Evaluation of topical treatment with lidocaine 5% patch (daily administration) or capsaicin 8% patch (periodic administration - upon reoccurrence of pain symptoms) in adult patients suffering from localized neuropathic pain (LNP) across a wide variety of etiologies, with a duration between 1 and 24 months (subacute to chronic neuropathic pain (NP)).
A multicentre, randomized, open-label comparative trial evaluating topical treatment options versus oral systemic treatment in adult patients suffering from localized neuropathic pain (LNP) syndromes. A wide variety of peripheral neuropathic pain syndromes will be included such as post-herpetic neuralgia (PHN), post-surgical NP/post-traumatic NP/scar pain, post-amputation NP, post-radiation therapy NP, complex regional pain syndrome (CRPS) type 1. In contrast to most (or even all) commercial clinical studies we will not limit the inclusion to one or two distinct neuropathic pain syndromes such as post-herpetic neuralgia (inclusion based on etiology of the neuropathic syndrome). In this pragmatic trial we will however include all patients suffering from a clinical neuropathic syndrome with distinct clinical features such as hyperalgesia/allodynia, presence of spontaneous positive sensory phenomena and lasting for more than 3 months without making any exclusion based on etiology. Initial pain intensity indicates the presence of either moderate or severe pain in these adult patients (NRS 4/10).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
Application of Lidocaine 5% patch for 12 hours.
Application of Capsaicin 8% patch for
Oral treatment with pregabalin (75mg capsules) will be used at optimized doses to best match clinical practice in Europe.
University hospital Antwerp
Edegem, Antwerp, Belgium
AZ Monica (campus Antwerpen)
Antwerp, Belgium
AZ Klina
Brasschaat, Belgium
Health-related quality of life questionnaire
To determine if topical treatment significantly improves health-related quality of life compared to systemic treatment in adult patients suffering from localized neuropathic pain across a wide variety of etiologies (LNP), with a duration between 1 and 24 months.
Time frame: 24 months
Pain relief
Reduction in pain intensity (PI-NRS), time to worsening of the pain (PI-NRS and NPSI) and use of rescue medication (MSQ III-R)
Time frame: from week 0 up to 26 weeks
Health-related quality of life
AUC for EQ-5D-5L measurements, global perceived effect (GPE), effect on mood (HADS), quality of sleep (NRS and ISI).
Time frame: from week 0 up to 26 weeks
Drug tolerance
Percentage of patients without systemic drug related side effects, percentage of patients who discontinue the study drug.
Time frame: from week 0 up to 26 weeks
Functional status of the patient
Impact of pain on functioning (Interference - BPI), participation in activities (Utrecht Work Engagement Scale), Work Productivity and Activity Impairment (WPAI).
Time frame: from week 0 up to 26 weeks
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AZ Sint Jan Brugge
Bruges, Belgium
UVC Brugmann
Brussels, Belgium
Grand Hôpital de Charleroi
Charleroi, Belgium
Ziekenhuis Oost-Limburg (ZOL
Genk, Belgium
Universitair Ziekenhuis Gent (UZG)
Ghent, Belgium
UZ Brussel
Jette, Belgium
Universitair Ziekenhuis Leuven (UZL)
Leuven, Belgium
...and 3 more locations