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

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

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

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain Relief
• Intervention / Treatment: Other: electroacupuncture

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

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • No. 2, Yude Rd, North District, Taichung City
    • Taichung, No. 2, Yude Rd, North District, Taichung City, Taiwan, 404
      • Recruiting
      • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: electroacupuncture; electroacupuncture at points after surgery	Other: electroacupuncture; acupuncture with electricity
Sham Comparator: electroacupuncture non-point; electroacupuncture at non-points after surgery	Other: electroacupuncture; acupuncture with electricity
No Intervention: Control group; only oral or injection painkiller were used after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the time required for the first injection of analgesics	Record the time required for the first injection of analgesics	in 36 hours after surgery
the number of doses of injection painkiller	Record the number of doses of injection painkiller	in 36 hours after surgery

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2019
• Primary Completion (Anticipated): November 28, 2020
• Study Completion (Anticipated): November 28, 2020

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Arm Injuries; Forearm Injuries; Pain, Postoperative; Radius Fractures
• Other Study ID Numbers: CMUH108-REC1-140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No