Investigation of the Effectiveness of Electrotherapy Treatment for the Spine in Individuals with Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Pain Catastrophizing Scale
研究概览
简要总结
This study investigates the effectiveness of a specific electrotherapy treatment for individuals with chronic non-specific low back pain. The participants, who had low back pain for more than three months, were divided into two groups: a treatment group and a waitlist control group. The treatment group received electrotherapy using the StimaWELL 120MTRS system, which provided electrical stimulation and heat therapy to the entire spine over four weeks. The study assessed various outcomes, including pain levels, disability, and quality of life, before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •18-65 years old,
- •LBP for more than three months,
- •Pain of 3 or more according to the Numeric Pain Scale
- •being literate
排除标准
- •having a pacemaker,
- •body mass index greater than 30,
- •pathologies of the cervical or lumbar region,
- •cervical radiculopathy, thoracic outlet syndrome, malignant conditions,
- •systemic diseases, such as neurological, psychological, cardiovascular or rheumatologic conditions, loss of function due to these diseases,
- •history of surgery on the spine or upper extremities,
- •acute infection
研究组 & 干预措施
StimaWell
Participants in the StimaWELL group had previously received electrotherapy treatment for the entire spine for 4 weeks, 2 days a week. Before the treatment, participants were informed about their medical condition and the planned treatment. The StimaWELL 120MTRS system (StimaWELL® 120MTRS; Schwa-medico, Wetzlarer Straße 41-43, 35630 Ehringshausen, Germany) was used for the treatment and a stimulation mat was used to apply electrical stimulation along the entire back. The 12 channels of the mat provided different current intensities to different areas and the system offered programs tailored to various therapeutic goals.
干预措施: The StimaWELL 120MTRS system (Device)
Waitlist
Patients presenting to the clinic for treatment and waiting without intervention in the waitlist group after routine evaluation.
结局指标
主要结局
Pain Catastrophizing Scale
时间窗: Before and after 4 weeks of treatment
Participants' pain catastrophizing levels were measured using the Pain Catastrophizing Scale (PCS). The total score of the PCS is 52, with higher scores indicating higher levels of catastrophizing behavior.
次要结局
- Numeric Pain Scale(Before and after 4 weeks of treatment)
- Oswestry Disability Index(Before and after 4 weeks of treatment)
- Nottingham Health Profile(Before and after 4 weeks of treatment)
研究者
Ozlem Ulger
Head of Spine Health Unit, Principal Investigator, Clinical Professor
Hacettepe University