Department of Orthopedic Surgery, Vanderbilt University Medical Center, Nashville, TN.
Vanderbilt Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN.
Spine (Phila Pa 1976). 2020 Feb 15;45(4):217-225. doi: 10.1097/BRS.0000000000003239.
Pilot randomized controlled trial.
To examine the acceptability and preliminary safety and outcome effects of an early self-directed home exercise program (HEP) performed within the first 6 weeks after anterior cervical discectomy and fusion (ACDF).
Little is known regarding optimal postoperative management after ACDF.
Thirty patients (mean ± standard deviation, age = 50.6 ± 11.0 years, 16 women) undergoing ACDF were randomized to receive an early HEP (n = 15) or usual care (n = 15). The early HEP was a 6-week self-directed program with weekly supportive telephone calls to reduce pain and improve activity. Treatment acceptability was assessed after the intervention period (6 weeks after surgery). Safety (adverse events, radiographic fusion, revision surgery) was determined at routine postoperative visits. Disability (Neck Disability Index), pain intensity (Numeric Rating Scale for neck and arm pain), physical and mental health (SF-12), and opioid use were assessed preoperatively, and at 6 weeks and 6 and 12 months after surgery by an evaluator blinded to group assignment.
Participants reported high levels of acceptability and no serious adverse events with the early HEP. No difference in fusion rate was observed between groups (P > 0.05) and no participants underwent revision surgery. The early self-directed HEP group reported lower 6-week neck pain than the usual care group (F = 3.3, P = 0.04, r = 0.3, mean difference = -1.7 [-3.4; -0.05]) and lower proportion of individuals (13% vs. 47%) using opioids at 12 months (P = 0.05). No other between-group outcome differences were observed (P > 0.05).
An early self-directed HEP program was acceptable to patients and has the potential to be safely administered to patients immediately after ACDF. Benefits were noted for short-term neck pain and long-term opioid utilization. However, larger trials are needed to confirm safety with standardized and long-term radiograph assessment and treatment efficacy.
先导随机对照试验。
研究颈椎前路椎间盘切除融合术（ACDF）后 6 周内进行早期自我指导家庭运动方案（HEP）的可接受性以及初步的安全性和结果效果。
颈椎前路融合术后的最佳术后管理方法知之甚少。
30 例患者（平均年龄±标准差，50.6±11.0 岁，16 名女性）行 ACDF 术，随机分为接受早期 HEP（n=15）或常规治疗（n=15）。早期 HEP 为 6 周的自我指导方案，每周进行一次支持性电话随访，以减轻疼痛和改善活动度。在干预期（术后 6 周）后评估治疗的可接受性。在常规术后就诊时确定安全性（不良事件、影像学融合、翻修手术）。术前及术后 6 周、6 个月和 12 个月采用盲法评估患者的残疾（颈椎残障指数）、疼痛强度（颈痛和臂痛数字评分量表）、身心健康（SF-12）和阿片类药物使用情况。
参与者报告对早期 HEP 有较高的接受度，没有出现严重不良事件。两组间融合率无差异（P＞0.05），也没有患者接受翻修手术。早期自我指导 HEP 组术后 6 周的颈痛评分低于常规治疗组（F=3.3，P=0.04，r=0.3，平均差值=-1.7[-3.4；-0.05]），12 个月时使用阿片类药物的患者比例也更低（13%比 47%）（P=0.05）。未观察到其他组间结局差异（P＞0.05）。
早期自我指导 HEP 方案患者接受度高，有可能在 ACDF 后立即安全地用于患者。短期颈痛和长期阿片类药物使用的获益明显。然而，需要更大规模的试验来确认安全性，并采用标准化和长期影像学评估以及治疗效果。
2 级。
