GOLDIC Therapy in Lumbar Degenerative Spinal Stenosis - Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in EQ-5D-5L index from baseline to 24 weeks
研究概览
简要总结
The trial aims to compare the effectiveness of three methods of conservative treatment of degenerative lumbar spine stenosis (DLSS): GOLDIC autologous serum epidural injections, steroid epidural injections and manual therapy.
详细描述
BACKGROUND: Degenerative Lumbar Spinal Stenosis (DLSS) is a serious health problem for patients over 65 years of age. It is assumed that in the United States alone, it affects about 200 thousand patients causing significant impairment of their quality of life. Although it is relatively easy to confirm the nature of spinal canal encroaching (disc protrusion, facet hypertrophy, ligamentous folding) by several methods of imaging, the golden standard of DLSS management, especially in the group of older patients, is still the matter of debate. Three main concepts of conservative treatment are considered: 1) pharmacological care - symptom-oriented systemic anty-inflammatory and analgesic agents or local steroid injections, 2) rehabilitations protocols and mechanical devices like traction facilities or corsets to decompress spinal canal or support in case of instability, 3) biological - stimulation of anti-inflammatory action and regeneration capacity by biologically active substances. All methods are offered without strong evidence of its efficacy.
AIM: Comparison of the effectiveness of three treatment protocols in DLSS: epidural injections of autologous serum (Gold Induced Cytokines, Goldic), epidural steroid injections, manual therapy in the concept of spinal canal venous drainage.
Research hypothesis: The use of Goldic serum in epidural injections improves the condition of patients with DLSS during the observation period longer than steroid injections and the rehabilitation protocol.
DESIGN: Randomized prospective trial without blinding. SETTING: Open study for outpatients, single-centre study. POPULATION: the local adult population METHODS: Three groups of patients (A, B, C) with confirmed DLSS in MRI, without limiting sex, age, meeting health conditions according to the inclusion and exclusion criteria. There will be 30 people in each group (90 people in total).
Group A - Goldic serum therapy - 4 injections at 3-day intervals containing single doses of serum (4 doses of 3 ml in total), injections performed into the epidural space under ultrasound control by the same operator.
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
- None
盲法说明
None (Open label)
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
- •Clinical signs of lumbar spinal stenosis
- •Radiological signs of lumbar spinal stenosis confirmed by MRI
- •No contraindications to steroid therapy or spinal epidural injections (glaucoma, high RR values, diabetes, anticoagulants, active infections, etc.)
- •Mental state allowing cooperation during manual therapy
- •An adult who consents to participate in the study
- •No previous surgery or spinal epidural injections
排除标准
- •The presence of serious neurological deficits
- •Stenosis of other origin - post-traumatic, spondylolisthesis, cancer, infection
- •Contraindications to steroid therapy or spinal injections (glaucoma, high RR values, diabetes, anticoagulants, active infections, etc.)
- •Previous surgery or spinal epidural injections of lumbar spine
- •Mental state preventing cooperation during manual therapy
- •Lack of consent to participate in the study
研究组 & 干预措施
GOLDIC serum
Epidural ultrasound guided injections
干预措施: Goldic serum (Combination Product)
Steroid
Epidural ultrasound guided injections
干预措施: Steroid injections (Drug)
Manual therapy
veno-lymphatic spinal drainage
干预措施: Manual therapy (Procedure)
结局指标
主要结局
Change in EQ-5D-5L index from baseline to 24 weeks
时间窗: Change from baseline to 24 weeks
EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
Change in Oswestry Disability Index from baseline to 24 weeks
时间窗: Change from baseline to 24 weeks
Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).
Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 24 weeks
时间窗: Change from baseline to 24 weeks
Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score).
次要结局
- Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 4 weeks(Change from baseline to 4 weeks)
- Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 12 weeks(Change from baseline to 12 weeks)
- Change in pain intensity according to Numeric Rating Scale(Change from baseline to 24 weeks)
- Change in EQ-5D-5L index from baseline to 4 weeks(Change from baseline to 4 weeks)
- Change in EQ-5D-5L index from baseline to 12 weeks(Change from baseline to 12 weeks)
- Change in Oswestry Disability Index from baseline to 4 weeks(Change from baseline to 4 weeks)
- Change in Oswestry Disability Index from baseline to 12 weeks(Change from baseline to 12 weeks)
研究者
Piotr Godek
Principal Investigator
Sutherland Medical Center