Clinical Effects of Moxibustion Combined With Tailored Baduanjin Exercise Programs on Early Postoperative Rehabilitation in Lumbar Disc Herniation Patients Undergoing Minimally Invasive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Japanese Orthopaedic Society,JOA
研究概览
简要总结
This study is a single-center randomized controlled trial, aiming to explore the effect of moxibustion combined with the modified Baduanjin exercise regimen on the early rehabilitation of patients with lumbar disc herniation (LDH) after minimally invasive surgery. A total of 120 patients were included in the study and randomly divided into the control group (conventional treatment and rehabilitation care), the Baduanjin group (conventional treatment + modified Baduanjin), and the combined intervention group (conventional treatment + Baduanjin + moxibustion). By comparing the visual pain scores (VAS), lumbar function scores (JOA), lumbar range of motion, and anxiety scale (HAMA) changes at 1 day, 1 month, and 3 months after surgery, the study evaluated the improvement effect of the integrated traditional Chinese medicine and Western medicine rehabilitation plan on postoperative pain relief, functional recovery, and psychological state. The study innovatively integrates the advantages of traditional Chinese medicine moxibustion for warming and promoting meridians and the low-intensity exercise of the modified Baduanjin, optimizes the difficulty of traditional rehabilitation training, and provides evidence-based basis for improving patient compliance and standardizing postoperative rehabilitation programs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •① Refer to the diagnostic criteria for LDH in the "Diagnosis and Treatment Guidelines for Lumbar Intervertebral Disc Protrusion (2020 Edition)";
- •Age > 18 years old; ③ Patients who have not responded to conservative treatment and have undergone minimally invasive surgery for lumbar intervertebral disc protrusion in our hospital, including percutaneous puncture interventional procedures (percutaneous intervertebral disc aspiration, percutaneous intervertebral disc laser ablation, percutaneous intervertebral disc ozone ablation, and radiofrequency nucleus removal and formation), micro-lumbar intervertebral disc resection, micro-endoscopic lumbar intervertebral disc resection, and percutaneous endoscopic lumbar intervertebral disc resection; ④ Participants who voluntarily participate in this study.
排除标准
- •① Previous history of lumbar surgery;
- •Those with severe spinal canal stenosis or other severe deformities;
- •Patients with bleeding tendencies or hematological diseases; ④ Patients with mental disorders and cognitive impairments; ⑤ Patients allergic to the drugs used in the study; ⑥ Patients with severe primary diseases (such as tuberculosis, tumors and mental disorders), or those with postoperative lumbar infections.
结局指标
主要结局
Japanese Orthopaedic Society,JOA
时间窗: The 1st day after the operation, 1 month after the operation, 3 months after the operation
JOA consists of three sections: daily life (0-14 points), subjective symptoms (0-9 points), and objective symptoms (0-6 points), with a total score of 29 points. The lower the score, the more obvious the functional impairment. The treatment improvement rate and efficacy are calculated based on the JOA score, using the formula: \[(post-treatment score - pre-treatment score) ÷ (29 - pre-treatment score)\] x 100%. Among them, an improvement rate of ≥ 75% is considered excellent; 50% - 74% is considered good; 25% - 49% is considered moderate improvement; 0% - 24% is considered poor. The efficacy judgment standard for the improvement rate is as follows: when the improvement rate is 100%, it is considered cured; when the improvement rate is greater than 60%, it is considered marked improvement; when it is 25% - 60%, it is considered effective; and when it is less than 25%, it is considered ineffective.
次要结局
- Hamilton anxiety scale,HAMA(The 1st day after the operation, 1 month after the operation, 3 months after the operation)
- Visual Analogue Scale，VAS(The 1st day after the operation, 1 month after the operation, 3 months after the operation)
研究者
Suyun Liu
Suyun Liu
Second Affiliated Hospital of Nanchang University