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经皮喙肱韧带松解术治疗粘连性肩关节囊炎:一项随机对照交叉研究的两年结果。

Percutaneous Coracohumeral Release for Patients with Adhesive Capsulitis: Two-Year Results from a Randomized Control Crossover Study.

机构信息

Department of Physical Medicine and Rehabilitation, Montefiore Medical Center, NY.

Louisiana State University School of Medicine, Shreveport, LA.

出版信息

Pain Physician. 2024 Jul;27(5):303-307.

Abstract

BACKGROUND

Adhesive capsulitis (AC) causes a variety of symptoms, including but not limited to pain, stiffness, and a gradual restriction of active and passive range of motion (ROM). The coracohumeral ligament (CHL) plays an important role in this disease process, and percutaneous CHL release (PCHLR) has demonstrated efficacy in treating manifestations of this disorder that are refractory to pain medication, physical therapy, and local injections. Our previous study demonstrated one-year efficacy and durability, and this study examines 2-year data from our original randomized control crossover cohort.

OBJECTIVE

To highlight the importance of extended follow-ups evaluating PCHLR's efficacy in AC management.

STUDY DESIGN

A prospective, randomized, controlled, cross-over trial.

SETTING

An academic medical center.

METHODS

Patients with AC refractory to oral medication, physiotherapy, and at least one local injection were included in our original study. In all, there were initially 40 patients (46 shoulders), including 6 patients who underwent bilateral PCHLR using the Tenex® system. In this prospective study, 2 groups, the experiment group (scheduled to receive PCHLR) and the control group (scheduled to receive a local anesthetic in the coracohumeral ligament [LACHL]) were determined through 2-to-1 block randomization. Of these 46 shoulders initially treated, 39 remained in the study at one year. Twenty-six of the 39 shoulders were assigned to the PCHLR group whereas 13 were assigned to the LACHL group. Nine out of 13 shoulders in the LACHL group crossed over to the PCHLR group. Ultimately, 31 shoulders remained in the PCHLR group for 2-year analysis. The effectiveness of these interventions was assessed using a variety of parameters. Pain scores, ROM, and the Oxford Shoulder Score (OSS) were evaluated before the procedure and at one-year and 2-year follow-up visits.

RESULTS

In this 2-year follow-up study, a total of 31 shoulders were sampled, comprising 22 women and 5 men, with 4 patients undergoing bilateral procedures. The mean age of the patients was 65 years (± 11.48). Patients' mean body mass index (BMI) was 36.33 (± 6.55), and the mean CHL thickness was 38.5 (± 3.45). Osteoarthritis was present in 11 cases. The mean follow-up period for the study was 29.7 months (± 6.39). The baseline mean external rotation was 30° (± 8), which increased to 62° (± 18) at one year and 53° (± 18) at 2 years. The baseline mean abduction was 60° (± 16), which improved to 77° (± 21) at one year and 68° (± 20) at 2 years. The median NRS decreased from 8 (IQR: 8, 9) at baseline to 3 (IQR: 2, 7) at one year and 5 (IQR: 2, 7) at 2 years. The baseline median OSS was 7 (IQR: 3, 10), which increased to 32 at one year and 22 (IQR: 15, 35) at 2 years.

LIMITATIONS

The present investigation has a limited sample size of patients who have ROM impairment caused by CHL thickening.

CONCLUSIONS

While the algorithm for AC care has seen little change for several decades, the authors suggest that PCHLR is a safe, durable, and effective option for cases of AC that are refractory to traditional management.

摘要

背景

粘连性肩关节囊炎(AC)会引起多种症状,包括但不限于疼痛、僵硬和主动及被动活动范围(ROM)逐渐受限。喙肱韧带(CHL)在这个疾病过程中起着重要作用,经皮 CHL 松解术(PCHLR)已被证明对治疗对疼痛药物、物理治疗和局部注射治疗无效的这种疾病表现有效。我们之前的研究表明了其一年的疗效和持久性,本研究检查了我们原始随机对照交叉队列的两年数据。

目的

强调评估 PCHLR 在 AC 管理中疗效的延长随访的重要性。

研究设计

前瞻性、随机、对照、交叉试验。

设置

学术医疗中心。

方法

我们的原始研究纳入了对口服药物、物理治疗和至少一次局部注射治疗无效的粘连性肩关节囊炎患者。最初共有 40 名患者(46 个肩部),其中 6 名患者使用 Tenex®系统接受了双侧 PCHLR。在这项前瞻性研究中,通过 2-1 块随机分组确定了实验组(计划接受 PCHLR)和对照组(计划在喙肱韧带中接受局部麻醉[LACHL])。最初接受治疗的 46 个肩部中,有 39 个在一年时仍留在研究中。39 个肩部中,26 个被分配到 PCHLR 组,13 个被分配到 LACHL 组。LACHL 组中的 13 个肩部中有 9 个交叉到 PCHLR 组。最终,31 个肩部留在 PCHLR 组进行两年分析。使用各种参数评估这些干预措施的效果。在手术前、一年和两年随访时评估疼痛评分、ROM 和牛津肩评分(OSS)。

结果

在这项为期两年的随访研究中,共抽取了 31 个肩部,包括 22 名女性和 5 名男性,4 名患者接受了双侧手术。患者的平均年龄为 65 岁(±11.48)。患者的平均体重指数(BMI)为 36.33(±6.55),CHL 厚度平均为 38.5(±3.45)。11 例存在骨关节炎。研究的平均随访时间为 29.7 个月(±6.39)。基线时平均外旋为 30°(±8),一年时增加到 62°(±18),两年时增加到 53°(±18)。基线时平均外展为 60°(±16),一年时增加到 77°(±21),两年时增加到 68°(±20)。中位数 NRS 从基线时的 8(IQR:8,9)下降到一年时的 3(IQR:2,7),两年时的 5(IQR:2,7)。基线中位数 OSS 为 7(IQR:3,10),一年时增加到 32,两年时增加到 22(IQR:15,35)。

局限性

本研究的患者样本量有限,均为因 CHL 增厚而导致 ROM 受损的患者。

结论

尽管粘连性肩关节囊炎的护理算法几十年来变化不大,但作者建议 PCHLR 是治疗对传统治疗无效的粘连性肩关节囊炎的一种安全、持久和有效的选择。

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