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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03619343
• Other study ID #: 3-2018-0100
• Status: Recruiting
• Phase: Phase 3
• Start date: May 28, 2018
• Est. completion date: June 18, 2019

Study information

• Verified date: August 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: June 18, 2019
• Est. primary completion date: February 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	GangnamSeverance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	AM 7:00 morning at Preoperative day and the day following surgery before discharge (Postoperative day 1 - Postoperative day 10)