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Online ISSN 1827-1707
Roberta LUZZI, Gianni BELCARO, Mark DUGALL
Irvine3 Labs, Circulation Sciences, University G. d’Annunzio, Chieti, Italy
BACKGROUND: The aim of this registry study was to evaluate a new device, a thin soft, flexible, transdermal patch including Pycnogenol® in otherwise healthy, self-medicating patients with neck pain. Idiopatic, benign, transient neck pain (IBTNP) is usually localized at the back, often asymmetrical. 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 2 weeks: the patches were applied on the neck, close to the painful area. The clinical evaluation considered subjective measurements of four main symptoms (present in all subjects at inclusion): pain, stiffness, altered mobility, altered working capacity. The intensity of each symptom was scored on a visual analogue scale line.
RESULTS: Compliance and tolerability to the patch were optimal. No side effect or tolerability problem was observed, no allergic reaction was noted. At inclusion, the 26 controls and 32 patients using the patches (19 women) were comparable for age, sex distribution and for their clinical symptoms. The intensity of the four scored items was comparable in the two groups at inclusion. There was a significant decrease in these symptoms at one week in both groups (with a significant prevalence for the Pycnogenol® patch) and a significantly higher variation (decrease in symptoms) at week 2 in the Pycnogenol® group (P<0.05). In the Pycnogenol® group only 3 patients (9.37%) had to use another medical treatment (NSAIDs) during the follow up. Among controls, 8 patients out of 26 (30.76%) had to use another treatment (P<0.05). At two weeks, 2 out of 32 patients (6.25%) had only (minimal) residual pain in comparison with 6 out of 26 among controls (23.07%).
CONCLUSIONS: Neck pain (including symptoms localized at the lower neck and higher back) affects, possibly, some 4.9% of the population in industrial countries). About 60% of these painful episodes completely resolve within one year in subjects without any other significant clinical problem. The frequency of neck pain, and the relative difficulty or impossibility to work and have an active life, induces high medical and social costs. This pilot study shows that a thin Pycnogenol® patch may control symptoms and produce a faster healing and may be a significant non-prescription option for self-medication.