Disease Status of Pancreatobiliary Tract , ( Especially Who Need to Undergo Pancreaticoduodenectomy)Phase 3NCT03619343
Postoperative Muscular Pain, ETOIMS (Electrical Twitch Obstructive Intramuscular Stimulation)
A Phase 3 study testing ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation) in people with Disease Status of Pancreatobiliary Tract , ( Especially Who Need to Undergo Pancreaticoduodenectomy), run by Yonsei University at 1 site in South Korea.
Trial summary
Pancreaticoduodenectomy is inevitably an operation requiring extensive skin and muscle incision, resulting in postoperative pain resulting in limitation of the patient's early exercise and function. ETOIMS(Electrical Twitch Obstructive Intramuscular Stimulation) is used to relieve muscle pain and relax muscles. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Disease Status of Pancreatobiliary Tract , ( Especially Who Need to Undergo Pancreaticoduodenectomy)
- What is being tested?
- ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 May 2018to 18 Jun 2019
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing pancreatoduodenectomy in Gangnam Severance Hospital, Seoul, Korea
- Patients who are able to perform daily activities before surgery and were able to walk independently.
- Adults over 20
Who cannot join
- Patients with history of previous open surgery
- Patients who are not able to exercise due to severe musculoskeletal pain except surgery-related diseases
- Patients who can not walk because of difficulty breathing related to myalgia
- Patients who can not exercise due to severe musculoskeletal pain
- Patients who had a limb defect before surgery and were unable to walk without assistive devices and others
- Pregnant / lactating mothers
Show all 9Show fewer
- Patients who have cognitive impairment and can not answer the questionnaire
- Patients with Pacemaker
- Patients who can not read the consent form
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
GangnamSeverance Hospital
Seoul, 00000
Joon Seong Park, 82-2-2019-3375, JSPARK330@yuhs.ac
About this study
Official title: A New Treatment Modality for the Postoperative Muscular Pain Management in Pylorus Preserving Pancreaticoduodenectomy: a Double-blind Randomized Control Trial
Pancreaticoduodenectomy is inevitably an operation requiring extensive skin and muscle incision, resulting in postoperative pain resulting in limitation of the patient's early exercise and function. ETOIMS(Electrical Twitch Obstructive Intramuscular Stimulation) is used to relieve muscle pain and relax muscles. ETOIMS is a method to relieve pain by stimulating muscle in myofascial pain syndrome. ETOIMS as an effective new treatment for pain after pylorus preserving pancreaticoduodenectomy.
- Conditions
- Disease Status of Pancreatobiliary Tract , ( Especially Who Need to Undergo Pancreaticoduodenectomy)
- Being tested
- ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation)Procedure or surgery
When the abdominal wound is closed, the operator performs needle insertion at 14 sites near the incision site under the guidance of ultrasonography. When the needle is in the abdominal muscle, the operator performs muscle stimulation for about 10 seconds per needle insertion.
| Study group | Role | What they receive |
|---|---|---|
| No ETOIMS arm | Experimental | When the abdominal wound is closed, the operator performs needle insertion at 14 sites near the incision site under the guidance of ultrasonography. Receives: Procedure: ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation) |
| ETOIMS arm | Active comparator | When the abdominal wound is closed, the operator performs needle insertion at 14 sites near the incision site under the guidance of ultrasonography. When the needle is in the abdominal muscle, the operator performs muscle stimulation for about 10 seconds per needle insertion. Receives: Procedure: ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain: VAS (visual analogue scale)
The primary outcome of this study was the postoperative pain score (VAS score) in patients undergoing ETOIMS during surgery. The type of surgery in the experimental group and the control group is the same and the same analgesic agent (IV PCA, Wound PCA) is used. The pain score is measured at 7 o'clock every morning from the day following surgery to discharge (about Postoperative day 10) to confirm the reduced pattern.
Measured: AM 7:00 morning at Preoperative day and the day following surgery before discharge (Postoperative day 1 - Postoperative day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start28 May 2018
- Primary completion18 Feb 2019 (estimated)
- Study completion18 Jun 2019 (estimated)
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 Disease Status of Pancreatobiliary Tract , ( Especially Who Need to Undergo Pancreaticoduodenectomy)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Model description
- Control Intervention : ETOIMS apply group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Seong Park, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619343
- Sponsor's protocol ID
- 3-2018-0100
- Status last verified
- Aug 2018
- First submitted
- 27 Jul 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park J, Kim HS, Park JH, Park YG, Shin S, Park JE, Hwang S, Jun SY, Park JS. Effectiveness of Intramuscular Electrical Stimulation on Postsurgical Nociceptive Pain for Patients Undergoing Open Pancreaticoduodenectomy: A Randomized Clinical Trial. J Am Coll Surg. 2020 Sep;231(3):339-350. doi: 10.1016/j.jamcollsurg.2020.06.008. Epub 2020 Jul 2.
PubMed 32623088
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Treatment Modality for the Postoperative Muscular Pain Management in Pylorus Preserving Pancreaticoduodenectomy: a Double-blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03619343
- Acronym / sponsor ID
- 3-2018-0100
- Conditions
- Disease Status of Pancreatobiliary Tract , ( Especially Who Need to Undergo Pancreaticoduodenectomy)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- 18 Feb 2019 (estimated)
- Study completion
- 18 Jun 2019 (estimated)
- First posted
- 7 Aug 2018 (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.
Pancreaticoduodenectomy is inevitably an operation requiring extensive skin and muscle incision, resulting in postoperative pain resulting in limitation of the patient's early exercise and function. ETOIMS(Electrical Twitch Obstructive Intramuscular Stimulation) is used to relieve muscle pain and relax muscles. ETOIMS is a method to relieve pain by stimulating muscle in myofascial pain syndrome. ETOIMS as an effective new treatment for pain after pylorus preserving pancreaticoduodenectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Control Intervention : ETOIMS apply group
| Arm | Type | Receives |
|---|---|---|
| No ETOIMS arm | Experimental | Procedure: ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation)When the abdominal wound is closed, the operator performs needle insertion at 14 sites near the incision site under the guidance of ultrasonography. |
| ETOIMS arm | Active comparator | Procedure: ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation)When the abdominal wound is closed, the operator performs needle insertion at 14 sites near the incision site under the guidance of ultrasonography. When the needle is in the abdominal muscle, the operator performs muscle stimulation for about 10 seconds per needle insertion. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing pancreatoduodenectomy in Gangnam Severance Hospital, Seoul, Korea
- Patients who are able to perform daily activities before surgery and were able to walk independently.
- Adults over 20
Key exclusion criteria (9 listed)
- Patients with history of previous open surgery
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 |
|---|---|---|
| ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation)When the abdominal wound is closed, the operator performs needle insertion at 14 sites near the incision site under the guidance of ultrasonography. When the needle is in the abdominal muscle, the operator performs muscle stimulation for about 10 seconds per needle insertion. | Procedure or surgery | ETOIMS arm, No ETOIMS arm |
Primary outcome
Pain: VAS (visual analogue scale)
Time frame: AM 7:00 morning at Preoperative day and the day following surgery before discharge (Postoperative day 1 - Postoperative day 10)
The primary outcome of this study was the postoperative pain score (VAS score) in patients undergoing ETOIMS during surgery. The type of surgery in the experimental group and the control group is the same and the same analgesic agent (IV PCA, Wound PCA) is used. The pain score is measured at 7 o'clock every morning from the day following surgery to discharge (about Postoperative day 10) to confirm the reduced pattern.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Derived from this study: PubMed 32623088Park J, Kim HS, Park JH, Park YG, Shin S, Park JE, Hwang S, Jun SY, Park JS. Effectiveness of Intramuscular Electrical Stimulation on Postsurgical Nociceptive Pain for Patients Undergoing Open Pancreaticoduodenectomy: A Randomized Clinical Trial. J Am Coll Surg. 2020 Sep;231(3):339-350. doi: 10.1016/j.jamcollsurg.2020.06.008. Epub 2020 Jul 2.
- Individual participant dataSharing planned: No
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 Phase 3 study testing ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation) in people with Disease Status of Pancreatobiliary Tract , ( Especially Who Need to Undergo Pancreaticoduodenectomy), run by Yonsei University at 1 site in South Korea.
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 9 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 7 Aug 2018. 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 South Korea. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain: VAS (visual analogue scale) (time frame: AM 7:00 morning at Preoperative day and the day following surgery before discharge (Postoperative day 1 - Postoperative day 10)). 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 NCT03619343, 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 7 Aug 2018.