Andrew R. Stephens, Nicholas R. Bender, Jim M. Snyder, Rajeev K. Patel, Ramzi El-Hassan
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Patient Reported Outcome Measurement Information System (PROMIS) domains of Physical Function (PF) v1.2/v2.0 and Pain Interference (PI) v1.1 were collected at all patient visits. Scores were recorded at baseline, 3-months, 6-months and 12-months post-procedure. Statistical analysis comparing baseline scores with follow-up postprocedural PROMIS scores was performed. The percentage of patients reporting improvement greater than the minimal clinically important difference (MCID) was calculated for responders and for the worst case scenario.</div></div><div><h3>Results</h3><div>179 patients met inclusion criteria. PROMIS PI at 3-, 6-, and 12-month follow-up statistically improved by 1.5 (95 % confidence interval [CI] 1.4–1.6; p = 0.02), 1.5 (95 % CI 1.4–1.6; p = 0.03) and 1.7 (95 % CI 1.6–1.8; p = 0.4), respectively. Follow-up PROMIS PF at 3-month follow-up improved by 1.6 (95 % CI 1.5–1.7; p = 0.04) but did not significantly differ at 6- or 12-month follow-up. The percentage of patients that exceeded MCID thresholds of clinical significance was 44 % (95 % CI 36%–53 %) at 3-months, 49 % (95 % CI 39%–59 %) at 6-months, and 54 % (95 % CI 41%–66 %) at 12-months. Worst case scenario analysis demonstrated that 32 % (95 % CI 36%–53 %) of patients exceeded the MCID thresholds at 3-months, 31 % (95 % CI 24%–37 %) at 6-months, and 21 % (95 % CI 15%–27 %) at 12-months.</div></div><div><h3>Discussion/conclusions</h3><div>Our study demonstrated that CIESI leads to an improvement in function and pain for patients with cervical radiculopathy. 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Scores were recorded at baseline, 3-months, 6-months and 12-months post-procedure. Statistical analysis comparing baseline scores with follow-up postprocedural PROMIS scores was performed. The percentage of patients reporting improvement greater than the minimal clinically important difference (MCID) was calculated for responders and for the worst case scenario.</div></div><div><h3>Results</h3><div>179 patients met inclusion criteria. PROMIS PI at 3-, 6-, and 12-month follow-up statistically improved by 1.5 (95 % confidence interval [CI] 1.4–1.6; p = 0.02), 1.5 (95 % CI 1.4–1.6; p = 0.03) and 1.7 (95 % CI 1.6–1.8; p = 0.4), respectively. Follow-up PROMIS PF at 3-month follow-up improved by 1.6 (95 % CI 1.5–1.7; p = 0.04) but did not significantly differ at 6- or 12-month follow-up. The percentage of patients that exceeded MCID thresholds of clinical significance was 44 % (95 % CI 36%–53 %) at 3-months, 49 % (95 % CI 39%–59 %) at 6-months, and 54 % (95 % CI 41%–66 %) at 12-months. Worst case scenario analysis demonstrated that 32 % (95 % CI 36%–53 %) of patients exceeded the MCID thresholds at 3-months, 31 % (95 % CI 24%–37 %) at 6-months, and 21 % (95 % CI 15%–27 %) at 12-months.</div></div><div><h3>Discussion/conclusions</h3><div>Our study demonstrated that CIESI leads to an improvement in function and pain for patients with cervical radiculopathy. 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引用次数: 0
摘要
背景:颈椎椎板间硬膜外类固醇注射(CIESI)常用于治疗由颈神经根撞击引起的颈椎神经根病。目的:评价CIESI对颈椎病患者的治疗效果。方法:我们对在多学科三级学术脊柱中心接受至少6周保守治疗(包括药物治疗和物理康复)失败的连续成年颈椎根状痛和MRI确证的椎间孔狭窄患者进行了回顾性研究。在所有患者就诊时收集患者报告结果测量信息系统(PROMIS)身体功能(PF) v1.2/v2.0和疼痛干扰(PI) v1.1域。在基线、术后3个月、6个月和12个月记录评分。比较基线评分与随访术后PROMIS评分进行统计分析。对于应答者和最坏情况,报告改善大于最小临床重要差异(MCID)的患者百分比进行了计算。结果:179例患者符合纳入标准。3个月、6个月和12个月的PROMIS PI在统计学上提高了1.5(95%可信区间[CI] 1.4-1.6;p = 0.02), 1.5 (95% CI 1.4-1.6;p = 0.03)和1.7 (95% CI 1.6-1.8;P = 0.4)。随访3个月时PROMIS PF改善1.6 (95% CI 1.5-1.7;P = 0.04),但在6个月或12个月的随访中差异无统计学意义。超过MCID临床意义阈值的患者百分比在3个月时为44% (95% CI 36%- 53%), 6个月时为49% (95% CI 39%- 59%), 12个月时为54% (95% CI 41%- 66%)。最坏情况分析表明,32% (95% CI 36%- 53%)的患者在3个月时超过了MCID阈值,31% (95% CI 24%- 37%)的患者在6个月时超过了阈值,21% (95% CI 15%- 27%)的患者在12个月时超过了阈值。讨论/结论:我们的研究表明CIESI可以改善颈神经根病患者的功能和疼痛。这项研究受到回顾性设计、随访缺失和使用类固醇的差异的限制。
Evaluating the effectiveness of interlaminar epidural steroid injections for cervical radiculopathy using PROMIS as an outcome measure
Background
Cervical interlaminar epidural steroid injections (CIESI) are frequently used to treat cervical radiculopathy due to cervical nerve root impingement.
Objective
The purpose of this study was to evaluate the therapeutic effect of CIESI for patients with cervical radiculopathy.
Methods
We conducted a retrospective review of consecutive adult patients with cervical radicular pain and corroborative cervical spondylotic foraminal stenosis on MRI that failed at least 6 weeks of conservative management consisting of medication and physical rehabilitation seen at a multidisciplinary, tertiary academic spine center. Patient Reported Outcome Measurement Information System (PROMIS) domains of Physical Function (PF) v1.2/v2.0 and Pain Interference (PI) v1.1 were collected at all patient visits. Scores were recorded at baseline, 3-months, 6-months and 12-months post-procedure. Statistical analysis comparing baseline scores with follow-up postprocedural PROMIS scores was performed. The percentage of patients reporting improvement greater than the minimal clinically important difference (MCID) was calculated for responders and for the worst case scenario.
Results
179 patients met inclusion criteria. PROMIS PI at 3-, 6-, and 12-month follow-up statistically improved by 1.5 (95 % confidence interval [CI] 1.4–1.6; p = 0.02), 1.5 (95 % CI 1.4–1.6; p = 0.03) and 1.7 (95 % CI 1.6–1.8; p = 0.4), respectively. Follow-up PROMIS PF at 3-month follow-up improved by 1.6 (95 % CI 1.5–1.7; p = 0.04) but did not significantly differ at 6- or 12-month follow-up. The percentage of patients that exceeded MCID thresholds of clinical significance was 44 % (95 % CI 36%–53 %) at 3-months, 49 % (95 % CI 39%–59 %) at 6-months, and 54 % (95 % CI 41%–66 %) at 12-months. Worst case scenario analysis demonstrated that 32 % (95 % CI 36%–53 %) of patients exceeded the MCID thresholds at 3-months, 31 % (95 % CI 24%–37 %) at 6-months, and 21 % (95 % CI 15%–27 %) at 12-months.
Discussion/conclusions
Our study demonstrated that CIESI leads to an improvement in function and pain for patients with cervical radiculopathy. This study was limited by retrospective design, loss to follow-up, and variation in steroids used.