Acupuncture Treatment for Pain Relief and Functional Recovery in Patients With Vertebral Compression Fracture
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Pain intensity on the Visual Analog Scale (VAS)
研究概览
简要总结
Patients with vertebral compression fractures (VCF) may experience pain, limitation of daily activities, and various complications (e.g., insomnia, constipation, urinary infection, depression, diminished quality of life).
Objective:
This study aims to evaluate the effectiveness, safety and feasibility of acupuncture treatments to achieve pain relief and functional recovery in patients with VCF.
详细描述
Patients who have subacute or chronic vertebral compression fracture in one or more thoracic/lumbar vertebral body are eligible. Patients who have willingness to participate and provide written informed consents will be treated to the Pusan National University Korean Medicine Hospital with once to three times per weak for six weeks approximately. (total 12-18 sessions)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 19 years of age
- •Radiographic confirmation of one more subacute or chronic stable vertebral compression fractures (x-ray, computerized tomography, or magnetic resonance imaging)
- •Patient-reported pain intensity equal or greater than 4 points on 0 to 10 VAS scale at baseline
- •Willingness to participate in the study and provide written informed consent
- •Is able to give written consent independently or with a supporter's help
排除标准
- •Pathological fracture (malignancy, myeloma, metabolic disease, etc.)
- •Spine malformation
- •Pregnancy, infection, impaired cognitive function
- •Hypersensitive reaction to acupuncture treatment
- •Need for surgical treatment
- •Neurologic deficit: spinal cord injury, cauda equina syndrome
- •Unstable fracture: three-column collapse, burst fracture, posterior ligament rupture, distraction fracture
- •Scoliotic angle ≥ 12°
研究组 & 干预措施
Integrative Treatments
This study's arm is single, so all participants will receive acupuncture treatments.
干预措施: acupuncture (Procedure)
结局指标
主要结局
Pain intensity on the Visual Analog Scale (VAS)
时间窗: 6 weeks from the first treatment
VAS will be used to assess pain intensity reflecting average patient-perceived pain during the previous 24 hours. The scale ranges from 0 (no pain) to 10 (the worst pain imaginable).
次要结局
- Patient's satisfaction with treatment using the Patient Global Assessment(PGA)(6 weeks from the first treatment)
- Back-specific dysfunction using the Oswestry Disability Index (ODI)(baseline, 6 weeks from the first treatment, 12 weeks from the first treatment)
- Quality of life using the Quality-of-Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)(baseline, 6 weeks from the first treatment, 12 weeks from the first treatment)
- Physical function using Time Up and Go (TUG)(baseline, 6 weeks from the first treatment)
- Adverse events related to integrative treatments as a measure of safety(under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment)
- Use of medication for pain control during treatment(under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment)
- Number of patients who received surgery(12 weeks from the first treatment)