A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Cervical and Thoracic Interlaminar Epidural Injections in Thoracic and Cervical Disc Herniation, Discogenic Pain, and Post-Cervical Laminectomy Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To demonstrate clinically significant improvements or lack thereof with the interlaminar epidural patients with or without steroids
研究概览
简要总结
To study improvements or lack thereof with the interlaminar epidural patients with or without steroids experiences mid back, upper back or neck pain with or without chest wall and upper extremity pain of at least 6-months duration non-responsive to conservative management.
详细描述
This is a Single-center, prospective, controlled, double-blind, randomized study in thoracic and cervical regions.
Patients are studied in 2 groups in each region.
- Group I-local anesthetic only.
- Group II-local anesthetic with 6 mg of non-particulate Celestone.
All patients will be unblinded at 12 or 24 months. Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group, if patient consents. Non-responsive patients may be unblinded and withdrawn from the study at any time.
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
- Double (Participant, Investigator)
盲法说明
Randomly assigned to groups
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
- •Subjects of at least 18 years of age
- •Subjects with a history of chronic, function-limiting thoracic or cervical pain with or without upper extremity pain of at least 6 months in duration
- •Subjects who are able to give voluntary, written informed consent to participate in this investigation
- •Subjects who, in the opinion of the PI, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups
- •Subjects have not had recent surgical procedures within the last 3 months.
排除标准
- •Compressive radiculopathy
- •Narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent
- •Uncontrolled major depression or uncontrolled psychiatric disorders
- •Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease
- •Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function
- •Women who are pregnant or lactating
- •Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
- •Patients with multiple complaints involving concomitant shoulder osteoarthritis, due to the overlap of pain complaints
- •Inability to achieve appropriate positioning and inability to understand informed consent and protocol
- •History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers.
研究组 & 干预措施
Xylocaine
0.5% Xylocaine
干预措施: Xylocaine (Drug)
Xylocaine and Celestone
0.5% Xylocaine with 6 mg of non-particulate Celestone.
干预措施: Xylocaine (Drug)
Xylocaine and Celestone
0.5% Xylocaine with 6 mg of non-particulate Celestone.
干预措施: Xylocaine and Celestone (Drug)
结局指标
主要结局
To demonstrate clinically significant improvements or lack thereof with the interlaminar epidural patients with or without steroids
时间窗: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
examined improvements between those who received and did not receive steroids
次要结局
- To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.(Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.)
- To evaluate and compare the adverse event profile in all patients.(Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.)
研究者
Laxmaiah Manchikanti, MD
Medical Director
Pain Management Center of Paducah