Postoperative Pain After Patellar Dislocation SurgeryNCT07613346
Integrated Traditional Chinese and Western Medicine for Patellar Dislocation Pain: A Concurrent Non-Randomized Controlled Trial
A study testing Acupuncture and Voltaren in people with Postoperative Pain After Patellar Dislocation Surgery, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain After Patellar Dislocation Surgery
- What is being tested?
- Acupuncture and Voltaren
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: 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.
- Being tested
- Acupuncture, Voltaren
- Keywords
- Treatment of postoperative pain after patellar dislocation surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
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.
VoltarenDrug
Drug therapy refers to oral or topical medication, specifically oral Voltaren sustained-release tablets at a dose of 0.5 mg/kg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Voltaren |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
0-10, with 0 representing no pain and 10 representing the most severe pain
Measured: 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
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.
Measured: 3 months after surgery
Tegner Activity Scale
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.
Measured: 3 months after surgery
International Knee Documentation Committee (IKDC)-2000
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.
Measured: 3 months after surgery
sleep score
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.
Measured: Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Aug 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain After Patellar Dislocation SurgeryStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhenlong, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613346
- Sponsor's protocol ID
- M2024595
- Other IDs
- 2404-01-19
- Status last verified
- Oct 2026
- First submitted
- 22 May 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Concurrent Non-Randomized Controlled Trial on Integrated Traditional Chinese and Western Medicine for Patellar Dislocation Pain
- ClinicalTrials.gov ID
- NCT07613346
- Acronym / sponsor ID
- M2024595
- Keywords
- Treatment of postoperative pain after patellar dislocation surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Procedure: AcupuncturePatients 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. |
| Pharmacological group | Active comparator | Drug: VoltarenPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureThe 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. | Procedure or surgery | Acupuncture group |
| VoltarenDrug therapy refers to oral or topical medication, specifically oral Voltaren sustained-release tablets at a dose of 0.5 mg/kg twice daily. | Drug | Pharmacological group |
Primary outcome
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
4 secondary outcomes
Lysholm Knee Function Score
Time frame: 3 months after surgery
Tegner Activity Scale
Time frame: 3 months after surgery
International Knee Documentation Committee (IKDC)-2000
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Voltaren in people with Postoperative Pain After Patellar Dislocation Surgery, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.