NCT04178265

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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2020

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

November 7, 2019

Last Update Submit

December 10, 2019

Conditions

Keywords

electroacupuncturetriangular fibrocartilage complex tearsTFCC tearspainwrist functionality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Disabilities of the Arm, Shoulder and Hand(DASH)

    4 weeks

Study Arms (2)

Electroacupuncture group

EXPERIMENTAL

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.

Other: Electroacupuncture

Control group

NO INTERVENTION

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.

Interventions

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

Electroacupuncture group

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Orthopedic specialist diagnoses tearing of the triangular fibrocartilage complex and undergoes arthroscopic surgery
  • Age between 19 and 60 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, No. 2, Yude Rd, North District, Taichung City, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Yung-Cheng Chiu, MD

    China Medical University Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2019

First Posted

November 26, 2019

Study Start

May 6, 2019

Primary Completion

May 5, 2020

Study Completion

May 5, 2020

Last Updated

December 12, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations