Evaluaing the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Distal Radius Fracture

Postoperative Pain Relief Clinical Trial

Official title:

Single-blinded, Randomized Preliminary Study Evaluating the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Distal Radius Fracture.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04250974
• Other study ID #: CMUH108-REC1-140
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2019
• Est. completion date: November 28, 2020

Study information

• Verified date: February 2020
• Source: China Medical University Hospital
• Contact: Chiu-Ming Chang
• Phone: 886-982910198
• Email: asspiderman1982[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

1. EA group:EA at points after surgery

2. non-point group: EA at non-points after surgery

3. Control group: no EA

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

1. EA group:EA at points after surgery

2. non-point group: EA at non-points after surgery

3. 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:

1. true acupoints: needles were inserted to Taichong (LR3 ) and Taixi (KI3) contralateral to the operated leg and deqi sensation elicited at acupoints

2. 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:

1. Record the time required for the first injection of analgesics

2. The number of doses of oral painkiller used in 36 hours after surgery (count)

3. The number of doses of injection painkiller used in 36 hours after surgery (count)

4. Use the visual analog scale (VAS) to assess the patient's pain level

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 28, 2020
• Est. primary completion date: November 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain Relief
• Radius Fractures

Intervention

Other:
• electroacupuncture
acupuncture with electricity

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung	No. 2, Yude Rd, North District, Taichung City

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time required for the first injection of analgesics	Record the time required for the first injection of analgesics	in 36 hours after surgery
Primary	the number of doses of injection painkiller	Record the number of doses of injection painkiller	in 36 hours after surgery