A Study Evaluates the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Repair for TFCC Tears

NCT04157543 | Unknown

• 1 other identifier: CMUH108-REC1-035
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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 arthroscopic repair of the TFCC. Therefore, it is hoped that the efficacy of electroacupuncture for analgesia after arthroscopic repair of the TFCC is demonstrated by this study. And, the investigators also hope the investigators can reduce the use of painkillers through electroacupuncture. Methods:It is expected that 30 patients will be randomly assigned to the following groups: electroacupuncture group(EAG), EA at points; non-point group (NPG), EA at non-points, control group (CG) without EA

1. 1.electroacupuncture group(EAG): EA at points after surgery
2. 2.non-point group (NPG): EA at non-points after surgery
3. 3.Control group: only injection painkiller were used before surgery

Conditions

Postoperative Pain Relief

Outcome Measures

Primary Outcomes (1)

• the effect of pain relief

  Record the time required for the first injection of analgesics and the number of doses of oral painkiller and 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 injection painkiller were used before surgery

Interventions

electroacupuncture OTHER

acupuncture with electricity

electroacupuncture; electroacupuncture non-point

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Orthopaedic specialist diagnoses tearing of the triangular fibrocartilage complex and undergoes arthroscopic repair
• Age between 19 and 60

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

Sponsors & Collaborators

• China Medical University Hospital: lead

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 Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Yung-Cheng Chiu, MD

  China Medical University Hospital

  STUDY DIRECTOR

Central Study Contacts

Chiu-Ming Chang

CONTACT

886-982910198; asspiderman1982@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: April 22, 2019
• First Posted: November 8, 2019
• Study Start: May 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)