ISRCTN12741173招募中不适用
A prospective clinical trial to evaluate the influence of surface EMG-triggered multichannel electrical stimulation on sensomotoric recovery in patients with lumbar disc herniation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Population 1 – Patients being operatively treated
- •1. Patients with a lumbar disc herniation causing sensomotoric dysfunction in nerve root distribution areas L3 to S1
- •2. Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or significant motor deficit or signs of nerve root compression in the face of conservative treatment
- •3. An indication for surgical treatment according to the guidelines of DGNC and DGOOC
- •4. MRI determined pathology at treatment level that correlates to primary symptoms
- •Population 2 – Patients being conservatively treated
- •1. Patients with a lumbar disc herniation causing sensomotoric dysfunction in nerve root distribution area L3 to S1
- •2. No urgent indication for surgical treatment according to the guidelines of DGNC and DGOOC
- •3. MRI determined pathology at treatment level that correlates to primary symptoms
- •Population 1 and 2
- •1. Age between 18 and 65 years
- •2. Skeletally mature
- •3. Willing and able to understand the study and to provide informed consent to participate
- •4. Physically and mentally able to participate in the study, including study treatment and post-study treatment pain
- •5. Able to understand and to complete study-relevant questionnaires in German language
排除标准
- •1. Cardiac pacemaker
- •2. Pregnancy
- •3. Any degenerative muscular or neurological condition that would interfere with
- •4. Evaluation of outcome measures including but not limited to Parkinson's disease, amytrophic lateral sclerosis, multiple sclerosis, muscular dystrophy and myelopathic diseases of different causes myelopathy
- •5. Unable or unwilling to comply therapeutic instructions or to comply the follow-up visits at the study site
- •6. Active or chronic infection, systemic or local, systemic disease including HIV, AIDS, Hepatitis, Syphilis
- •7. Unable to undergo MRI
- •8. Active malignancy defined as a history of any invasive malignancy, except nonmelanoma skin cancer, unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for a minimum of 5 years
- •neoplasia as the source of symptoms
- •9. Diabetes mellitus
- •10. Paget’s disease, osteomalacia, osteoporosis or other metabolic bone disease
- •11. Skin disease that influences sensory nerve function
- •12. Polyneuropathy
- •13. Autoimmune disorder that impacts the musculoskeletal system (i.e. lupus, rheumatoid arthritis, ankylosing spondylitis)
- •14. Acute episode or major mental illness (psychosis, major affective disorder or schizophrenia) and usage of anti-depressive drugs
- •15. Physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin
- •16. Recent or current history of substance abuse ( alcohol, narcotics, recreational drugs)
- •17. Pursuing personal litigation related to spinal diseases
- •18. Prisoner or ward of the state
- •Radiological Exclusion Criteria
- •1. Previous or acute spondylodiscitis
- •2. Previous compression or burst fracture at the level(s) to be treated
- •3. Central canal stenosis causing radiculopathy or clinical myelopathy (by MRI)
- •4. A spinal tumor
研究者
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