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

A New Treatment Modality for the Postoperative Muscular Pain Management in Pylorus Preserving Pancreaticoduodenectomy: a Double-blind Randomized Control Trial

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03619343
Enrollment
44
Registered
2018-08-07
Start date
2018-05-28
Completion date
2019-06-18
Last updated
2018-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease Status of Pancreatobiliary Tract , ( Especially Who Need to Undergo Pancreaticoduodenectomy)

Brief 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.

Interventions

PROCEDUREETOIMS(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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Control Intervention : ETOIMS apply group

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain: VAS (visual analogue scale)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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026