Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment
- Conditions
- Neuropathic Pain
- Interventions
- Registration Number
- NCT03348735
- Lead Sponsor
- University Hospital, Antwerp
- Brief Summary
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)).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 33
Not provided
- Age < 18;
- Pregnant and breastfeeding women;
- Infection in the painful skin region;
- Poorly healed or non-healed wound or scar in the painful skin region as well as presence of cutaneous abnormalities (non-intact skin barrier) within the painful skin region related to dermatological conditions;
- Known and/or strong suspicion of allergy to the study medication, known skin disorder (resulting in disruption of the normal skin barrier);
- Previous treatment with any of the three medications included in the study protocol for the same painful area within the last 12 months at the time of screening;
- Risk of heart failure and/or renal failure.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lidocaine patch 5% Lidocaine patch 5% Lidocaine 5% medicated plasters will be applied daily, during 12 consecutive hours. Capsaicin 8% patch Capsaicin 8% Patch Capsaicin 8% patches need to applied in a hospital setting during 1 hour. Re-application of these capsaicin patches will be performed upon re-occurrence of painful symptoms (mostly after 12 weeks - so not after a fixed time interval). Application of capsaicin patches will be carried out in a hospital setting (+/- 3 hours procedure). Pregabaline Pregabalin Oral treatment with pregabalin (75mg capsules) will be used at optimized doses to best match clinical practice in Europe. In European clinical practice, up-titration of the dose is often carried out over a longer time-period. This study thus includes up-titration schedule for pregabalin over a period of 4 weeks. If patients develop side-effects during the intake/uptitration of pregabalin this treatment can be stopped and switched to gabapentin (300mg capsules). Gabapentin will always be the back-up treatment for failed systematic treatment with pregabalin. Dose of gabapentin will be uptitrated to maximum 1200mg per day.
- Primary Outcome Measures
Name Time Method Health-related quality of life questionnaire 24 months 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.
- Secondary Outcome Measures
Name Time Method Pain relief from week 0 up to 26 weeks Reduction in pain intensity (PI-NRS), time to worsening of the pain (PI-NRS and NPSI) and use of rescue medication (MSQ III-R)
Drug tolerance from week 0 up to 26 weeks Percentage of patients without systemic drug related side effects, percentage of patients who discontinue the study drug.
Functional status of the patient from week 0 up to 26 weeks Impact of pain on functioning (Interference - BPI), participation in activities (Utrecht Work Engagement Scale), Work Productivity and Activity Impairment (WPAI).
Health-related quality of life from week 0 up to 26 weeks AUC for EQ-5D-5L measurements, global perceived effect (GPE), effect on mood (HADS), quality of sleep (NRS and ISI).
Trial Locations
- Locations (13)
AZ Klina
🇧🇪Brasschaat, Belgium
UZ Brussel
🇧🇪Jette, Belgium
Hopital Universitaire Sart Tilman de Liège (ULg) (CHU)
🇧🇪Liège, Belgium
AZ Sint Jan Brugge
🇧🇪Brugge, Belgium
Grand Hôpital de Charleroi
🇧🇪Charleroi, Belgium
University hospital Antwerp
🇧🇪Edegem, Antwerp, Belgium
AZ Monica (campus Antwerpen)
🇧🇪Antwerp, Belgium
UVC Brugmann
🇧🇪Brussels, Belgium
Ziekenhuis Oost-Limburg (ZOL
🇧🇪Genk, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
Universitair Ziekenhuis Leuven (UZL)
🇧🇪Leuven, Belgium
Universitair Ziekenhuis Gent (UZG)
🇧🇪Gent, Belgium
AZ Turnhout
🇧🇪Turnhout, Belgium