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

Peking University

Status: Active, not recruiting

Conditions: Postoperative Pain After Patellar Dislocation Surgery

Treatments: Procedure: Acupuncture; Drug: Voltaren

Study type: Interventional

Funder types: Other

Identifiers

NCT07613346

2404-01-19 (Other Grant/Funding Number)

M2024595

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with recurrent patellar dislocation, male or female;
• patients with acute patellar dislocation complicated by a tangential osteochondral fracture requiring surgical treatment;
• patients who voluntarily participated in the clinical trial, signed the informed consent form, and were able to comply with clinical follow-up;

Exclusion criteria

• participation in other drug or medical device clinical trials within the past 6 months;
• joint fibrosis, ankylosis, or significant limitation of movement;
• contraindications to MRI examination;
• other conditions that, in the physician's judgment, preclude participation in the trial.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Acupuncture group

Experimental group

Description:

Patients received basic treatment (rest, elevation, ice therapy 20 min 6 times daily, extension brace for 4 weeks) and rehabilitation (supine straight leg raise 30 min daily, wall squats 30 min daily, medial quadriceps strengthening every other day). In addition, they received traditional Chinese acupuncture at LI11 and SI4 on the day of surgery and the day after surgery.

Treatment:

Procedure: Acupuncture

Pharmacological group

Active Comparator group

Description:

Patients received the same basic treatment and rehabilitation as the acupuncture group. In addition, they received oral Voltaren sustained-release tablets (diclofenac) at 0.5 mg/kg twice daily.

Treatment:

Drug: Voltaren