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

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ClinicalTrials.gov Identifier: NCT04250974
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

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

  1. EA group:EA at points after surgery
  2. non-point group: EA at non-points after surgery
  3. Control group: no EA

Condition or disease Intervention/treatment Phase
Postoperative Pain Relief Other: electroacupuncture Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Single-blinded, Randomized Preliminary Study Evaluating the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Distal Radius Fracture.
Actual Study Start Date : December 5, 2019
Estimated Primary Completion Date : November 28, 2020
Estimated Study Completion Date : November 28, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. the time required for the first injection of analgesics [ Time Frame: in 36 hours after surgery ]
    Record the time required for the first injection of analgesics

  2. the number of doses of injection painkiller [ Time Frame: in 36 hours after surgery ]
    Record the number of doses of injection painkiller



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250974


Contacts
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Contact: Chiu-Ming Chang 886-982910198 asspiderman1982@gmail.com

Locations
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Taiwan
China Medical University Hospital Recruiting
Taichung, No. 2, Yude Rd, North District, Taichung City, Taiwan, 404
Contact: Chiu-Ming Chang    886-982910198    asspiderman1982@gmail.com   
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Study Director: Yung-Cheng Chiu, MD China Medical University Hospital
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04250974    
Other Study ID Numbers: CMUH108-REC1-140
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Radius Fractures
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Forearm Injuries
Arm Injuries
Wounds and Injuries
Fractures, Bone