PainNCT01247935
Electroacupuncture and Trancutaneous Electrical Nervous Stimulation (TENS) for Colonoscopy Analgesia
A study testing Acupuncture and Transcutaneous electrical stimulation in people with Pain, run by Azienda Per I Servizi Sanitari N. 2 Isontina at 1 site in Italy.
Trial summary
To compare the effectiveness of acupuncture and transcutaneous electrical nervous stimulation (TENS) in reducing patient's discomfort during colonoscopy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Acupuncture and Transcutaneous electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2010to Mar 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients scheduled for colonoscopy and in whom deep sedation was not planned will be included in the study
Who cannot join
- age > 80 and less than 18 years old, severe cardiac or pulmonary disease, anticoagulant, benzodiazepines, antidepressants, opiates therapies, severe cognitive impairment, uncontrolled hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electroacupuncture and Trancutaneous Electrical Nervous Stimulation Analgesia for Colonoscopy: a Prospective, Randomized, Controlled Study
To compare the effectiveness of acupuncture and transcutaneous electrical nervous stimulation (TENS) in reducing patient's discomfort during colonoscopy
Read the detailed description
Evaluation patient's pain and discomfort during colonoscopy, using two non invasive analgesic methods.
- Conditions
- Pain
- Being tested
- Acupuncture, Transcutaneous electrical stimulation, Control
- Keywords
- Pain, Acupuncture, Transcutaneous electrical nerve stimulation, Colonoscopy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Also called Electroacupuncture
Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy
Transcutaneous electrical stimulationOther
Also called TENS
Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy
ControlOther
Also called No treatment (only sedative drugs if request)
Patients are monitored for pain and discomfort
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy Receives: Other: Acupuncture |
| transcutaneous electrical stimulation | Experimental | Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy Receives: Other: Transcutaneous electrical stimulation |
| Control | No intervention | patient are monitored for pain and discomfort Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of patients' discomfort and pain during and at the end of colonoscopy both in acupuncture group and in TENS group compare with controls.
Measured: During colonoscopy, we'll evaluate pain at colorectal, left, trasversal and right colon position of colonscope. At the end of colonoscopy, before discharge, we' ll evaluate patient's general discomfort.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Per I Servizi Sanitari N. 2 Isontina
- Sponsor type
- University, hospital or other
- Investigators
- Corrado Thomann, MD, Principal investigator, ICU Gorizia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247935
- Sponsor's protocol ID
- 34115/14
- Status last verified
- Jun 2010
- First submitted
- 12 Nov 2010
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sung JJ. Acupuncture for gastrointestinal disorders: myth or magic. Gut. 2002 Nov;51(5):617-9. doi: 10.1136/gut.51.5.617.
PubMed 12377792Camilleri M. Editorial: is adequate relief fatally flawed or adequate as an end point in irritable bowel syndrome? Am J Gastroenterol. 2009 Apr;104(4):920-2. doi: 10.1038/ajg.2009.20. Epub 2009 Mar 17.
PubMed 19293789Han JS. Acupuncture and endorphins. Neurosci Lett. 2004 May 6;361(1-3):258-61. doi: 10.1016/j.neulet.2003.12.019.
PubMed 15135942Fanti L, Gemma M, Passaretti S, Guslandi M, Testoni PA, Casati A, Torri G. Electroacupuncture analgesia for colonoscopy. a prospective, randomized, placebo-controlled study. Am J Gastroenterol. 2003 Feb;98(2):312-6. doi: 10.1111/j.1572-0241.2003.07231.x.
PubMed 12591047Robinson R, Darlow S, Wright SJ, Watters C, Carr I, Gadsby G, Mayberry J. Is transcutaneous electrical nerve stimulation an effective analgesia during colonoscopy? Postgrad Med J. 2001 Jul;77(909):445-6. doi: 10.1136/pmj.77.909.445.
PubMed 11423594
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture and Trancutaneous Electrical Nervous Stimulation Analgesia for Colonoscopy: a Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT01247935
- Acronym / sponsor ID
- 34115/14
- Conditions
- Pain
- Keywords
- Pain, Acupuncture, Transcutaneous electrical nerve stimulation, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Azienda Per I Servizi Sanitari N. 2 IsontinaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 25 Nov 2010 (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.
To compare the effectiveness of acupuncture and transcutaneous electrical nervous stimulation (TENS) in reducing patient's discomfort during colonoscopy
Detailed description
Evaluation patient's pain and discomfort during colonoscopy, using two non invasive analgesic methods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: AcupunctureElectrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy |
| transcutaneous electrical stimulation | Experimental | Other: Transcutaneous electrical stimulationElectrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy |
| Control | No intervention | Other: Controlpatient are monitored for pain and discomfort |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients scheduled for colonoscopy and in whom deep sedation was not planned will be included in the study
Key exclusion criteria (1 listed)
- age > 80 and less than 18 years old, severe cardiac or pulmonary disease, anticoagulant, benzodiazepines, antidepressants, opiates therapies, severe cognitive impairment, uncontrolled hypertension.
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 |
|---|---|---|
| AcupunctureAlso: ElectroacupunctureElectrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy | Other | Acupuncture |
| Transcutaneous electrical stimulationAlso: TENSElectrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy | Other | transcutaneous electrical stimulation |
| ControlAlso: No treatment (only sedative drugs if request)Patients are monitored for pain and discomfort | Other | Control |
Primary outcome
Evaluation of patients' discomfort and pain during and at the end of colonoscopy both in acupuncture group and in TENS group compare with controls.
Time frame: During colonoscopy, we'll evaluate pain at colorectal, left, trasversal and right colon position of colonscope. At the end of colonoscopy, before discharge, we' ll evaluate patient's general discomfort.
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 12 Jul 2011.
- Background: PubMed 12377792Sung JJ. Acupuncture for gastrointestinal disorders: myth or magic. Gut. 2002 Nov;51(5):617-9. doi: 10.1136/gut.51.5.617.
- Background: PubMed 19293789Camilleri M. Editorial: is adequate relief fatally flawed or adequate as an end point in irritable bowel syndrome? Am J Gastroenterol. 2009 Apr;104(4):920-2. doi: 10.1038/ajg.2009.20. Epub 2009 Mar 17.
- Background: PubMed 15135942Han JS. Acupuncture and endorphins. Neurosci Lett. 2004 May 6;361(1-3):258-61. doi: 10.1016/j.neulet.2003.12.019.
- Background: PubMed 12591047Fanti L, Gemma M, Passaretti S, Guslandi M, Testoni PA, Casati A, Torri G. Electroacupuncture analgesia for colonoscopy. a prospective, randomized, placebo-controlled study. Am J Gastroenterol. 2003 Feb;98(2):312-6. doi: 10.1111/j.1572-0241.2003.07231.x.
- Background: PubMed 11423594Robinson R, Darlow S, Wright SJ, Watters C, Carr I, Gadsby G, Mayberry J. Is transcutaneous electrical nerve stimulation an effective analgesia during colonoscopy? Postgrad Med J. 2001 Jul;77(909):445-6. doi: 10.1136/pmj.77.909.445.
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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.
Corrado Thomann, MD principal investigator
ICU Gorizia Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Transcutaneous electrical stimulation in people with Pain, run by Azienda Per I Servizi Sanitari N. 2 Isontina at 1 site in Italy.
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 1 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 12 Jul 2011. 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 Italy. 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?
Evaluation of patients' discomfort and pain during and at the end of colonoscopy both in acupuncture group and in TENS group compare with controls. (time frame: During colonoscopy, we'll evaluate pain at colorectal, left, trasversal and right colon position of colonscope. At the end of colonoscopy, before discharge, we' ll evaluate patient's general discomfort.). 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 NCT01247935, which also lists 5 linked publications.
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 12 Jul 2011.