A Study Evaluates the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Repair for TFCC Tears
Primary Purpose
Postoperative Pain Relief
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
electroacupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain Relief
Eligibility Criteria
Inclusion Criteria:
- Orthopaedic specialist diagnoses tearing of the triangular fibrocartilage complex and undergoes arthroscopic repair
- Age between 19 and 60
Exclusion Criteria:
- Allergic to painkillers
- Have a serious heart rhythm
- epilepsy
- Severe pulmonary heart disease
- History of mental illness
- History of drug abuse
- received acupuncture treatment within 1 month
Sites / Locations
- China Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
electroacupuncture
electroacupuncture non-point
Control group
Arm Description
electroacupuncture at points after surgery
electroacupuncture at non-points after surgery
only injection painkiller were used before surgery
Outcomes
Primary Outcome Measures
the effect of pain relief
Record the time required for the first injection of analgesics and the number of doses of oral painkiller and injection painkiller
Secondary Outcome Measures
Full Information
NCT ID
NCT04157543
First Posted
April 22, 2019
Last Updated
March 10, 2020
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04157543
Brief Title
A Study Evaluates the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Repair for TFCC Tears
Official Title
Single-blinded, Randomized Preliminary Study Evaluating the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Arthroscopic Repair for Triangular Fibrocartilage Complex (TFCC) Tears
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Triangular Fibrocartilage Complex (TFCC) is the main stable structure of the distal ulnar joint (DRUJ), and the damage of the triangular fibrocartilage complex is the most common cause of pain in the ulnar side of the wrist in the young athlete population. Once TFCC is injured, arthroscopic surgery is a common repair method. The postoperative analgesic method is generally oral or injection analgesic. In recent years, electroacupuncture(EA) has been widely used to relieve pain after surgery, and many studies have confirmed that it is effective. However, there is no evaluation of analgesic efficacy after arthroscopic repair of the TFCC. Therefore, it is hoped that the efficacy of electroacupuncture for analgesia after arthroscopic repair of the TFCC is demonstrated by this study. And, the investigators also hope the investigators can reduce the use of painkillers through electroacupuncture.
Methods:It is expected that 30 patients will be randomly assigned to the following groups: electroacupuncture group(EAG), EA at points; non-point group (NPG), EA at non-points, control group (CG) without EA
electroacupuncture group(EAG): EA at points after surgery
non-point group (NPG): EA at non-points after surgery
Control group: only injection painkiller were used before surgery
Detailed Description
Triangular Fibrocartilage Complex (TFCC) is the main stable structure of the distal ulnar joint (DRUJ), and the damage of the triangular fibrocartilage complex is the most common cause of pain in the ulnar side of the wrist in the young athlete population. Once TFCC is injured, arthroscopic surgery is a common repair method. The postoperative analgesic method is generally oral or injection analgesic. In recent years, electroacupuncture(EA) has been widely used to relieve pain after surgery, and many studies have confirmed that it is effective. However, there is no evaluation of analgesic efficacy after arthroscopic repair of the TFCC. Therefore, it is hoped that the efficacy of electroacupuncture for analgesia after arthroscopic repair of the TFCC is demonstrated by this study. And, the investigators also hope the investigators can reduce the use of painkillers through electroacupuncture.
Methods:
It is expected that 30 patients will be randomly assigned to the following groups: electroacupuncture group(EAG), EA at points; non-point group (NPG), EA at non-points, control group (CG) without EA
electroacupuncture group(EAG): EA at points after surgery
non-point group (NPG): EA at non-points after surgery
Mode of operation: After the patient has returned to the recovery room, take the needle after 30 minutes, and then statistics.
Acupoint selection:
true acupoints: needles were inserted to Kunlun(BL60) and Sanyinjiao(SP6) contralateral to the operated leg and deqi sensation elicited at acupoints
false point: the needles were inserted to Zusanli(ST36) and Shangjuxu(ST37) contralateral to the operated leg and deqi sensation elicited at acupoints
Control group:only injection and oral painkiller were used before surgery
Data collection:
Record the time required for the first injection of analgesics
The number of doses of injection painkiller used in 36 hours after surgery (count)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Relief
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
electroacupuncture
Arm Type
Experimental
Arm Description
electroacupuncture at points after surgery
Arm Title
electroacupuncture non-point
Arm Type
Sham Comparator
Arm Description
electroacupuncture at non-points after surgery
Arm Title
Control group
Arm Type
No Intervention
Arm Description
only injection painkiller were used before surgery
Intervention Type
Other
Intervention Name(s)
electroacupuncture
Intervention Description
acupuncture with electricity
Primary Outcome Measure Information:
Title
the effect of pain relief
Description
Record the time required for the first injection of analgesics and the number of doses of oral painkiller and injection painkiller
Time Frame
in 36 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Orthopaedic specialist diagnoses tearing of the triangular fibrocartilage complex and undergoes arthroscopic repair
Age between 19 and 60
Exclusion Criteria:
Allergic to painkillers
Have a serious heart rhythm
epilepsy
Severe pulmonary heart disease
History of mental illness
History of drug abuse
received acupuncture treatment within 1 month
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chiu-Ming Chang
Phone
886-982910198
Email
asspiderman1982@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Cheng Chiu, MD
Organizational Affiliation
China Medical University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
State/Province
No. 2, Yude Rd, North District, Taichung City
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiu-Ming Chang
Phone
886-982910198
Email
asspiderman1982@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study Evaluates the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Repair for TFCC Tears
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