Integrated Traditional Chinese and Western Medicine for Patellar Dislocation Pain: A Concurrent Non-Randomized Controlled Trial
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.
調査の概要
状態
介入・治療
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100191
- Peking University Third Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
アクティブコンパレータ：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 therapy refers to oral or topical medication, specifically oral Voltaren sustained-release tablets at a dose of 0.5 mg/kg twice daily.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
VAS
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Lysholm Knee Function Score
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Joint swelling
時間枠：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
時間枠：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.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- M2024595
- 2404-01-19 (その他の助成金/資金番号：Peking University Third Hospital)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Acupunctureの臨床試験
-
Guang'anmen Hospital of China Academy of Chinese...募集
-
Northern Jiangsu People's Hospital募集
-
Kong Fanming募集
-
Yuanyuan WuJiaxing Traditional Chinese Medicine Hospital; Pingyang County Traditional Chinese Medicine...まだ募集していません
-
Kong FanmingMinistry of Science and Technology of the People´s Republic of China募集非小細胞肺がん | 免疫チェックポイント阻害剤 | 電気鍼中国