PainNCT02077270
Pretreatment With Electroacupuncture to Reduce Discomfort
A study testing electroacupuncture in people with Pain, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The main hypothesis is that performance of electroacupuncture before colonoscopy reduces pain during the exam. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- electroacupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to Nov 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult Patients referred for their first colonoscopy in the department of GI in Sheba, Tel Hashomer
Who cannot join
- Ages <18y >75y
- Any prior gastrointestinal endoscopy.
- History of colonic resection.
- Known or suspected stenosis of the colon.
- Pregnancy.
- Inflammatory bowel disease
- Neuropsychiatric disorders or receiving psychotropic drugs.
- Prior knowledge or experience of acupuncture.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba Medical Center
Ramat Gan, 53261
Dan Carter, MD, 97235302197, dan.carter@sheba.health.gov.il
Eytan Bardan, MD, 97235303660, bardan@sheba.health.gov.il
About this study
The main hypothesis is that performance of electroacupuncture before colonoscopy reduces pain during the exam.
Read the detailed description
To assess the efficacy of pre-colonoscopic electroacupuncture in reducing discomfort during colonoscopy.
- Conditions
- Pain
- Being tested
- electroacupuncture
- Keywords
- colonoscopy, acupuncture, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureProcedure or surgery
Patients allocated to this arm will receive electro-acupuncture bilaterally on the following points which are considered relevant both for sedation and abdominal distention:LI4 (Hegu),ii. St36 (Zusanli), Sp6 (Sanyinjiao), St25 (Tianshuv),. Du20 (Baihui),
| Study group | Role | What they receive |
|---|---|---|
| electroacupuncture | Experimental | patients in whom precolonoscopic electroacupuncture is preformed Receives: Procedure: electroacupuncture |
| Sham electroacupuncture | Placebo comparator | sham electroacupuncture Receives: Procedure: electroacupuncture |
| No intervantion | Sham comparator | no intervantion Receives: Procedure: electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of pre-colonoscopic electroacupuncture in reducing discomfort during colonoscopy by measuring sedative drug amounts during colonoscopy
The measurement of the amount of drug added during colonoscopy
Measured: during the colonoscopy and in the hour post procedure
Secondary outcomes (4)
Time of insertion till the cecum.
Time between insertion of the colonoscopy and the image of the cecum
Measured: during colonoscopy
Time of post-colonoscopy recovery as measured by the Aldrete score
Measured: up to 1 hour post colonoscopy
Number of intra-examination adverse events.
Measured: from the begining of the endoscopy and up to 1 hour post procedure
Patient's total satisfaction with the exam and the analgesia
Measured: between the end of the procedure and up to 1 hour post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startJan 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Dan Carter, Gastroenterologist, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077270
- Sponsor's protocol ID
- SHEBA-14-9733-DC-CTIL
- Status last verified
- Nov 2015
- First submitted
- 24 Feb 2014
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatment With Electroacupuncture to Reduce Discomfort
- ClinicalTrials.gov ID
- NCT02077270
- Acronym / sponsor ID
- SHEBA-14-9733-DC-CTIL
- Conditions
- Pain
- Keywords
- colonoscopy, acupuncture, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 4 Mar 2014 (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.
The main hypothesis is that performance of electroacupuncture before colonoscopy reduces pain during the exam.
Detailed description
To assess the efficacy of pre-colonoscopic electroacupuncture in reducing discomfort during colonoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture | Experimental | Procedure: electroacupuncturepatients in whom precolonoscopic electroacupuncture is preformed |
| Sham electroacupuncture | Placebo comparator | Procedure: electroacupuncturesham electroacupuncture |
| No intervantion | Sham comparator | Procedure: electroacupunctureno intervantion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Patients referred for their first colonoscopy in the department of GI in Sheba, Tel Hashomer
Key exclusion criteria (8 listed)
- Ages <18y >75y
- Any prior gastrointestinal endoscopy.
- History of colonic resection.
- Known or suspected stenosis of the colon.
- Pregnancy.
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 |
|---|---|---|
| electroacupuncturePatients allocated to this arm will receive electro-acupuncture bilaterally on the following points which are considered relevant both for sedation and abdominal distention:LI4 (Hegu),ii. St36 (Zusanli), Sp6 (Sanyinjiao), St25 (Tianshuv),. Du20 (Baihui), | Procedure or surgery | No intervantion, Sham electroacupuncture, electroacupuncture |
Primary outcome
Efficacy of pre-colonoscopic electroacupuncture in reducing discomfort during colonoscopy by measuring sedative drug amounts during colonoscopy
Time frame: during the colonoscopy and in the hour post procedure
The measurement of the amount of drug added during colonoscopy
4 secondary outcomes
Time of insertion till the cecum.
Time frame: during colonoscopy
Time of post-colonoscopy recovery as measured by the Aldrete score
Time frame: up to 1 hour post colonoscopy
Number of intra-examination adverse events.
Time frame: from the begining of the endoscopy and up to 1 hour post procedure
Patient's total satisfaction with the exam and the analgesia
Time frame: between the end of the procedure and up to 1 hour post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Pain, run by Sheba Medical Center at 1 site in Israel.
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 8 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: status not confirmed, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Carter, MD (97235302197, dan.carter@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of pre-colonoscopic electroacupuncture in reducing discomfort during colonoscopy by measuring sedative drug amounts during colonoscopy (time frame: during the colonoscopy and in the hour post procedure). 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 17 Nov 2015.