Focused electromagnetic high-energetic extracorporeal shockwave (ESWT) reduces pain levels in the nodular state of Dupuytren's disease-a randomized controlled trial (DupuyShock)
Abstract
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(2)/hand, Storz Duolith SD1, n = 27) or (group B) placebo ESWT (2000 shots, 3 Hz, 0.01 mJ/mm(2)/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).