UnknownPhase 3

Postoperative Muscular Pain, ETOIMS (Electrical Twitch Obstructive Intramuscular Stimulation)

South Korea44 participantsStarted 2018-05-28

Plain-language 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. 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.

Who can participate

Age range

20 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Patients who have cognitive impairment and can not answer the questionnaire * Patients with Pacemaker * Patients who can not read the consent form

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain: VAS (visual analogue scale)

Timeframe: AM 7:00 morning at Preoperative day and the day following surgery before discharge (Postoperative day 1 - Postoperative day 10)

Trial details

NCT IDNCT03619343

SponsorYonsei University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02-18

View on ClinicalTrials.gov More Disease Status of Pancreatobiliary Tract , ( Especially Who Need to Undergo Pancreaticoduodenectomy) trials