NCT04250974

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

12 months

First QC Date

January 22, 2020

Last Update Submit

February 13, 2020

Conditions

Postoperative Pain Relief

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

electroacupuncture

EXPERIMENTAL

electroacupuncture at points after surgery

Other: electroacupuncture

electroacupuncture non-point

SHAM COMPARATOR

electroacupuncture at non-points after surgery

Other: electroacupuncture

Control group

NO INTERVENTION

only oral or injection painkiller were used after surgery

Interventions

electroacupunctureOTHER

acupuncture with electricity

electroacupunctureelectroacupuncture non-point

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Orthopaedic specialist diagnoses distal radius fracture and undergoes internal fixation
  • Age between 20 and 70

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, No. 2, Yude Rd, North District, Taichung City, 404, Taiwan

RECRUITING

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Yung-Cheng Chiu, MD

    China Medical University Hospital

    STUDY DIRECTOR

Central Study Contacts

Chiu-Ming Chang

CONTACT

886-982910198asspiderman1982@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 31, 2020

Study Start

December 5, 2019

Primary Completion

November 28, 2020

Study Completion

November 28, 2020

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)