A Randomized, Double-Blind, Placebo Controlled Perspective Study of Intraarticular Lumbar Zygapophysial Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Numeric Pain Rating (NPR) or patient estimation of improvement, >80% pain reduction
研究概览
简要总结
Subjects (N=120) who have had non-radicular low back pain, believed by clinical assessment and imaging to be consistent with lumbar zygapophysial joint (Z-joint) generated pain, who have failed conservative therapy including physical therapy, have had an initial >80% pain relief on a diagnostic medial branch block, and are scheduled to undergo a routine second medial branch block for facet mediated pain will be randomized. Both groups will receive the standard of care, a medial branch block. The treatment group will also receive one set of intra-articular lumbar Z-joint corticosteroid injection and the placebo group will receive intra-articular normal saline.
详细描述
Subjects will have failed conservative treatment, including, but not limited to oral medications, physical therapy, chiropractic treatment, and/or alternative medicine. They will be evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics and will be schedule for a medial branch block as standard of care. As part of usual and standard care, patients will undergo lumbar medial branch blocks for diagnosis of zygapophysial joint pain.
Patients who obtain ≥ to 80% relief of their index pain with a first set of lumbar medial branch blocks will be offered the opportunity for possible inclusion in the study if they are scheduled to receive a second medial branch block. The definition of a positive response to MBB's is an 80% reduction in pain (by change in NPR scores or estimated patient improvement) AND the restoration of the ability to perform at least one previously painful posture, movement, or activity without increase in pain, during the anesthetic phase of the blocks. If subjects are unable to render NPR scores or percentage estimate of improvement, then a 5 point global perception of effect tool will be used.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low back pain episode greater than six months in duration
- •NPR pain scale score three day average and present pain of at least four/ten at baseline (index pain)
- •Previous medial branch block providing >80% pain relief for current painful episode
- •Subject must be scheduled to undergo a second medial branch block for their back pain
排除标准
- •Litigation
- •Those seeking new or increased long-term remuneration
- •Leg pain greater than back pain
- •Radicular pain or evidence of neurological compromise in the lower limbs
- •Those unable to read English and complete the assessment instruments
- •Systemic inflammatory arthritis (e.g. rheumatoid, lupus)
- •Addictive behavior, severe clinical depression or psychotic features. The subjects will be identified at the sole discretion of the PI who per the current standard of care will consent the potential subjects to the study
- •Significant lower extremity pathology that affects gait
- •Sustained cervical or thoracic pain that is present at a level >3/10 on NPR
- •Possible pregnancy or other reason that precludes the use of fluoroscopy
- •Significant scoliosis
- •Radicular/neurological deficits or focal disc herniation and/or stenosis, with correlating radicular symptoms
- •Contra-indication to corticosteroid, including known allergies or sensitivities
- •History of prior epidural spinal injections relieving their current pain, or prior lumbar surgery.
研究组 & 干预措施
Intra-articular corticosteroid injection
Intra-articular corticosteroid injection in conjunction with confirmatory anesthetic medial branch blocks
干预措施: Intra-articular corticosteroid injection (Drug)
Intra-articular saline injection
Intra-articular saline injections with confirmatory anesthetic medial branch blocks
干预措施: Intra-articular saline injection (Drug)
结局指标
主要结局
Numeric Pain Rating (NPR) or patient estimation of improvement, >80% pain reduction
时间窗: Hourly for 6 hours post injections
A positive response is defined as are ≥ 80% reduction in pain (by change in NPR scores or estimated patient improvement) AND the restoration of the ability to perform at least one previously painful posture, movement, or activity without increase in pain, during the anesthetic phase of the blocks.
次要结局
- Oswestry Disability Index (ODI)(6 weeks, 3 months, 6 months, 12 months)
- Daily Work History Log(reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up)
- Numeric Pain Rating (NPR) Daily diary(reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up)
- Daily Analgesic Use Log(reviewed at 6 weeks, 3 months, 6 months, 12 months)
- Standard Form 36 (SF-36), General Health Survey(6 weeks, 3 months, 6 months, 12 months)
- Ancillary Treatment Log(reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up)