Efficacy of Internet-Based Cognitive Behavioral Therapy for Back Muscle Strength Loss, Chronic Pain, and Poor Patient Recovery Perceptions After Lumbar Fusion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- TSK Scores
研究概览
简要总结
This study aims to develop an Internet-based Cognitive Behavioral Therapy protocol for core muscle training, based on an understanding of factors impeding postoperative core muscle training in lumbar surgery patients. The protocol is designed to reconstruct patients' cognition, eliminate adverse behaviors, and promote healthy behaviors such as core muscle training among LDH patients. The ultimate objectives are to alleviate postoperative pain, enhance lumbar stability, and facilitate disease rehabilitation in patients following lumbar surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 55 years
- •diagnosis of lumbar disc herniation requiring single-level lumbar fusion surgery - no previous history of lumbar surgery
- •Surgical procedures performed by the same surgical team
- •willingness to comply with the study protocol and restrictions
- •availability of a home WiFi connection
排除标准
- •lumbar surgery secondary to neoplasm, tuberculosis, infection, or inflammation
- •postoperative infection or revision surgery
- •presence of cauda equina syndrome
- •diagnosis of schizophrenia, cognitive impairment, or other psychiatric disorders
- •coexisting severe cardiovascular or cerebrovascular diseases, or congenital conditions precluding exercise participation.
研究组 & 干预措施
The intervention group
The research team developed a comprehensive core muscle training protocol based on internet-delivered cognitive behavioral therapy through the digital rehabilitation platform.
干预措施: Internet-delivered cognitive behavioral therapy (Behavioral)
The intervention group
The research team developed a comprehensive core muscle training protocol based on internet-delivered cognitive behavioral therapy through the digital rehabilitation platform.
干预措施: Basic Postoperative Care (Behavioral)
The control group
The control group received conventional postoperative care interventions
干预措施: Basic Postoperative Care (Behavioral)
The control group
The control group received conventional postoperative care interventions
干预措施: Conventional Postoperative Care (Behavioral)
结局指标
主要结局
TSK Scores
时间窗: The TSK scores were collected at baseline and at 1 week, 1 month, 3 months, and 6 months post-intervention.
The Tampa Scale of Kinesiophobia (TSK) was administered to evaluate kinesiophobia in both groups before and after intervention. The TSK is a validated 17-item questionnaire, with each item scored on a 4-point scale. The TSK consists of 17 items with a total score ranging from 17 to 68 points, with higher scores indicating greater severity of kinesiophobia.
Exercise Adherence
时间窗: Exercise adherence scores were collected at baseline and at follow-up intervals of 1 week, 1 month, 3 months, and 6 months post-intervention.
The Orthopedic Patient Exercise Compliance Scale total score (ranging from 15 to 75 points) will be used to evaluate patients' adherence to postoperative functional exercises, using a 15-item questionnaire that assesses three dimensions (physical, psychological, and active learning aspects). Each item is scored on a 5-point Likert scale (1 = completely unable to 5 = completely able), with higher total scores indicating better exercise compliance (\>55 points represents high adherence, 20-55 points indicates partial adherence, and \<20 points indicates low adherence).
Pain Intensit
时间窗: Pain scores were collected at baseline and follow-up intervals of 1 week (at discharge), 1 month, 3 months, and 6 months post-intervention.
Pain severity will be measured using the Numerical Rating Scale (NRS) total score (ranging from 0 to 10 points), a validated 11-point scale for pain assessment. Pain levels are categorized according to the following scoring criteria: 0 = no pain, 1-3 points = mild pain, 4-6 points = moderate pain, 7-9 points = severe pain, and 10 points = extreme pain, with higher scores indicating greater pain severity.
次要结局
- Lumbar Function(The JOA scores were collected at baseline, 3 months, and 6 months post-intervention.)
- Trunk Shift (Spinal Alignment)(Measurements were obtained at baseline, 3 months, and 6 months post-intervention.)
- Pelvic Torsion(Measurements will be obtained at baseline, 3 months, and 6 months post-intervention.)
- Maximum Vertebral Rotation(Measurements will be obtained at baseline, 3 months, and 6 months post-intervention.)
研究者
Jiawei Jiang
Attending Physician
Affiliated 2 Hospital of Nantong University