Back to resultsPostoperative Muscular Pain, ETOIMS (Electrical Twitch Obstructive Intramuscular Stimulation)
Primary Purpose
Disease Status of Pancreatobiliary Tract , ( Especially Who Need to Undergo Pancreaticoduodenectomy)
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation)
Sponsored by
About this trial
This is an interventional treatment trial for Disease Status of Pancreatobiliary Tract , ( Especially Who Need to Undergo Pancreaticoduodenectomy)
Eligibility Criteria
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
Sites / Locations
- GangnamSeverance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
No ETOIMS arm
ETOIMS arm
Arm 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 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03619343
Brief Title
Postoperative Muscular Pain, ETOIMS (Electrical Twitch Obstructive Intramuscular Stimulation)
Official Title
A New Treatment Modality for the Postoperative Muscular Pain Management in Pylorus Preserving Pancreaticoduodenectomy: a Double-blind Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 28, 2018 (Actual)
Primary Completion Date
February 18, 2019 (Anticipated)
Study Completion Date
June 18, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disease Status of Pancreatobiliary Tract , ( Especially Who Need to Undergo Pancreaticoduodenectomy)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Control Intervention : ETOIMS apply group
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No ETOIMS arm
Arm Type
Experimental
Arm Description
When the abdominal wound is closed, the operator performs needle insertion at 14 sites near the incision site under the guidance of ultrasonography.
Arm Title
ETOIMS arm
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation)
Intervention 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.
Primary Outcome Measure Information:
Title
Pain: VAS (visual analogue scale)
Description
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.
Time Frame
AM 7:00 morning at Preoperative day and the day following surgery before discharge (Postoperative day 1 - Postoperative day 10)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
GangnamSeverance Hospital
City
Seoul
ZIP/Postal Code
00000
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon Seong Park
Phone
82-2-2019-3375
Email
JSPARK330@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32623088
Citation
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.
Results Reference
derived
Learn more about this trial
Postoperative Muscular Pain, ETOIMS (Electrical Twitch Obstructive Intramuscular Stimulation)
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