The Effect of Close Follow-up by a Physician in Addition to a Conventional Physical Therapy Program in Patients With Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Visual Analog Scale
研究概览
简要总结
This study will include patients aged 18-65 with subacute or chronic mechanical low back pain who apply to the Physical Medicine and Rehabilitation Clinic. The age, gender, body mass index, duration of low back pain, smoking status, and educational status of the patients included in the study will be recorded. Patients will be randomized into two groups: the study group and the control group. First, the psychosocial risk status of patients in both groups will be determined using the STarT Back Screening Tool. Then, patients in the control group will undergo a conventional physical therapy program that includes hot packs, transcutaneous electrical nerve stimulation, ultrasound, and core stabilization exercises. Patients in the study group will undergo daily close follow-up physician-patient meetings during the sessions, in addition to the conventional physical therapy program applied to the control group. Clinical assessments will be performed using the Visual Analogue Scale (VAS), Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, Beck's Depression Scale, Roland-Morris Disability Questionnaire, and Leeds Assessment of Neuropathic Symptoms and Signs. Clinical evaluations will be conducted at baseline, on Day 5 post-treatment, and at 1 month post-treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 with subacute or chronic mechanical back pain and considered appropriate for a physical therapy program.
排除标准
- •Patients describing inflammatory back pain
- •Spondyloarthropathies and other rheumatological diseases
- •History of spinal surgery
- •Patients with sensory disturbances and psychiatric diagnoses
- •Fibromyalgia
- •Patients with malignancies
- •Patients with active infectious findings
- •Patients with a history of radiotherapy
结局指标
主要结局
Visual Analog Scale
时间窗: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.
Visual Analog Scale (VAS) score ranges from 0 to 10. High scores describe more pain, and low scores describe less pain.
次要结局
- Tampa Scale of Kinesiophobia(It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.)
- The Pain Catastrophizing Scale(It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.)
- Beck Depression Inventory(It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.)
- Roland-Morris Disability Questionnaire(It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.)
- Leeds Assessment of Neuropathic Symptoms and Signs(It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.)
研究者
Hüdanur Coşkun
Principal Investigator
Istanbul Training and Research Hospital