Context/Objectives

Wheelchair users with chronic shoulder pain have few options after conservative treatments fail. This pilot study’s purpose was to establish safety and treatment effects of micro-fragmented adipose tissue (MFAT) injections under ultrasound guidance for treatment of refractory shoulder pain caused by rotator cuff disease in wheelchair users with spinal cord injury (SCI) to prepare for a larger trial.

Design

Pilot clinical trial.

Setting

Rehabilitation hospital outpatient clinic.

Participants

Ten wheelchair users with chronic SCI who had moderate-to-severe shoulder pain caused by refractory rotator cuff disease (diagnosed via ultrasound) for greater than 6 months.

Interventions

Ultrasound-guided injections of MFAT into the pathologic rotator cuff tendons and other abnormal shoulder structures (e.g. acromioclavicular and glenohumeral joints; subacromial bursa).

Outcome Measures

6- and 12-month changes in 11-point Numerical Rating Scale (NRS); Wheelchair User’s Shoulder Pain Index (WUSPI); Brief Pain Inventory pain interference items (BPI-I7); Patient Global Impression of Change (PGIC); ultrasound and physical exams; and adverse events.

Conclusions

There were no significant adverse events throughout the study period. WUSPI, NRS, and BPI-I7 scores were significantly lower 6 and 12 months post-procedure (P < .05). Of those who remained in the trial, clinically meaningful changes (≥30% decrease) in WUSPI, NRS, and BPI-I7 scores were observed in 77.8%, 77.8%, and 66.7% of participants, respectively. All but one participant reported improvement in clinical status. MFAT injection under ultrasound guidance is potentially a safe and efficacious treatment for refractory shoulder pain caused by rotator cuff disease in wheelchair users with SCI. A larger, randomized controlled trial has been initiated.

Trial registration: ClinicalTrials.gov identifier: NCT03167138

中文翻译：

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超声引导下微碎脂肪组织注射治疗脊髓损伤轮椅使用者难治性肩袖疾病的初步研究

背景/目标

在保守治疗失败后，患有慢性肩痛的轮椅使用者几乎没有选择。本试验性研究的目的是确定超声引导下微碎脂肪组织 (MFAT) 注射治疗脊髓损伤 (SCI) 轮椅使用者肩袖疾病引起的难治性肩痛的安全性和治疗效果，为更大范围的治疗做准备。审判。

设计

试点临床试验。

环境

康复医院门诊。

参与者

10 名患有慢性 SCI 的轮椅使用者，他们因难治性肩袖疾病（通过超声诊断）导致中度至重度肩痛超过 6 个月。

干预措施

超声引导下将 MFAT 注射到病理性肩袖肌腱和其他异常肩部结构（例如肩锁关节和盂肱关节；肩峰下囊）。

结果测量

11 点数值评定量表 (NRS) 的 6 个月和 12 个月变化；轮椅使用者肩痛指数 (WUSPI)；Brief Pain Inventory 疼痛干扰项目（BPI-I7）；患者全球变化印象（PGIC）；超声波和身体检查；和不良事件。

结论

在整个研究期间没有发生明显的不良事件。WUSPI、NRS 和 BPI-I7 评分在术后 6 个月和 12 个月显着降低 (P < .05)。在继续参与试验的参与者中，分别有 77.8%、77.8% 和 66.7% 的参与者观察到 WUSPI、NRS 和 BPI-I7 评分有临床意义的变化（降低 30% 以上）。除一名参与者外，所有参与者都报告了临床状况的改善。超声引导下 MFAT 注射可能是治疗 SCI 轮椅使用者肩袖疾病引起的难治性肩痛的一种安全有效的治疗方法。一项更大的随机对照试验已经启动。

试验注册：ClinicalTrials.gov 标识符：NCT03167138