Integrated Traditional Chinese and Western Medicine for Patellar Dislocation Pain: A Concurrent Non-Randomized Controlled Trial
22 de maio de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ativo, não recrutando
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
80
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100191
- Peking University Third Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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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.
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Comparador Ativo: 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.
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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VAS
Prazo: Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30, and at 3 months.
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0-10, with 0 representing no pain and 10 representing the most severe pain
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Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30, and at 3 months.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Lysholm Knee Function Score
Prazo: 3 months after surgery
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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.
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3 months after surgery
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Tegner Activity Scale
Prazo: 3 months after surgery
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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.
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3 months after surgery
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International Knee Documentation Committee (IKDC)-2000
Prazo: 3 months after surgery
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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
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sleep score
Prazo: Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30.
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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.
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Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30.
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Joint swelling
Prazo: Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30.
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Measure the leg circumference 5 cm above the superior border of the patella using a soft tape measure.
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Preoperative, immediately before and after acupuncture, and then at postoperative day 3, day 4, day 7, day 14, day 30.
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Adverse events
Prazo: postoperatively at 3 days, 4 days, 14 days, 30 days, and 3 months.
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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.
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postoperatively at 3 days, 4 days, 14 days, 30 days, and 3 months.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de junho de 2024
Conclusão Primária (Estimado)
30 de junho de 2026
Conclusão do estudo (Estimado)
30 de junho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
22 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de maio de 2026
Primeira postagem (Real)
29 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- M2024595
- 2404-01-19 (Número de outro subsídio/financiamento: Peking University Third Hospital)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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