- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04178265
Electroacupuncture Improves Pain and Wrist Functionality
Electroacupuncture Improves Pain and Wrist Functionality in Patients Undergoing Rehabilitation Therapy After Arthroscopic Repair for Triangular Fibrocartilage Complex (TFCC) Tears.
Study Overview
Detailed Description
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 therapy at a hospital or clinic 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 three times per week for four 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 three times per week for four weeks, for a total of twelve times.
Acupoint selection: needles were inserted to Kunlun(BL60), Yanglingquan (GB34), Sanyinjiao(SP6), Taixi (KI 3) 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(DASH) to assess the patient's pain and the inability.
- 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.
- Record the time point of the wrist joint recovery function and return to the workplace.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
No. 2, Yude Rd, North District, Taichung City
-
Taichung, No. 2, Yude Rd, North District, Taichung City, Taiwan, 404
- Recruiting
- China Medical University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Orthopedic specialist diagnoses tearing of the triangular fibrocartilage complex and undergoes arthroscopic surgery
- Age between 19 and 60 years old
Exclusion Criteria:
- serious heart rhythm
- epilepsy
- Severe pulmonary heart disease
- History of mental illness
- received acupuncture treatment 1 month ago
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 three times per week for four weeks, for a total of twelve times. Acupoint selection: needles were inserted to Kunlun(BL60), Yanglingquan (GB34), Sanyinjiao(SP6), Taixi (KI 3) contralateral to the operated leg and deqi sensation elicited at acupoints. |
needles were inserted to Kunlun(BL60), Yanglingquan (GB34), Sanyinjiao(SP6), Taixi (KI 3) contralateral to the operated leg and deqi sensation elicited at acupoints.
|
No Intervention: 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 three times per week for four weeks, for a total of twelve times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of wrist motion
Time Frame: 4 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disabilities of the Arm, Shoulder and Hand(DASH)
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CMUH108-REC2-057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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