Impact of Muscle Degeneration in Chronic Ow Back Pain in Patients Undergoing Neural Decompression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity
研究概览
简要总结
Surgical interventions for the removal of intervertebral disc fragments or to enlarge a narrow spine canal are commonly performed worldwide and are considered efficient. Concomitant low back pain is not uncommon among patients with lumbar nerve compression and neurological symptoms. When present, controversy persists in the literature regarding its ideal management. Although neurological symptoms improve after decompressive surgery, the presence of residual chronic low back pain may worsen satisfaction scores and cause functional disability.
The hypothesis of the present study is that the presence of atrophy of the paraspinal and trunk muscles predicts chronic low back pain after lumbar neural decompression. If confirmed, this finding will aid in better planning of physical rehabilitation strategies for this group of patients, as well as a clearer prediction regarding surgical treatment outcomes for patients and health professionals.
详细描述
This is a prospective cohort study. Patients with lumbar degenerative diseases and symptoms of nerve compression (radiculopathy or neurogenic claudication) who will undergo surgical treatment for neural decompression (discectomy, foraminotomy or laminectomy).
The cohort will be followed by a team researcher (not blinded to the purpose of the study) at preoperative (up to 1 month before surgery), immediate postoperative (12 to 24 hours after procedure), 06, 12 and 24 months after surgery. Imaging tests will be performed on the preoperative evaluation and at six months follow-up after the operation.
The treatment will consist of lumbar decompression surgery, which may consist of discectomy, foraminotomy or laminectomy, according to the type and location of the compression. The choice of surgical technique will be made by the assistant surgeon.
Patients will be divided into four groups regarding the type of soft tissue retractor and image magnification:
Group 1: (minimally invasive microdiscectomy): surgeries performed with loupes or microscope plus minimally invasive soft tissue retractors (tubular or "Caspar").
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults 18 years of age and older;
- •with symptoms of lumbosacral neural compression (radiculopathy or neurogenic lameness);
- •failed conservative treatment for at least 6 weeks;
- •undergoing surgery for neural decompression (discectomy and / or foraminotomy and / or hemilaminectomy);
- •with complete pre and postoperative medical records in all evaluations.
排除标准
- •need for lumbar arthrodesis;
- •deep infection requiring surgical cleaning;
- •patients submitted to joint facet rhizotomy;
- •active rheumatologic disease, including seronegative arthropathies.
结局指标
主要结局
Change in Pain Intensity
时间窗: Baseline, 3, 6, 12 and 24 months after surgery
Pain intensity will be measured using VAS 0-10 (0 being no pain and 10 maximum pain)
次要结局
- Change in Kinesiophobia(Baseline, 3, 6, 12 and 24 months after surgery)
- Change in Disability(Baseline, 3, 6, 12 and 24 months after surgery)
- Radiological evaluation(Baseline and 6 month after surgery)
- Change in Quality life(Baseline, 3, 6, 12 and 24 months after surgery)
- Change in Psychosocial Risk Prognosis(Baseline, 3, 6, 12 and 24 months after surgery)
- Change in Global Impression of Recovery(Baseline, 3, 6, 12 and 24 months after surgery)
- Change in Mood Disorders in The setting of Medical Practice(Baseline, 3, 6, 12 and 24 months after surgery)