Electroacupuncture Improves Pain and Wrist Functionality

Electroacupuncture Clinical Trial

Official title:

Electroacupuncture Improves Pain and Wrist Functionality in Patients Undergoing Rehabilitation Therapy After Arthroscopic Repair for Triangular Fibrocartilage Complex (TFCC) Tears.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04178265
• Other study ID #: CMUH108-REC2-057
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: May 5, 2020

Study information

• Verified date: December 2019
• Source: China Medical University Hospital
• Contact: Chiu-Ming Chang
• Phone: 886-982910198
• Email: asspiderman1982[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Triangular Fibrocartilage Complex (TFCC) is the main stable structure of the distal ulnar joint (DRUJ), and the damage of the triangular fibrocartilage complex is the most common cause of pain in the ulnar side of the wrist in the young athlete population. Once TFCC is injured, arthroscopic surgery is a common repair method. 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.

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.

1. Use the visual analog scale (VAS) to assess the patient's pain level

2. Use the Disabilities of the Arm, Shoulder and Hand(DASH) to assess the patient's pain and the inability.

3. The degrees of wrist mobility were measured.

4. Three time points were recorded: before the first electroacupuncture (4th week after surgery, when removing fixation), after the 6th, 12th (last) electroacupuncture.

5. Record the time point of the wrist joint recovery function and return to the workplace.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 5, 2020
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Orthopedic specialist diagnoses tearing of the triangular fibrocartilage complex and undergoes arthroscopic surgery

2. Age between 19 and 60 years old

Exclusion Criteria:

1. serious heart rhythm

2. epilepsy

3. Severe pulmonary heart disease

4. History of mental illness

5. received acupuncture treatment 1 month ago

Related Conditions & MeSH terms

• Electroacupuncture

Intervention

Other:
• Electroacupuncture
needles were inserted to Kunlun(BL60), Yanglingquan (GB34), Sanyinjiao(SP6), Taixi (KI 3) contralateral to the operated leg and deqi sensation elicited at acupoints.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung	No. 2, Yude Rd, North District, Taichung City

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	4 weeks