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

NCT07613346 | Active Not Recruiting DMC

• 2 other identifiers: M20245952404-01-19
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Treatment of postoperative pain after patellar dislocation surgery

Outcome Measures

Primary Outcomes (1)

• VAS

  0-10, with 0 representing no pain and 10 representing the most severe pain

  Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30, and at 3 months.

Secondary Outcomes (4)

• Lysholm Knee Function Score

  3 months after surgery

• Tegner Activity Scale

  3 months after surgery

• International Knee Documentation Committee (IKDC)-2000

  3 months after surgery

• sleep score

  Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30.

Other Outcomes (2)

• Joint swelling

  Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30.

• Adverse events

  postoperatively at 3 days, 4 days, 14 days, 30 days, and 3 months.

Study Arms (2)

Acupuncture group

EXPERIMENTAL

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.

Procedure: Acupuncture

Pharmacological group

ACTIVE COMPARATOR

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.

Drug: Voltaren

Interventions

Acupuncture PROCEDURE

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.

Acupuncture group

Voltaren DRUG

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

Pharmacological group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Interventions

Acupuncture Therapy; Diclofenac

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)