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肩峰下注射透明质酸钠对肩袖疾病的影响:一项双盲安慰剂对照临床试验。

Effect of subacromial sodium hyaluronate injection on rotator cuff disease: A double-blind placebo-controlled clinical trial.

作者信息

Moghtaderi Alireza, Sajadiyeh Sepideh, Khosrawi Saeid, Dehghan Farnaz, Bateni Vahid

机构信息

Department of Physical Medicine and Rehabilitation, Medical University of Isfahan, Isfahan, Iran.

Department of Radiology, Medical University of Isfahan, Isfahan, Iran.

出版信息

Adv Biomed Res. 2013 Nov 30;2:89. doi: 10.4103/2277-9175.122517. eCollection 2013.

DOI:10.4103/2277-9175.122517
PMID:24524035
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3908695/
Abstract

BACKGROUND

Rotator cuff disease is a common cause of shoulder pain. There are studies about the effectiveness of sodium hyaluronate injection on shoulder and knee pain, but few studies demonstrating the efficacy of sodium hyaluronate ultrasonography guided injection for rotator cuff disease. This study evaluates effectiveness of ultrasonography guided subacromial sodium hyaluronate injection in patients with impingment syndrome without rotator cuff complete tear.

MATERIALS AND METHODS

This prospective, double-blind, placebo controlled clinical trial study was performed among 40 patients with subacromial impingement syndrome without complete tear of rotator cuff. Patients randomly injected ultrasonography guided in 2 groups: Case group by 20 mg of sodium hyaluronate (Fermathron™) and control group by 0.9% normal saline. Both groups received 3 weekly injections. The pain score (100 mm visual analogue score [VAS]) was evaluated before first injection and one week after each injection. The constant score was evaluated before first and 12 week after last injection. Data was analyzed statistically by Independent t-test.

RESULTS

In both groups mean VAS has decreased, but more significantly in case group (P < 0.001). Mean constant score was significantly higher in case group 12 weeks after last injection (P < 0.001). The constant score improved 12 weeks after the last injection in both groups with a significantly better result in case group (P < 0.001).

CONCLUSION

Subacromial injections of sodium hyaluronate are effective in treating rotator cuff disease without complete tears.

摘要

背景

肩袖疾病是肩部疼痛的常见原因。有关于透明质酸钠注射治疗肩部和膝部疼痛有效性的研究,但很少有研究证明超声引导下透明质酸钠注射治疗肩袖疾病的疗效。本研究评估超声引导下肩峰下注射透明质酸钠对无肩袖完全撕裂的撞击综合征患者的有效性。

材料与方法

本前瞻性、双盲、安慰剂对照临床试验研究在40例无肩袖完全撕裂的肩峰下撞击综合征患者中进行。患者随机分为两组,在超声引导下注射:病例组注射20mg透明质酸钠(Fermathron™),对照组注射0.9%生理盐水。两组均每周注射3次。在首次注射前和每次注射后1周评估疼痛评分(100mm视觉模拟评分[VAS])。在首次注射前和最后一次注射后12周评估Constant评分。数据采用独立t检验进行统计学分析。

结果

两组的平均VAS均有所下降,但病例组下降更显著(P<0.001)。最后一次注射后12周,病例组的平均Constant评分显著更高(P<0.001)。两组在最后一次注射后12周Constant评分均有所改善,病例组结果明显更好(P<0.001)。

结论

肩峰下注射透明质酸钠对治疗无完全撕裂的肩袖疾病有效。

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