Plastic, Hand and Reconstructive Surgery, Hannover Medical School, Hannover, Germany.
SportPraxis Prof. Dr. Karsten Knobloch, Heiligerstr. 3, 30159, Hannover, Germany.
Lasers Med Sci. 2022 Feb;37(1):323-333. doi: 10.1007/s10103-021-03254-9. Epub 2021 Jan 23.
Dupuytren's disease is a progressive fibroproliferative disorder of the hand. In the nodular stage of Dupuytren's disease, pain might limit daily hand activities and progress to finger contractures. Focused electromagnetic high-energetic extracorporeal shockwave therapy (ESWT) may reduce pain in Dupuytren's nodules (Tubiana N). In this prospective, randomized, blinded, placebo-controlled single center trial, we enrolled 52 patients (mean age, 58.2 ± 9.2) with painful nodular Dupuytren disease Tubiana N. Randomization was done to either (group A) 3 treatments with focused electromagnetic high-energetic ESWT (2000 shots, 3 Hz, 0.35 mmJ/mm/hand, Storz Duolith SD1, n = 27) or (group B) placebo ESWT (2000 shots, 3 Hz, 0.01 mJ/mm/hand, n = 25) in a weekly interval. Primary outcome was the level of pain on a visual analogue scale (VAS 0-10) at 3/6/12/18 months, secondary outcomes were patient-related outcome measures (DASH score, MHQ score, URAM scale), grip strength, patient's satisfaction, and Dupuytren's disease progression over 18 months follow-up. Focused ESWT significantly improved outcomes. Pain was reduced from 3.6 ± 1.8 to 1.9 ± 1.2 at three, to 1.4 ± 0.7 at six, to 1.7 ± 1.6 after 12 months and 1.9 ± 0.8 after 18 months in the intervention group (47% reduction, p < 0.05). In the placebo group, pain on VAS increased from 2.2 ± 1.4 to 3.4 ± 1.7 at three, to 3.4 ± 1.8 at six, to 3.4 ± 1.4 at 12 and 3.1 ± 1.1 at 18 months (35% increase, p < 0.05). Quality-of-life score tended to improve in the intervention group (MHQ, 77 ± 19 to 83 ± 12; DASH, 12 ± 18 to 10 ± 9) while it deteriorated in the placebo group as Dupuytren's disease was progressing (MHQ, 79 ± 15 to 73 ± 17; DASH, 6 ± 10 to 14 ± 13). The strength of the affected hand and fingers did not change significantly in either of the groups. Patients' satisfaction was higher in the intervention group for symptom improvement (56% vs. 12%) and reduction of disease progression (59% vs. 24%). Any Dupuytren-related intervention was performed in 26% in the intervention group and in 36% in the placebo group within 18 months of follow-up (n.s.). Focused electromagnetic high-energetic ESWT can significantly reduce pain in painful nodules in Dupuytren's disease in an 18-month perspective. ( ClinicalTrials.gov Identifier: NCT01184586).
掌腱膜挛缩症是一种手部进行性纤维增生性疾病。在掌腱膜挛缩症的结节期，疼痛可能会限制日常手部活动，并进展为手指挛缩。聚焦电磁高能量体外冲击波治疗（ESWT）可能会减轻掌腱膜挛缩结节（Tubiana N）的疼痛。在这项前瞻性、随机、盲法、安慰剂对照的单中心试验中，我们招募了 52 名（平均年龄 58.2±9.2）患有疼痛性结节性掌腱膜挛缩症 Tubiana N 的患者。将他们随机分为两组：（A 组）接受聚焦电磁高能量 ESWT（2000 次，3 Hz，0.35 mmJ/mm/手，Storz Duolith SD1，n=27）或（B 组）接受安慰剂 ESWT（2000 次，3 Hz，0.01 mJ/mm/手，n=25），每周一次。主要结局是治疗后 3/6/12/18 个月时视觉模拟评分（VAS 0-10）的疼痛程度，次要结局是患者相关的结果测量（DASH 评分、MHQ 评分、URAM 量表）、握力、患者满意度以及 18 个月随访期间的掌腱膜挛缩进展情况。聚焦 ESWT 显著改善了结果。疼痛从治疗前的 3.6±1.8 分别降至治疗后 3 个月时的 1.9±1.2、6 个月时的 1.4±0.7、12 个月时的 1.7±1.6 和 18 个月时的 1.9±0.8（降低 47%，p<0.05）。在安慰剂组中，VAS 疼痛从治疗前的 2.2±1.4 分别增加到治疗后 3 个月时的 3.4±1.7、6 个月时的 3.4±1.8、12 个月时的 3.4±1.4 和 18 个月时的 3.1±1.1（增加 35%，p<0.05）。干预组的生活质量评分（MHQ，77±19 至 83±12；DASH，12±18 至 10±9）有改善趋势，而安慰剂组随着掌腱膜挛缩的进展（MHQ，79±15 至 73±17；DASH，6±10 至 14±13）而恶化。两组患者的手部和手指握力均无明显变化。干预组患者对症状改善（56%比 12%）和疾病进展减少（59%比 24%）的满意度更高。在 18 个月的随访期间，干预组中有 26%的患者和安慰剂组中有 36%的患者接受了任何与掌腱膜挛缩相关的治疗（无统计学意义）。聚焦电磁高能量 ESWT 可在 18 个月的时间内显著减轻掌腱膜挛缩结节的疼痛。（临床试验注册编号：NCT01184586）
