• Giannapia Affaitati, Alessandra Fabrizio, Valeria Frangione, Arturo Lanzarotti, Mariangela Lopopolo, Emmanuele Tafuri, Domenico Lapenna, Maria Adele Giamberardino, and Raffaele Costantini.
• Ce.S.I., "G. D'Annunzio" Foundation, Chieti, Italy; Department of Medicine and Science of Aging, University of Chieti, Chieti, Italy.
• Pain Pract. 2015 Jan 1; 15 (1): 58-67.

ObjectiveTo evaluate whether a diclofenac epolamine + heparin topical (plaster) is more effective than diclofenac plaster alone in reducing deep somatic hyperalgesia in subjects without spontaneous pain and whether the effect is linked to or independent of the anti-edematous action of heparin.DesignProspective, double-blind, randomized and controlled, four-arm parallel design trial.SubjectsOne hundred and four patients (84 women, 20 men, mean age 42.2 ± 13.3 years), with deep somatic hyperalgesia in one thigh, randomly assigned to one of 4 groups of 26 each.InterventionEach group underwent one of the following plaster treatments on one thigh: diclofenac+heparin; diclofenac; heparin; placebo, for 7 days, renewing the plaster every 24 hours.Outcome MeasuresBefore treatment (day 1), at day 4 and day 8, assessment of (a) pressure and electrical pain thresholds of vastus lateralis and overlying subcutis and skin; and (b) structure/thickness of subcutis and muscle with ultrasounds at the same level.ResultsDuring treatment, in placebo and heparin, no significant threshold changes, except subcutis thresholds which increased slightly (P < 0.02); in diclofenac and diclofenac+heparin, significant increase in all thresholds (0.0001 < P < 0.04). Electrical muscle pain thresholds increased significantly more in diclofenac+heparin than in diclofenac, heparin, and placebo (0.0001 < P < 0.04). In all groups: no edema and thickness changes at ultrasounds in muscle and subcutis.ConclusionsTopical diclofenac+heparin is significantly more effective than diclofenac alone in reducing muscle hyperalgesia in subjects without spontaneous pain, independently of the anti-edematous action of heparin. The results provide a rationale for the use of diclofenac+heparin also in algogenic conditions without evident signs of injury/edema/hematoma.© 2014 World Institute of Pain.

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