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

Yonsei University

Status and phase: Unknown; Phase 3

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

Treatments: Procedure: ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT03619343

3-2018-0100

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

No ETOIMS arm

Experimental group

Description:

When the abdominal wound is closed, the operator performs needle insertion at 14 sites near the incision site under the guidance of ultrasonography.

Treatment:

Procedure: ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation)

ETOIMS arm

Active Comparator group

Description:

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.

Treatment:

Procedure: ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation)