Rabago David, Patterson Jeffrey J, Mundt Marlon, Zgierska Aleksandra, Fortney Luke, Grettie Jessica, Kijowski Richard
1 Department of Family Medicine, University of Wisconsin School of Medicine and Public Health , Madison WI.
J Altern Complement Med. 2014 May;20(5):383-91. doi: 10.1089/acm.2013.0225. Epub 2014 Mar 17.
This study determined whether injection with hypertonic dextrose and morrhuate sodium (prolotherapy) using a pragmatic, clinically determined injection schedule for knee osteoarthritis (KOA) results in improved knee pain, function, and stiffness compared to baseline status.
This was a prospective three-arm uncontrolled study with 1-year follow-up.
The setting was outpatient.
The participants were 38 adults who had at least 3 months of symptomatic KOA and who were in the control groups of a prior prolotherapy randomized controlled trial (RCT) (Prior-Control), were ineligible for the RCT (Prior-Ineligible), or were eligible but declined the RCT (Prior-Declined).
The injection sessions at occurred at 1, 5, and 9 weeks with as-needed treatment at weeks 13 and 17. Extra-articular injections of 15% dextrose and 5% morrhuate sodium were done at peri-articular tendon and ligament insertions. A single intra-articular injection of 6 mL 25% dextrose was performed through an inferomedial approach.
The primary outcome measure was the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC). The secondary outcome measure was the Knee Pain Scale and postprocedure opioid medication use and participant satisfaction.
The Prior-Declined group reported the most severe baseline WOMAC score (p=0.02). Compared to baseline status, participants in the Prior-Control group reported a score change of 12.4±3.5 points (19.5%, p=0.002). Prior-Decline and Prior-Ineligible groups improved by 19.4±7.0 (42.9%, p=0.05) and 17.8±3.9 (28.4%, p=0.008) points, respectively; 55.6% of Prior-Control, 75% of Prior-Decline, and 50% of Prior-Ineligible participants reported score improvement in excess of the 12-point minimal clinical important difference on the WOMAC measure. Postprocedure opioid medication resulted in rapid diminution of prolotherapy injection pain. Satisfaction was high and there were no adverse events.
Prolotherapy using dextrose and morrhuate sodium injections for participants with mild-to-severe KOA resulted in safe, significant, sustained improvement of WOMAC-based knee pain, function, and stiffness scores compared to baseline status.
本研究旨在确定，对于膝关节骨关节炎（KOA）患者，采用务实的、临床确定的注射方案注射高渗葡萄糖和鱼肝油酸钠（注射疗法）与基线状态相比，是否能改善膝关节疼痛、功能和僵硬程度。
这是一项前瞻性的三臂非对照研究，随访1年。
门诊。
38名成年人，他们患有至少3个月有症状的KOA，且曾参与过注射疗法随机对照试验（RCT）的对照组（既往对照组）、不符合RCT条件（既往不符合条件组）或符合条件但拒绝参与RCT（既往拒绝组）。
在第1、5和9周进行注射疗程，并在第13和17周根据需要进行治疗。在关节周围肌腱和韧带附着处进行关节外注射15%葡萄糖和5%鱼肝油酸钠。通过内侧下入路进行一次6 mL 25%葡萄糖的关节内注射。
主要观察指标是经过验证的西安大略和麦克马斯特大学骨关节炎指数（WOMAC）。次要观察指标是膝关节疼痛量表、术后阿片类药物使用情况和参与者满意度。
既往拒绝组报告的基线WOMAC评分最高（p = 0.02）。与基线状态相比，既往对照组参与者报告的评分变化为12.4±3.5分（19.5%，p = 0.002）。既往拒绝组和既往不符合条件组分别改善了19.4±7.0分（42.9%，p = 0.05）和17.8±3.9分（28.4%，p = 0.008）；既往对照组中55.6%、既往拒绝组中75%和既往不符合条件组中50%的参与者报告WOMAC评分改善超过12分的最小临床重要差异。术后阿片类药物迅速减轻了注射疗法注射疼痛。满意度较高，且无不良事件。
对于轻至重度KOA患者，使用葡萄糖和鱼肝油酸钠注射的注射疗法与基线状态相比，能安全、显著且持续地改善基于WOMAC的膝关节疼痛、功能和僵硬评分。
