PainPhase 3NCT01751815
Acu-TENS for Pain Relief During Colonoscopy
A Phase 3 study testing Acu-TENS in people with Pain, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Background: Colonoscopy is often regarded as a painful and unpleasant procedure. Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) is a non-invasive modality that has been used successfully to treat pain of various origins, but few good-quality studies have evaluated its role in treating pain and… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain
- What is being tested?
- Acu-TENS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Dec 2013
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Consecutive patients (aged between 18 and 60 years) undergoing first-time elective day-case colonoscopy
- Patients with American Society of Anesthesiologists (ASA) grading I-II
- Informed consent available
Who cannot join
- Patients with previous experience of acupuncture or Acu-TENS
- Patients with previous history of colorectal surgery
- Patients who are diagnosed with irritable bowel syndrome according to Rome III criteria
- Patients with chronic pain syndrome
- Patients with psychiatric disorder
- Patients with poor cognitive function
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- Patients with renal impairment
- Patients with obstructive sleep apnea syndrome
- Patients with cardiac arrhythmias
- Patients with cardiac pacemaker
- Patients who are pregnant
- Patients who are allergic to the Acu-TENS electrodes or Propofol/Alfentanil
Trial locations and contacts
1 site in 1 country.
China1 site
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong SAR
About this study
Official title: The Application of Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for Pain Relief During Colonoscopy: a Prospective, Randomized, Placebo-controlled Study
Background:
Colonoscopy is often regarded as a painful and unpleasant procedure. Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) is a non-invasive modality that has been used successfully to treat pain of various origins, but few good-quality studies have evaluated its role in treating pain and anxiety during colonoscopy.
Read more
Objective:
To investigate the efficacy of Acu-TENS in reducing procedure-related pain and the consumption of sedatives/analgesics during colonoscopy.
Design:
Prospective, randomized, placebo-controlled study.
Subjects:
One hundred and twenty eight consecutive patients undergoing first-time elective day-case colonoscopy without previous experience of acupuncture/Acu-TENS will be recruited.
Interventions:
Patients will be randomized to receive either 45 minutes of Acu-TENS or placebo-TENS before colonoscopy. The acupoints relevant to the treatment of abdominal pain and distension, including Zusanli, Hegu, Neiguan, Tianshu, and Dachangshu will be used. For the placebo-TENS group, a non-conductive plastic film will be placed between the acupoint and the electrode so that no current will be transmitted. Acu-TENS and placebo-TENS will be continued throughout colonoscopy. A mixture of Propofol and Alfentanil, delivered by a patient-controlled syringe pump, will be used for sedation/analgesia in both groups.
Outcome measures:
Primary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary outcomes: pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time, and episodes of hypotension/desaturation.
- Conditions
- Pain
- Being tested
- Acu-TENS, Placebo-TENS
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acu-TENSProcedure or surgery
Patients randomized to the experimental group will receive Acu-TENS on acupoints relevant to the treatment of abdominal pain and distension, including Zusanli (stomach meridian ST-36), Hegu (large intestine meridian LI-4), Neiguan (pericardium meridian PC-6), Tianshu (stomach meridian ST-25), and Dachangshu (bladder meridian BL-25).
Placebo-TENSProcedure or surgery
Patients randomized to the control group will receive placebo-TENS at the same acupoints.
| Study group | Role | What they receive |
|---|---|---|
| Acu-TENS | Experimental | Not described Receives: Procedure: Acu-TENS |
| Placebo-TENS | Sham comparator | Not described Receives: Procedure: Placebo-TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of patient-controlled sedation/analgesia consumed
Measured: During the procedure (up to 1 day)
Secondary outcomes (9)
Pain score
Using a 10-cm unscaled visual analog scale; 0 = no pain, 10 = very painful
Measured: During the procedure (up to 1 day)
Patients' satisfaction score
Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied
Measured: During the procedure (up to 1 day)
Patients' willingness to repeat the procedure
Measured: Up to 1 day
Endoscopists' satisfaction score
Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied
Measured: During the procedure (up to 1 day)
Cecal intubation rate
Complete colonoscopy is defined as identification of ileocecal valve
Measured: During the procedure (up to 1 day)
Cecal intubation time
The time from introduction of the colonoscope to the cecum
Measured: During the procedure (up to 1 day)
Total procedure time
Measured: During the procedure (up to 1 day)
Episodes of hypotension
Defined as systolic blood pressure <90 mmHg
Measured: During the procedure (up to 1 day)
Episodes of desaturation
Defined as SaO2 <90%
Measured: During the procedure (up to 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
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 Chinese University of Hong KongThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon S. M. Ng, Chinese University of Hong Kong
- Investigators
- Simon SM Ng, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751815
- Sponsor's protocol ID
- CRE-2011.442-T
- Status last verified
- Feb 2014
- First submitted
- 14 Dec 2012
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for Pain Relief During Colonoscopy: a Prospective, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01751815
- Acronym / sponsor ID
- CRE-2011.442-T
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Dec 2012 (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.
Background:
Colonoscopy is often regarded as a painful and unpleasant procedure. Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) is a non-invasive modality that has been used successfully to treat pain of various origins, but few good-quality studies have evaluated its role in treating pain and anxiety during colonoscopy.
Objective:
To investigate the efficacy of Acu-TENS in reducing procedure-related pain and the consumption of sedatives/analgesics during colonoscopy.
Design:
Prospective, randomized, placebo-controlled study.
Subjects:
One hundred and twenty eight consecutive patients undergoing first-time elective day-case colonoscopy without previous experience of acupuncture/Acu-TENS will be recruited.
Interventions:
Patients will be randomized to receive either 45 minutes of Acu-TENS or placebo-TENS before colonoscopy. The acupoints relevant to the treatment of abdominal pain and distension, including Zusanli, Hegu, Neiguan, Tianshu, and Dachangshu will be used. For the placebo-TENS group, a non-conductive plastic film will be placed between the acupoint and the electrode so that no current will be transmitted. Acu-TENS and placebo-TENS will be continued throughout colonoscopy. A mixture of Propofol and Alfentanil, delivered by a patient-controlled syringe pump, will be used for sedation/analgesia in both groups.
Outcome measures:
Primary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary outcomes: pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time, and episodes of hypotension/desaturation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acu-TENS | Experimental | Procedure: Acu-TENS |
| Placebo-TENS | Sham comparator | Procedure: Placebo-TENS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Consecutive patients (aged between 18 and 60 years) undergoing first-time elective day-case colonoscopy
- Patients with American Society of Anesthesiologists (ASA) grading I-II
- Informed consent available
Key exclusion criteria (12 listed)
- Patients with previous experience of acupuncture or Acu-TENS
- Patients with previous history of colorectal surgery
- Patients who are diagnosed with irritable bowel syndrome according to Rome III criteria
- Patients with chronic pain syndrome
- Patients with psychiatric disorder
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 |
|---|---|---|
| Acu-TENSPatients randomized to the experimental group will receive Acu-TENS on acupoints relevant to the treatment of abdominal pain and distension, including Zusanli (stomach meridian ST-36), Hegu (large intestine meridian LI-4), Neiguan (pericardium meridian PC-6), Tianshu (stomach meridian ST-25), and Dachangshu (bladder meridian BL-25). | Procedure or surgery | Acu-TENS |
| Placebo-TENSPatients randomized to the control group will receive placebo-TENS at the same acupoints. | Procedure or surgery | Placebo-TENS |
Primary outcome
Dose of patient-controlled sedation/analgesia consumed
Time frame: During the procedure (up to 1 day)
9 secondary outcomes
Pain score
Time frame: During the procedure (up to 1 day)
Patients' satisfaction score
Time frame: During the procedure (up to 1 day)
Patients' willingness to repeat the procedure
Time frame: Up to 1 day
Endoscopists' satisfaction score
Time frame: During the procedure (up to 1 day)
Cecal intubation rate
Time frame: During the procedure (up to 1 day)
Cecal intubation time
Time frame: During the procedure (up to 1 day)
Total procedure time
Time frame: During the procedure (up to 1 day)
Episodes of hypotension
Time frame: During the procedure (up to 1 day)
Episodes of desaturation
Time frame: During the procedure (up to 1 day)
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 11 Feb 2014.
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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.
Simon SM Ng, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acu-TENS in people with Pain, run by Chinese University of Hong Kong at 1 site in China.
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 3 inclusion and 12 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 11 Feb 2014. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Dose of patient-controlled sedation/analgesia consumed (time frame: During the procedure (up to 1 day)). 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 11 Feb 2014.