NCT04189237

Brief Summary

Electroacupuncture improves pain and wrist functionality in patients undergoing rehabilitation therapy after 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. And, the postoperative goal is to restore the function of the forearm and the mobility of the wrist joint. Therefore, rehabilitation treatment is the key. However, postoperative patients often delay rehabilitation therapy due to pain, resulting in stiffer wrist joints. In recent years, electroacupuncture(EA) has been widely used to relieve pain after surgery, and many studies have confirmed that it is effective. And it is already an alternative to postoperative pain relief. The investigators hope that by electroacupuncture, the investigators can help patients reduce pain, increase joint mobility, and make patients willing to start rehabilitation therapy, reduce joint stiffness, and restore wrist function as soon as possible, which will help patients return to work and normal life early. Methods: It is expected that 30 patients will be randomly assigned to the following groups: electroacupuncture group, control group without EA. Two groups of subjects started to rehabilitation at the 4th week after surgery.

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

First Submitted

Initial submission to the registry

December 4, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

December 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
12 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

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

12 months

First QC Date

December 4, 2019

Last Update Submit

January 22, 2020

Conditions

Keywords

electroacupuncturewrist functionalitydistal radius fracture

Outcome Measures

Primary Outcomes (1)

  • Range of wrist motion

    The degrees of wrist mobility measured with a goniometer, including flexion, extension, supination, pronation, ulnar deviation, radial deviation, and higher degrees mean a better outcome.

    4 weeks

Secondary Outcomes (1)

  • Disabilities of the Arm, Shoulder and Hand(DASH)

    4 weeks

Study Arms (2)

electroacupuncture

EXPERIMENTAL

At the 4th week after surgery, electroacupuncture was performed, and the activity of wrist joint on the affected side was performed at same time, and at a frequency of two times per week for six weeks, for a total of twelve times. Acupoint selection: needles were inserted to Taixi (KI3), Taichong (LR3), Zusanli(ST36), Yanglingquan (GB34), contralateral to the operated leg and deqi sensation elicited at acupoints.

Other: Electroacupuncture

Control group

NO INTERVENTION

At the 4th week after surgery, only the activity of wrist joint on the affected side was performed, and at a frequency of two times per week for six weeks, for a total of twelve times.

Interventions

needles were inserted to Taixi (KI3), Taichong (LR3), Zusanli(ST36), Yanglingquan (GB34), contralateral to the operated leg and deqi sensation elicited at acupoints.

electroacupuncture

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of distal radius fracture
  • After internal fixation
  • Age between 20 and 70 years old

You may not qualify if:

  • serious heart rhythm
  • epilepsy
  • Severe pulmonary heart disease
  • History of mental illness
  • received acupuncture treatment 1 month ago

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

Conditions

Wrist Fractures

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

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

Study Design

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

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 6, 2019

Study Start

December 5, 2019

Primary Completion

November 28, 2020

Study Completion

November 28, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations