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

May 22, 2026 updated by: Liu Zhenlong, Peking University Third Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Acupuncture group
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
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.
Active Comparator: Pharmacological group
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
Drug therapy refers to oral or topical medication, specifically oral Voltaren sustained-release tablets at a dose of 0.5 mg/kg twice daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30, and at 3 months.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lysholm Knee Function Score
Time Frame: 3 months after surgery
It can assess specific symptoms and functional impairments of the knee joint, and has particular advantages in reflecting instability and limitations in daily activities. It consists of 8 items, with a total score of 100. The higher the score, the better the function. Function classification (widely accepted standard): Excellent: 95 - 100 points; Good: 84 - 94 points; Average: 65 - 83 points; Poor: < 65 points.
3 months after surgery
Tegner Activity Scale
Time Frame: 3 months after surgery
It is a one-dimensional scale ranging from 0 to 10, used to assess the activity level of patients in terms of sports and daily work. The higher the score, the higher the activity level of knee joint. High score (8-10 points): Indicates the level of competitive sports, with extremely high requirements for the knee joint. Medium score (4-7 points): Represents recreational sports and physical labor, which is the level of most active people. Low score (0-3 points): Represents daily life and sedentary work, with a lower load on the knee joint.
3 months after surgery
International Knee Documentation Committee (IKDC)-2000
Time Frame: 3 months after surgery

It can comprehensively assess the knee joint's functionality, consisting of 18 questions, covering three dimensions:

symptoms, sports activity function, and daily activity function. The higher the score, the better the knee joint's functionality and the fewer the symptoms. Generally, a score of >90 indicates excellent function, while a score of <70 indicates significant functional impairment. The minimum clinically important difference is approximately 10-12 points.
3 months after surgery
sleep score
Time Frame: Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30.
The sleep score ranging from 1 to 5 was used to assess sleep quality, with 1 indicating very good sleep and 5 indicating inability to fall asleep.
Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Joint swelling
Time Frame: Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30.
Measure the leg circumference 5 cm above the superior border of the patella using a soft tape measure.
Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30.
Adverse events
Time Frame: postoperatively at 3 days, 4 days, 14 days, 30 days, and 3 months.
This study will systematically monitor and record all adverse events and serious adverse events that occur from the start of treatment until the last follow-up. Adverse events refer to any adverse medical events that occur in patients after receiving treatment. These include, but are not limited to, common complications related to surgery, recurrent dislocation, impaired mobility, etc.
postoperatively at 3 days, 4 days, 14 days, 30 days, and 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2024595
  • 2404-01-19 (Other Grant/Funding Number: Peking University Third Hospital)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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