Introduction
Hypothesis of this RCT
Methods
Ethics and trial design
Study design
Participants
Variable | Intervention group (N = 27) | Placebo group (N = 25) | All patients (N = 52) | P value |
---|---|---|---|---|
Age—yr | 57.6 ± 8.1 | 58.9 ± 10.9 | 58.2 ± 9.5 | 0.4254+ |
Male sex—no. (%) | 15 (55.6) | 17 (68) | 35 (61.5) | 0.35674* |
Hand with ≥1 knot—no. (%) | 0.7258 | |||
Left | 20 (74.1) | 18 (72) | 38 (73.1) | 0.86621* |
Right | 25 (92.6) | 19 (76) | 44 (84.6) | 0,09754* |
Both | 18 (66.7) | 12 (48) | 30 (57.7) | 0,17,342* |
Number of knots | 2.3 ± 1.1 | 2.4 ± 0.9 | 2.3 ± 1.0 | 0.9848* |
Family history of Dupuytrens disease—no. (%) | 9 (33.3) | 8 (32) | 17 (32.7) | 0.91843* |
Risk factors and associated conditions—no. (%) | ||||
Exposure to vibration | 0 (0) | 1 (4) | 1 (1.9) | 0.29401* |
Hand-affecting job | 14 (51.9) | 9 (36) | 23 (44.2) | 0.25017* |
Hand-affecting sports | 5 (18.5) | – | ||
Hand trauma | 1 (3.7) | 5 (20) | 6 (11.5) | 0.06610* |
Knuckle pads | 1 (3.7) | 0 (0) | 1 (1.9) | 0.33123* |
Peyronie’s disease | 2 (7.4) | 0 (0) | 2 (3.8) | 0.16520* |
Ledderhose’s disease | 6 (22.2) | 1 (4) | 7 (13.5) | 0,05441* |
Diabetes | 2 (7.2) | 2 (8) | 4 (7.7) | 0.93614* |
Epilepsy | 0 (0) | 0 (0) | 0 (0) | 1.0* |
History of cancer | 2 (7.4) | 1 (4) | 3 (5.8) | 0.59852* |
Alcohol abuse | 0 (0) | 1 (4) | 1 (1.9) | 0.29401* |
Tobacco use | 0 (0) | 2 (8) | 2 (3.8) | 0.13393* |
Initial diagnose—month ago | ||||
Mean | 36.4 ± 55.8 | 43 ± 40.3 | 39.6 ± 48.6 | 0.2444+ |
Range | 3–264 | 4–144 | 3–264 | – |
Current medication—no. (%) | ||||
Antihypertensive medication | 6 (22.2) | 4 (16) | 10 (19.2) | 0.56948* |
Acetylcystein (ACC) treatment | 3 (11.1) | 2 (8) | 5 (9.6) | 0.70378* |
Previous treatment for Dupuytren’s disease—no. (%) | ||||
None | 19 (70.4) | 18 (72) | 37 (71.2) | 0.89689* |
Surgery | 3 (11.1) | 5 (20) | 8 (15.4) | 0.37474* |
Hand therapy | 5 (18.5) | 2 (8) | 7 (13.4) | 0.26686* |
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Tubiana stage 0: no lesion
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Tubiana stage N: palmar or digital nodule without established flexion deformity
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Tubiana stage 1: total flexion deformity between 0° and 45°
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Tubiana stage 2: total flexion deformity between 46° and 90°
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Tubiana stage 3: total flexion deformity between 91° and 135°
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Tubiana stage 4: total flexion deformity exceeding 135°
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Eligible patients are patients aged 18 or over and 80 or younger
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Painful Dupuytren’s disease of Tubiana stage N (nodular) and 1 involving one or more fingers or the palm only
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Exclusion criteria are suspected or evident pregnancy
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No painful Dupuytren’s disease
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Evident ulcerations
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No informed consent
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Age under 18 years or above 80 years
Interventions
Energy levels in focused extracorporeal shockwave therapy
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Electrohydraulic generator
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Electromagnetic generator
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Piezoelectric generator
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Very low/nano energetic 0.01–0.05 mJ/mm2
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Low energetic 0.07–0.1 mJ/mm2
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Medium energetic 0.1–0.25 mJ/mm2
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High energetic >0.25 mJ/mm2
Primary and secondary end points and assessments
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An improvement of function measured with self-reported hand function and disability assessed by the Disabilities of Arm Shoulder and Hand Questionnaire (DASH).
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A change of the patient-related outcome measure Michigan Hand questionnaire (MHQ)
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A change of the patient-related outcome measure URAM [32]
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Hand grip strength [kg] was measured using a JAMAR dynamometer in three repetitions on each hand with elbow fully extended prior to every treatment and after the third treatment
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Patient satisfaction and progression of Dupuytren’s disease
Safety assessments
Statistical analysis
Results
Primary endpoint pain in Dupuytren’s nodules
Secondary endpoints in Dupuytren’s nodules
DASH score
MHQ
URAM scale
Grip strength
Strength before and after | Intervention group (n = 27) | Control group (n = 25) |
---|---|---|
Grip strength Jamar | 37 ± 12 vs. 37 ± 13 kg (n.s.) | 39 ± 14 vs. 40 ± 14 kg (n.s.) |
Pinch strength | 9 ± 3 vs. 9 ± 3 kg (n.s.) | 9 ± 3 vs. 10 ± 3 kg (n.s.) |
Patient satisfaction
Intervention group (n = 27) | Control group (n = 25) | |
---|---|---|
Improvement of symptoms | 56% | 12% |
Any Dupuytren intervention in 18 months | 25.9% (n = 7) | 36% (n = 9) |
Surgery | 18.5% (n = 5) | 28% (n = 7) |
Percutaneous needle fasciotomy (PNF) | 3.7% (n = 1) | 8% (n = 2) |
Collagenase clostridium histolyticum | 3.7% (n = 1) | 0 |