Focused electromagnetic high-energetic extracorporeal shockwave (ESWT) reduces pain levels in the nodular state of Dupuytren's disease-a randomized controlled trial (DupuyShock)

Karsten Knobloch, Marie Hellweg, Heiko Sorg, Tomas Nedelka, Karsten Knobloch, Marie Hellweg, Heiko Sorg, Tomas Nedelka

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/mm2/hand, Storz Duolith SD1, n = 27) or (group B) placebo ESWT (2000 shots, 3 Hz, 0.01 mJ/mm2/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).

Keywords: Dupuytren; ESWT; Nodule; Pain; Shockwave; Therapy.

Conflict of interest statement

MK, HS, and TN have nothing to declare. KK received honoraries for lectures for Storz Medical AG after completion of the trial, which do not have any impact on the results presented herein.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
CONSORT flow chart
Fig. 2
Fig. 2
Schematic pressure profile of a focused extracorporeal shockwave (ESWT)
Fig. 3
Fig. 3
Energy flux densities (EFD measured in mJ/mm2) as low energetic (<0.1 mJ/mm2), medium energetic (0.1–0.25 mJ/mm2), and high energetic (>0.25 mJ/mm2)
Fig. 4
Fig. 4
Group A with three consecutive sessions of high-energetic focused electromagnetic extracorporeal shock wave therapy (focused ESWT) vs. group B with three sessions of SHAM-ESWT on a weekly base
Fig. 5
Fig. 5
Change of pain level on visual analogue scale (VAS) after 3, 6, 12, and 18 months in the high-energetic electromagnetic focused ESWT group A (white, 0.35 mJ/mm2, 3 sessions) vs. SHAM-ESWT group B (black, 0.01 mJ/mm2, 3 sessions)
Fig. 6
Fig. 6
Change of DASH scores after 3, 6, 12, and 18 months in the high-energetic electromagnetic focused ESWT group A (white, 0.35 mJ/mm2, 3 sessions) vs. SHAM-ESWT group B (black, 0.01 mJ/mm2, 3 sessions)
Fig. 7
Fig. 7
Change of MHQ scores after 3, 6, 12, and 18 months in the high-energetic electromagnetic focused ESWT group A (white, 0.35 mJ/mm2, 3 sessions) vs. SHAM-ESWT group B (black, 0.01 mJ/mm2, 3 sessions)
Fig. 8
Fig. 8
Potential antifibrotic effect of focused EWST modulating the TGF-beta receptor which drives the pro-fibrotic pathway via the Smad 2/3 pathway

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