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

NCT ID: NCT04250974

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-05

Study Completion Date

2020-11-28

Brief Summary

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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

Detailed Description

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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

Conditions

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Postoperative Pain Relief

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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electroacupuncture

electroacupuncture at points after surgery

Group Type EXPERIMENTAL

electroacupuncture

Intervention Type OTHER

acupuncture with electricity

electroacupuncture non-point

electroacupuncture at non-points after surgery

Group Type SHAM_COMPARATOR

electroacupuncture

Intervention Type OTHER

acupuncture with electricity

Control group

only oral or injection painkiller were used after surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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electroacupuncture

acupuncture with electricity

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yung-Cheng Chiu, MD

Role: STUDY_DIRECTOR

China Medical University Hospital

Locations

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China Medical University Hospital

Taichung, No. 2, Yude Rd, North District, Taichung City, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chiu-Ming Chang

Role: CONTACT

886-982910198

Facility Contacts

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Chiu-Ming Chang

Role: primary

886-982910198

Other Identifiers

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CMUH108-REC1-140

Identifier Type: -

Identifier Source: org_study_id

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