrical stimulation, anorectal biofeedback and exercise training can be used in the treatment of chronic constipation.
- Conditions
- Constipation
- Being tested
- Auricular vagus stimulation, Tibial Nerve Stimulation
- Keywords
- vagus, tibial nerve stimülation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular vagus stimulationDevice
When the nervus tibialis approaches the medial malleolus, it approaches the surface. In this study, bilateral transcutaneous electrical nerve stimulation (TENS) electrodes will be placed under the medial malleolus approximately at the point where the tibialis nerve contacts the surface.
Tibial Nerve StimulationDevice
When the nervus tibialis approaches the medial malleolus, it approaches the surface. In this study, bilateral transcutaneous electrical nerve stimulation (TENS) electrodes will be placed under the medial malleolus approximately at the point where the tibialis nerve contacts the surface.
| Study group | Role | What they receive |
|---|---|---|
| Auricular vagus stimulation | Experimental | Non-invasive transcutaneous devices stimulate the vagus nerve via the auricular route or from the carotid. Receives: Device: Auricular vagus stimulation |
| Tibial Nerve Stimulation | Experimental | Transcutaneous tibial nerve stimulation (TTNS) is reported to be beneficial for fecal and urinary incontinence. A review of the literature showed that there are very few studies using TTNS that have been shown to be effective for constipation. Receives: Device: Tibial Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bristol Stool Scale
Bristol Stool Scale (BGS) In the scale, the type of stool is classified into 7 different groups. In the Bristol stool scale, the intestinal transit time of stool is evaluated over seven different stool types. According to BGS, 1-2 points are "hard stools", 3-4-5 points are "normal stools" and 6-7 points are "soft-watery stools (diarrhea)".
Measured: 4 weeks
Pelvic Pain Impact Questionnaire
The clinical assessment of the effect of pelvic pain on women consists of 10 questions. However, the first 8 questions are scored. The range of points to be taken from the questionnaire varies between 1 and 32. As the score to be obtained from the questionnaire increases, the degree of functional limitation of pelvic pain on the person also increases.
Measured: 4 weeks
Superficial Electromyography Biofeedback
Before starting the treatment, the target that the patient wants to reach is determined. With the "set target" feature on the device, tensing and relaxation are practiced for 10 seconds and the average target is determined. Then, the target is created by taking the percentage of this determined target. Since the goal in this study is relaxation, the patient is asked to decrease the value on the graph during the session.
Measured: 4 weeks
Constipation Severity Scale
The lowest possible total score is 0, and the highest is 73. A high score from the scale indicates that the symptoms are serious. The highest score that can be obtained from the five-point Likert-type scale is 140, and the lowest score is 28. It is thought that as the scores obtained from the scale increase, the quality of life is negatively affected.
Measured: 4 weeks
Autonomic nervous system device
In the study, the autonomic nervous system will be evaluated with the Polar H10 device. By connecting the device to a smart phone via bluetooth, the data will be recorded and the software supported by the device will be used for the analysis of the data. A measurement will be made with the participant in a sitting position and lasting up to 3 minutes.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start15 Apr 2023
- Primary completion15 May 2023
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be included in a 12-session treatment program over four weeks.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833191
- Sponsor's protocol ID
- Chronic Constipation
- Status last verified
- Jul 2024
- First submitted
- 17 Apr 2023
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tan K, Wells CI, Dinning P, Bissett IP, O'Grady G. Placebo Response Rates in Electrical Nerve Stimulation Trials for Fecal Incontinence and Constipation: A Systematic Review and Meta-Analysis. Neuromodulation. 2020 Dec;23(8):1108-1116. doi: 10.1111/ner.13092. Epub 2019 Dec 30.
PubMed 31889364
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Constipation
- ClinicalTrials.gov ID
- NCT05833191
- Acronym / sponsor ID
- Chronic Constipation
- Conditions
- Constipation
- Keywords
- vagus, tibial nerve stimülation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 27 Apr 2023 (actual)
- 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.
Constipation is the most common digestive complaint in the general population. Normal stool frequency ranges from at least three times a week to a maximum of two times a day. Constipation can be classified into three main groups as constipation with normal transit time, constipation with slow transit time and dyssynergic defecation disorders.
Detailed description
In chronic constipation, treatment should be directed towards the underlying cause. In the treatment of chronic constipation, lifestyle changes and physiotherapy are in the first place, pharmacological treatment is in the second place, and surgical treatment is in the third place. Physiotherapy modalities such as defecation training, classical massage, electrical stimulation, anorectal biofeedback and exercise training can be used in the treatment of chronic constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study will be included in a 12-session treatment program over four weeks.
| Arm | Type | Receives |
|---|---|---|
| Auricular vagus stimulation | Experimental | Device: Auricular vagus stimulationNon-invasive transcutaneous devices stimulate the vagus nerve via the auricular route or from the carotid. |
| Tibial Nerve Stimulation | Experimental | Device: Tibial Nerve StimulationTranscutaneous tibial nerve stimulation (TTNS) is reported to be beneficial for fecal and urinary incontinence. A review of the literature showed that there are very few studies using TTNS that have been shown to be effective for constipation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •Being diagnosed with chronic constipation
Key exclusion criteria (5 listed)
- Metabolic diseases
- Severe heart or kidney disease, previous gastrointestinal, spinal or pelvic surgery other than cholecystectomy, hysterectomy or appendectomy,
- Neurological diseases such as multiple sclerosis, stroke, Parkinson's disease or spinal injury, impaired awareness
- Mini-mental score < 15
- Legal blindness, pregnancy, rectal prolapse, anal fissure, and alternating pattern of constipation and diarrhea.
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 |
|---|---|---|
| Auricular vagus stimulationWhen the nervus tibialis approaches the medial malleolus, it approaches the surface. In this study, bilateral transcutaneous electrical nerve stimulation (TENS) electrodes will be placed under the medial malleolus approximately at the point where the tibialis nerve contacts the surface. | Device | Auricular vagus stimulation |
| Tibial Nerve StimulationWhen the nervus tibialis approaches the medial malleolus, it approaches the surface. In this study, bilateral transcutaneous electrical nerve stimulation (TENS) electrodes will be placed under the medial malleolus approximately at the point where the tibialis nerve contacts the surface. | Device | Tibial Nerve Stimulation |
Primary outcome
Bristol Stool Scale
Time frame: 4 weeks
Bristol Stool Scale (BGS) In the scale, the type of stool is classified into 7 different groups. In the Bristol stool scale, the intestinal transit time of stool is evaluated over seven different stool types. According to BGS, 1-2 points are "hard stools", 3-4-5 points are "normal stools" and 6-7 points are "soft-watery stools (diarrhea)".
Pelvic Pain Impact Questionnaire
Time frame: 4 weeks
The clinical assessment of the effect of pelvic pain on women consists of 10 questions. However, the first 8 questions are scored. The range of points to be taken from the questionnaire varies between 1 and 32. As the score to be obtained from the questionnaire increases, the degree of functional limitation of pelvic pain on the person also increases.
Superficial Electromyography Biofeedback
Time frame: 4 weeks
Before starting the treatment, the target that the patient wants to reach is determined. With the "set target" feature on the device, tensing and relaxation are practiced for 10 seconds and the average target is determined. Then, the target is created by taking the percentage of this determined target. Since the goal in this study is relaxation, the patient is asked to decrease the value on the graph during the session.
Constipation Severity Scale
Time frame: 4 weeks
The lowest possible total score is 0, and the highest is 73. A high score from the scale indicates that the symptoms are serious. The highest score that can be obtained from the five-point Likert-type scale is 140, and the lowest score is 28. It is thought that as the scores obtained from the scale increase, the quality of life is negatively affected.
Autonomic nervous system device
Time frame: 4 weeks
In the study, the autonomic nervous system will be evaluated with the Polar H10 device. By connecting the device to a smart phone via bluetooth, the data will be recorded and the software supported by the device will be used for the analysis of the data. A measurement will be made with the participant in a sitting position and lasting up to 3 minutes.
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 10 Jul 2024.
- Background: PubMed 31889364Tan K, Wells CI, Dinning P, Bissett IP, O'Grady G. Placebo Response Rates in Electrical Nerve Stimulation Trials for Fecal Incontinence and Constipation: A Systematic Review and Meta-Analysis. Neuromodulation. 2020 Dec;23(8):1108-1116. doi: 10.1111/ner.13092. Epub 2019 Dec 30.
- Individual participant dataSharing planned: No
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular vagus stimulation and Tibial Nerve Stimulation in people with Constipation, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).
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 1 inclusion and 5 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 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Bristol Stool Scale (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05833191, which also lists 1 linked publication.
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 10 Jul 2024.