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| ID | Type | Description | Link |
|---|---|---|---|
| 2404-01-19 | Other Grant/Funding Number | Peking University Third Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Joint swelling | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
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| 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. |
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| 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. | 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. | 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. | Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30. |
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. |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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