Evaluaing the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Distal Radius Fracture
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 distal radius fracture and undergoes internal fixation
- Age between 20 and 70
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 oral or injection painkiller were used after surgery
Outcomes
Primary Outcome Measures
the time required for the first injection of analgesics
Record the time required for the first injection of analgesics
the number of doses of injection painkiller
Record the number of doses of injection painkiller
Secondary Outcome Measures
Full Information
NCT ID
NCT04250974
First Posted
January 22, 2020
Last Updated
February 13, 2020
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04250974
Brief Title
Evaluaing the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Distal Radius Fracture
Official Title
Single-blinded, Randomized Preliminary Study Evaluating the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Distal Radius Fracture.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
November 28, 2020 (Anticipated)
Study Completion Date
November 28, 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
Single-blinded, randomized preliminary study evaluating the effects of electroacupuncture for postoperative pain relief in patients with distal radius fracture.
Distal radius fracture is extremely common, and it is about 10% of all fractures in the human body. Therefore, the distal radius is the most frequently fractured part of the upper limbs of the human body. Once the fracture occurs, internal fixation is the main surgical procedure. 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 the surgery of distal radius fracture. Therefore, it is hoped that the efficacy of EA for analgesia after the surgery of distal radius fracture is demonstrated by this study. And, the investigators also hope the investigators can reduce the use of painkillers through EA.
Methods: It is expected that 30 patients will be randomly assigned to the following groups: EA group,EA at points; non-point group, EA at non-points, control group without EA
EA group:EA at points after surgery
non-point group: EA at non-points after surgery
Control group: no EA
Detailed Description
Single-blinded, randomized preliminary study evaluating the effects of electroacupuncture for postoperative pain relief in patients with distal radius fracture.
Distal radius fracture is extremely common, and it is about 10% of all fractures in the human body. Therefore, the distal radius is the most frequently fractured part of the upper limbs of the human body. Once the fracture occurs, internal fixation is the main surgical procedure. 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 the surgery of distal radius fracture. Therefore, it is hoped that the efficacy of EA for analgesia after the surgery of distal radius fracture is demonstrated by this study. And, the investigators also hope the investigators can reduce the use of painkillers through EA.
Methods: It is expected that 30 patients will be randomly assigned to the following groups: EA group,EA at points; non-point group, EA at non-points, control group without EA
EA group:EA at points after surgery
non-point group: EA at non-points after surgery
Control group: no EA Mode of operation: After the patient has returned to the recovery room, perfom EA, and take the needle after 30 minutes. Perform another 30 minutes after 24 hours, and then statistics.
Acupoint selection:
true acupoints: needles were inserted to Taichong (LR3 ) and Taixi (KI3) contralateral to the operated leg and deqi sensation elicited at acupoints
false point: the needles were inserted to Kunlun(BL60) and Shugu(BL65) contralateral to the operated leg and deqi sensation elicited at acupoints
Data collection:
Record the time required for the first injection of analgesics
The number of doses of oral painkiller used in 36 hours after surgery (count)
The number of doses of injection painkiller used in 36 hours after surgery (count)
Use the visual analog scale (VAS) to assess the patient's pain level
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 oral or injection painkiller were used after surgery
Intervention Type
Other
Intervention Name(s)
electroacupuncture
Intervention Description
acupuncture with electricity
Primary Outcome Measure Information:
Title
the time required for the first injection of analgesics
Description
Record the time required for the first injection of analgesics
Time Frame
in 36 hours after surgery
Title
the number of doses of injection painkiller
Description
Record the number of doses of injection painkiller
Time Frame
in 36 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Orthopaedic specialist diagnoses distal radius fracture and undergoes internal fixation
Age between 20 and 70
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
Evaluaing the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Distal Radius Fracture
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