Malmgaard-Clausen Nikolaj M, Jørgensen Oscar H, Høffner Rikke, Andersen Peter E B, Svensson Rene B, Hansen Philip, Nybing Janus D, Magnusson S Peter, Kjær Michael
Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
Center for Healthy Aging, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
Am J Sports Med. 2021 Jun;49(7):1711-1720. doi: 10.1177/0363546521991903. Epub 2021 Mar 15.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used in the treatment of Achilles tendinopathy, but whether they have any additive clinical effect on physical rehabilitation in the early phase of tendinopathy remains unknown.
PURPOSE/HYPOTHESIS: To investigate whether an initial short-term NSAID treatment added to a physical rehabilitation program in the early phase of Achilles tendinopathy would have an additive effect. We hypothesized that the combination of NSAID and rehabilitation would be superior to rehabilitation alone.
Randomized controlled trial; Level of evidence, 1.
A total of 69 patients with early phase Achilles tendinopathy (lasting <3 months) were randomly assigned to either a naproxen group (7 days of treatment; 500 mg twice daily; n = 34) or a placebo group (7 days of placebo treatment; n = 35). Both groups received an identical 12-week physical rehabilitation program. The clinical outcome of the study was evaluated using the Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire and a numerical rating scale (NRS), and the physiological outcome was evaluated using ultrasonography, magnetic resonance imaging (MRI), and ultra-short time to echo T2* mapping MRI (UTE T2* MRI). Follow-up was performed at 1 week, 3 months, and 1 year. Time effects are presented as mean difference ± SEM.
No significant differences were found between the 2 treatment groups for any of the outcome measures at any time point ( > .05). For the VISA-A score, a significant time effect was observed between baseline and 3-month follow-up (14.9 ± 2.3; < .0001), and at 1-year follow-up, additional improvements were observed (6.1 ± 2.3; < .01). Furthermore, the change in VISA-A score between baseline and 3-month follow-up was greater in patients with very short symptom duration (<1 month) at baseline compared with patients who had longer symptom duration (>2 months) (interaction between groups, 11.7 ± 4.2; < .01). Despite clinical improvements, total weekly physical activity remained lower compared with preinjury levels at 3 months (-2.7 ± 0.5 h/wk; < .0001) and 1 year (-3.0 ± 0.5 h/wk; < .0001). At baseline, ultrasonography showed increased thickness (0.12 ± 0.03 cm; < .0001) and vascularity (0.3 ± 0.1 cm; < .005) on the tendinopathic side compared with the contralateral side, but no changes over time were observed for ultrasonography, MRI, or UTE T2* MRI results.
Clinical symptoms in early tendinopathy improved with physical rehabilitation, but this improvement was not augmented with the addition of NSAID treatment. Furthermore, this clinical recovery occurred in the absence of any measurable structural alterations. Finally, clinical improvements after a physical rehabilitation program were greater in patients with very short symptom duration compared with patients who had longer symptom duration.
NCT03401177 (ClinicalTrials.gov identifier) and BFH-2016-019 (Danish Data Protection Agency).
非甾体抗炎药（NSAIDs）常用于治疗跟腱病，但它们在跟腱病早期对物理康复是否具有任何附加临床效果仍不清楚。
目的/假设：研究在跟腱病早期，在物理康复计划基础上增加初始短期NSAIDs治疗是否会有附加效果。我们假设NSAIDs与康复治疗相结合将优于单纯康复治疗。
随机对照试验；证据等级，1级。
总共69例早期跟腱病患者（病程<3个月）被随机分配至萘普生组（治疗7天；每日2次，每次500mg；n = 34）或安慰剂组（安慰剂治疗7天；n = 35）。两组均接受相同的为期12周的物理康复计划。使用维多利亚运动评估-跟腱（VISA-A）问卷和数字评分量表（NRS）评估研究的临床结局，使用超声、磁共振成像（MRI）和超短回波时间T2映射MRI（UTE T2 MRI）评估生理结局。在1周、3个月和1年时进行随访。时间效应以平均差值±标准误表示。
在任何时间点，两个治疗组之间的任何结局指标均未发现显著差异（P>.05）。对于VISA-A评分，在基线和3个月随访之间观察到显著的时间效应（14.9±2.3；P<.0001），并且在1年随访时，观察到进一步改善（6.1±2.3；P<.01）。此外，与症状持续时间较长（>2个月）的患者相比，基线时症状持续时间非常短（<1个月）的患者在基线和3个月随访之间VISA-A评分的变化更大（组间交互作用，11.7±4.2；P<.01）。尽管临床症状有所改善，但在3个月（-2.7±0.5 h/周；P<.0001）和1年（-3.0±0.5 h/周；P<.0001）时，每周的总体力活动仍低于受伤前水平。在基线时，超声显示患侧跟腱厚度增加（0.12±0.03 cm；P<.0001）和血管形成增加（0.3±0.1 cm；P<.005），与对侧相比，但超声、MRI或UTE T2* MRI结果未观察到随时间的变化。
早期跟腱病的临床症状通过物理康复得到改善，但添加NSAIDs治疗并未增强这种改善。此外，这种临床恢复是在没有任何可测量的结构改变的情况下发生的。最后，与症状持续时间较长的患者相比，症状持续时间非常短的患者在物理康复计划后的临床改善更大。
NCT03401177（ClinicalTrials.gov标识符）和BFH-2016-019（丹麦数据保护局）。
