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Integrated Traditional Chinese and Western Medicine for Patellar Dislocation Pain: A Concurrent Non-Randomized Controlled Trial

NCT07613346 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-29

No results posted yet for this study

Summary

This study is a concurrent non-randomized controlled pilot trial. We plan to recruit 80 patients following patellar dislocation surgery from Peking University Third Hospital in China, with at least 40 participants in each group. The study aims to evaluate the safety and efficacy of acupuncture for the treatment of postoperative pain after patellar dislocation. The treatment regimen (pharmacological therapy or acupuncture) will be determined by the clinician and the patient based on the patient's condition and preference.

Participants will be assigned to two groups according to the treatment they receive in clinical practice: a medication group and an acupuncture group. All participants will enter a follow-up phase lasting up to 3 months.

Assessments include pain intensity (Visual Analog Scale, VAS), the Lysholm Knee Score, the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, the Tegner Activity Score, a sleep score, and the degree of joint swelling. VAS pain score, sleep score, and joint swelling will be evaluated preoperatively and on postoperative days 3, 4, 7, 14, 30, and at 3 months. The remaining outcomes will be measured at 3 months postoperatively.

Conditions

  • Postoperative Pain After Patellar Dislocation Surgery

Interventions

PROCEDURE

Acupuncture

The acupuncture points for Traditional Chinese Medicine (TCM) treatment are Quchi (LI11) and Zhisi Ma (SI4). For Quchi, the needle is inserted at the point of marked tenderness around the Quchi point on the contralateral Hand Yangming Large Intestine Meridian. For Zhisi Ma, the needle is inserted at the junction of red and white skin on the back of the hand, penetrating to the subcutaneous tissue on the palm side. Needling is manipulated every 15 minutes, while the patient is guided to gently move the affected knee joint, with the needles retained for 45 minutes. Treatment is performed once on the day of surgery and once on the day following surgery.

DRUG

Voltaren

Drug therapy refers to oral or topical medication, specifically oral Voltaren sustained-release tablets at a dose of 0.5 mg/kg twice daily.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07613346 on ClinicalTrials.gov