Neuropathic Pain
Conditions
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).
Interventions
Application of Lidocaine 5% patch for 12 hours.
Application of Capsaicin 8% patch for
DRUGPregabalin
Oral treatment with pregabalin (75mg capsules) will be used at optimized doses to best match clinical practice in Europe.
Sponsors
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Stratified randomization by site and Neuropathic Pain Symptom Inventory (NPSI) will be applied, and coordinated centrally which randomizes eligible patients to one of three treatment arms, and assigns patient numbers. Medication will be dispensed by the hospital pharmacies of the individual participating multidisciplinary pain centres, after proper labelling.
Intervention model description
A multicentre, randomized, open-label comparative trial evaluating topical treatment options (lidocaine 5% or capsaicine 8% patch) versus oral systemic treatment (pregabaline as standard of care) in adult patients suffering from localized neuropathic pain (LNP) syndromes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients eligible for inclusion in this study must fulfil all of the following criteria: * Subjects should be capable of giving their informed consent with sufficient knowledge of the Dutch, French or German language; * Males and females, 18 years and older; * Be assessed as suffering from moderate to severe neuropathic pain across the screening process with pain intensity (numeric rating scale - NRS) ≥ 4/10, * At the time of screening pain symptoms have to be present for at least one (1) month, with a maximum of 24 months; * Sensory disturbances present in the skin area of maximal pain; * At the time of screening pain is clearly related to the presence of a localized neuropathic pain syndrome. * Male or female patients of child producing potential\* must agree to use contraception or take measures to avoid pregnancy during the study and until after the final treatment; * Women can only be included after negative pregnancy test;
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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). |
| 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). |
Countries
Belgium
Outcome results
None listed