DRKS00032192招募中Unknown
Multicentric, prospective, controlled, randomized study on the effectiveness of lumbar supports in the treatment of acute or sub-acute, non-specific back pain - LumboTrain
niversität Osnabrück0 个研究点目标入组 146 人开始时间: 2023年7月3日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 146
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 25 Years 至 65 Years(—)
- 性别
- All
入选标准
- •Presence of acute or sub-acute, non-specific low back pain, new (acute) or for < 3 months, but not more than 2 times in the last year; sufficient psychological stability, assessed by the doctor; sufficient mental and linguistic abilities to fill in the questionnaires and to take part in the examinations, assessed by the doctor; assumed reliability with regard to the ability to meet the requirements of the study (i.e., to comply with the wearing time with the bandage and/or to be able to handle the bandage correctly), assessed by the doctor; presence of a signed declaration of consent
排除标准
- •Chronic back pain (pain at the time of medical consultations longer than 3 months); Osteoporosis, if treated with osteoporosis-specific drugs (e.g. bisphosphonates, parathormones); osteoporosis is not considered an exclusion criterion if the treatment is simply supplemented with vitamin D and calcium; Presence of a depression requiring therapy that is being treated with antidepressants; Previous operations on the spine / in the back area; Specific back/spine diseases, such as: Activated facet joint arthrosis (= spondylarthrosis), inflammatory diseases with back involvement, acute radicular symptoms with radiating pain (radicular character) or segmental, sensory or motor paresis, fractures, tumor diseases; Disorders/disorders of the lower extremities that severely impair gait and standing with trunk alterations; paralysis of the lower extremities; High mental stress and psychosocial abnormalities, assessed by the doctor; Psychosocial stress, assessed by the doctor: exclusion with a score of = 9 points (= upper third of the scale; 'strong or very strong psychosocial stress') when using the psychosocial screening questionnaire: UKS dr D. Kuch; Interventional therapies carried out (e.g. injections near the spine; endoscopic or surgical interventions on the spine) in the last year; Abdominal circumference of more than 145 cm (obesity per magna), as there is no sufficiently large lumbar bandage for these people
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