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MINERVA ORTOPEDICA E TRAUMATOLOGICA
Rivista di Ortopedia e Traumatologia
Minerva Ortopedica e Traumatologica 2016 December;67(4):170-6
Moderate, diffuse, somatic muscular pain: effects of supplementation with a Pycnogenol® patch
Roberta LUZZI 1, 2, Gianni BELCARO 1, 2, Beatrice FERAGALLI 1, 2, Mark DUGALL 1, 2
1 Irvine3 Labs, Chieti, Italy; 2 Circulation Sciences, D’Annunzio University, Chieti, Italy
BACKGROUND: The aim of this registry study was to evaluate a new device, a flexible, transdermal patch including Pycnogenol® in self-medicating patients with idiopathic somatic pain. Pycnogenol®, extracted from the bark of a specific French Maritime pine, is a highly standardized, anti-inflammatory supplement, effective for pain management in several clinical conditions.
METHODS: Two patches were used every day for 4 weeks. The clinical evaluation considered subjective and objective measurements (including pain threshold): pain, stiffness, altered mobility, altered working capacity, hand strength and grip, efforts associated with pain, pain threshold (evaluated with a dynamometer and a pressure cuff) and oxidative stress.
RESULTS: After 4 weeks of use, compliance and tolerability to the patch were optimal. No side effect or tolerability problem occurred during the study. At inclusion the two groups, including 24 controls and 28 subjects using the patch were comparable. The scored items were comparable for intensity and distribution in the two groups at inclusion. There was a general improvement in these symptoms at 4 weeks in both groups (with a significant prevalence in improvement for the patch group) (P<0.05). Only four patients using the patch (out of 28) had to use another medical treatment (NSAIDs) during the follow up to control pain. In the control group, 12 patients out of 24 had to use another treatment (10 used NSAIDs and 6 physiotherapy). This difference was statistically significant (P<0.05). At 4 weeks in this registry 14 out of 24 controls (50%) were asymptomatic; in comparison in the patch group 24 out of 28 patients were without symptoms.
CONCLUSIONS: The frequency of somatic/muscular pain — and the relative difficulty or impossibility to work regularly and have an active life — is cause of high medical and social costs. This pilot study shows that a self-management with a Pycnogenol® patch may control most symptoms, produces a faster healing and may be a significant non-prescription option for self-medication.