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

Single-blinded, Randomized Preliminary Study Evaluating the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Arthroscopic Repair for Triangular Fibrocartilage Complex (TFCC) Tears

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

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain Relief
• Intervention / Treatment: Other: electroacupuncture

Detailed Description

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. electroacupuncture group(EAG): EA at points after surgery
2. non-point group (NPG): EA at non-points after surgery

Mode of operation: After the patient has returned to the recovery room, take the needle after 30 minutes, and then statistics.

Acupoint selection:

1. true acupoints: needles were inserted to Kunlun(BL60) and Sanyinjiao(SP6) contralateral to the operated leg and deqi sensation elicited at acupoints
2. false point: the needles were inserted to Zusanli(ST36) and Shangjuxu(ST37) contralateral to the operated leg and deqi sensation elicited at acupoints
3. Control group:only injection and oral painkiller were used before surgery

Data collection:

1. Record the time required for the first injection of analgesics
2. The number of doses of injection painkiller used in 36 hours after surgery (count)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • 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: 19 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: electroacupuncture; electroacupuncture at points after surgery	Other: electroacupuncture; acupuncture with electricity
SHAM_COMPARATOR: electroacupuncture non-point; electroacupuncture at non-points after surgery	Other: electroacupuncture; acupuncture with electricity
NO_INTERVENTION: Control group; only injection painkiller were used before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ANTICIPATED): April 30, 2020
• Study Completion (ANTICIPATED): April 30, 2020

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (ACTUAL): November 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: CMUH108-REC1-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No