Department of Family Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin 53715, USA.
Ann Fam Med. 2013 May-Jun;11(3):229-37. doi: 10.1370/afm.1504.
Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis.
Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used.
No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P <.01) at 52 weeks. Adjusted for sex, age, and body mass index, WOMAC scores for patients receiving dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events.
Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises.
膝骨关节炎是一种常见的、使人衰弱的慢性疾病。增生疗法是一种治疗慢性肌肉骨骼疼痛的注射疗法。我们进行了一项三臂、盲法(注射者、评估者、注射组参与者)、随机对照试验,以评估增生疗法治疗膝骨关节炎的疗效。
90 名至少有 3 个月膝关节骨关节炎疼痛的成年人被随机分为盲法注射(葡萄糖增生疗法或生理盐水)或家庭运动组。在 1、5 和 9 周进行关节内外注射,并在第 13 和 17 周按需进行额外治疗。运动组参与者接受运动手册和现场指导。主要结局包括 Western Ontario McMaster University Osteoarthritis Index(WOMAC;满分 100 分)综合评分、膝关节疼痛评分(KPS;单膝)、术后阿片类药物使用情况和患者满意度。采用方差分析的意向治疗分析。
各组之间在基线时没有差异。与基线相比,所有组在 52 周时报告的 WOMAC 综合评分均有改善(P<.01)。在调整性别、年龄和体重指数后,接受葡萄糖增生疗法的患者的 WOMAC 评分在 52 周时改善更明显(P<.05),高于接受生理盐水和运动的患者(评分变化:15.3±3.5 比 7.6±3.4 和 8.2±3.3 分),并超过了基于 WOMAC 的最小临床重要差异。在增生疗法组中,膝关节疼痛评分也有更大的改善(P=.05)。使用处方术后阿片类药物可迅速减轻注射相关疼痛。对增生疗法的满意度很高。无不良事件发生。
与盲法生理盐水注射和家庭运动相比,增生疗法可使膝骨关节炎的疼痛、功能和僵硬评分得到有临床意义的持续改善。