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

C

China Medical University

Status

Unknown

Conditions

Postoperative Pain Relief

Treatments

Other: electroacupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT04250974
CMUH108-REC1-140

Details and patient eligibility

About

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

Full 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

Enrollment

30 estimated patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 3 patient groups

electroacupuncture
Experimental group
Description:
electroacupuncture at points after surgery
Treatment:
Other: electroacupuncture
electroacupuncture non-point
Sham Comparator group
Description:
electroacupuncture at non-points after surgery
Treatment:
Other: electroacupuncture
Control group
No Intervention group
Description:
only oral or injection painkiller were used after surgery

Trial contacts and locations

1

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Central trial contact

Chiu-Ming Chang

Data sourced from clinicaltrials.gov

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