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临床试验/NCT07550660
NCT07550660已完成不适用

Effects of Different Rehabilitation Interventions on Neuropathic Pain, Functional Recovery, and Quality of Life in Postoperative Patients With Degenerative Lumbar Disease: A Randomized Controlled Trial

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Change From Baseline in Taiwan Version of Neuropathic Pain Symptom Inventory (NPSI-T) Score

研究概览

简要总结

The purpose of this study is to evaluate the effects of different rehabilitation interventions on patients who have undergone surgery for degenerative lumbar disease. The study focuses on assessing improvements in neuropathic pain, functional recovery, and overall quality of life. Participants will be randomly assigned to different rehabilitation programs to determine which approach provides the best outcomes for postoperative recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Participants were informed that they would be assigned to one of different postoperative rehabilitation programs but were not told the specific differences between the exercise protocols.

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed by a neurosurgeon with lumbar spinal stenosis, spondylolisthesis, or spondylosis involving L2-S1 segments, and scheduled for lumbar spine surgery.
  • First-time recipients of lumbar spine surgery.
  • Adults who are conscious and able to communicate effectively in Mandarin/Taiwanese (verbally or through writing).
  • No history of psychiatric disorders.
  • Willing to participate and sign the informed consent form.

排除标准

  • Lower back pain caused by infection, inflammation, or malignancy (cancer).
  • History of previous lumbar spine surgery.
  • Patients with substance or drug addiction.
  • Presence of psychiatric disorders.
  • Unable to communicate effectively.

研究组 & 干预措施

Experimental Group A: Stretching and Core Training

Experimental

Participants receive a combination of stretching exercises and core stability training.

干预措施: Stretching and Core Stability Exercise Program (Group A) (Behavioral)

Experimental Group A: Stretching and Core Training

Experimental

Participants receive a combination of stretching exercises and core stability training.

干预措施: Core Stability Exercise Program (Group B) (Behavioral)

Experimental Group B: Core Training

Experimental

Participants receive core stability training only.

干预措施: Core Stability Exercise Program (Group B) (Behavioral)

Control Group

Active Comparator

Participants receive standard postoperative nursing care and education without specific exercise intervention.

干预措施: Standard Postoperative Nursing Care (Other)

结局指标

主要结局

Change From Baseline in Taiwan Version of Neuropathic Pain Symptom Inventory (NPSI-T) Score

时间窗: Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.

The NPSI-T evaluates 4 dimensions of neuropathic pain: spontaneous pain, paroxysmal pain, evoked pain, and dysesthesia. It consists of 18 items (including added items for cold pain, itching, and numbness). Each item is scored from 0 to 10. The total score ranges from 0 to 180, where a higher score indicates more severe neuropathic pain.

次要结局

  • Change From Baseline in Oswestry Disability Index (ODI) Version 2.1 Score(Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.)
  • Change From Baseline in 12-item Short Form Health Survey (SF-12) Score(Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.)
  • Change From Baseline in 50-foot Walk Test Time(Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.)
  • Change From Baseline in Repeated Sit-to-Stand Test Time(Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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