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Electroacupuncture Improves Wrist Functionality and Pain

Primary Purpose

Electroacupuncture

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Electroacupuncture
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Electroacupuncture focused on measuring electroacupuncture, wrist functionality, distal radius fracture

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

electroacupuncture

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Disabilities of the Arm, Shoulder and Hand(DASH)
Assess the patient's pain and the inability, the DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.

Full Information

First Posted
December 4, 2019
Last Updated
January 22, 2020
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04189237
Brief Title
Electroacupuncture Improves Wrist Functionality and Pain
Official Title
Electroacupuncture Improves Pain and Wrist Functionality in Patients Undergoing Rehabilitation Therapy After Distal Radius Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
November 28, 2020 (Anticipated)
Study Completion Date
November 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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. Mode of operation: Electroacupuncture group: 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. Control group: 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. 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. Data collection: The evaluator does not know the patient group to achieve a single blind effect. Use the visual analog scale (VAS) to assess the patient's pain level Use the Disabilities of the Arm, Shoulder and Hand questionnaire(DASH) to assess the patient's pain and the functionality. The degrees of wrist mobility were measured. Three time points were recorded: before the first electroacupuncture (4th week after surgery, when removing fixation), after the 6th, 12th (last) electroacupuncture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electroacupuncture
Keywords
electroacupuncture, wrist functionality, distal radius fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
electroacupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Electroacupuncture
Intervention Description
needles were inserted to Taixi (KI3), Taichong (LR3), Zusanli(ST36), Yanglingquan (GB34), contralateral to the operated leg and deqi sensation elicited at acupoints.
Primary Outcome Measure Information:
Title
Range of wrist motion
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand(DASH)
Description
Assess the patient's pain and the inability, the DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of distal radius fracture After internal fixation Age between 20 and 70 years old Exclusion Criteria: serious heart rhythm epilepsy Severe pulmonary heart disease History of mental illness received acupuncture treatment 1 month ago
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chiu-Ming Chang
Phone
886-982910198
Email
asspiderman1982@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Cheng Chiu, MD
Organizational Affiliation
China Medical University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
State/Province
No. 2, Yude Rd, North District, Taichung City
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiu-Ming Chang
Phone
886-982910198
Email
asspiderman1982@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Electroacupuncture Improves Wrist Functionality and Pain

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