Latini Luca, Porta Francesco, Maccarrone Vincenzo, Zompa Davide, Cipolletta Edoardo, Mirza Riccardo Mashadi, Filippucci Emilio, Vreju Florentin Ananu
Centro Medico e Fisioterapia "Salute e Benessere"-Senigallia, 60019 Ancona, Italy.
Interdisciplinary Pain Medicine Unit, Rheumatology Section, Santa Maria Maddalena Hospital, Occhiobello, 45030 Rovigo, Italy.
Life (Basel). 2024 Oct 22;14(11):1351. doi: 10.3390/life14111351.
This study evaluates the clinical efficacy and safety of two ultrasound (US)-guided injections of a 5 mg/1 mL low-molecular-weight peptide (LWP) solution derived from hydrolyzed bovine collagen in patients with supraspinatus partial tendon tears.
A total of 21 patients with symptomatic partial tears of the supraspinatus tendon, detected by US, were consecutively enrolled and received one injection at a baseline visit (T0) and one after two weeks (T1). The primary outcome measure was the visual analogue scale (VAS) for pain. Secondary outcomes were the shoulder pain and disability index (SPADI) total score and the safety of LWP injections. Patients were examined at baseline (T0), at a week 2 follow-up visit (T1), and at a week 12 follow-up visit (T2).
A statistically significant improvement was found for both VAS pain and SPADI total scores, between T0 and T2 visits. US-guided injections were well tolerated and, apart from one patient with a progression of a tendon tear, no adverse events were recorded.
Intratendinous tear US-guided injection therapy with an LWP solution was found to be safe and effective in improving both pain and shoulder function at a 12-week follow-up visit. The present pilot study should be considered the first step justifying a larger confirmatory investigation.
本研究评估了超声(US)引导下两次注射5mg/1mL源自水解牛胶原蛋白的低分子量肽(LWP)溶液对冈上肌部分肌腱撕裂患者的临床疗效和安全性。
共有21例经超声检测出有症状的冈上肌腱部分撕裂患者连续入组,在基线访视(T0)时接受一次注射,两周后(T1)再接受一次注射。主要结局指标是疼痛视觉模拟量表(VAS)。次要结局指标是肩痛和功能障碍指数(SPADI)总分以及LWP注射的安全性。在基线(T0)、第2周随访访视(T1)和第12周随访访视(T2)时对患者进行检查。
在T0和T2访视之间,VAS疼痛评分和SPADI总分均有统计学意义的改善。超声引导下的注射耐受性良好,除1例患者肌腱撕裂进展外,未记录到不良事件。
在12周的随访中,发现US引导下向肌腱内注射LWP溶液在改善疼痛和肩部功能方面是安全有效的。本初步研究应被视为开展更大规模验证性研究的第一步。