Osteoporotic Fracture and Lidocaine Plaster 5% for Neuropathic Pain preventioN
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
Osteoporotic vertebral fractures may lead to chronic pain with a neuropathic component, which is often underdiagnosed and undertreated in older adults. This proof-of-concept randomized controlled trial aims to evaluate whether early application of a 5% lidocaine plaster can prevent the development of neuropathic pain following an osteoporotic vertebral fracture. Participants will be randomized in a 2:1 ratio to receive either a daily 5% lidocaine plaster plus standard care or standard care alone for 2 months. The primary outcome is the proportion of participants who develop neuropathic pain at 2 months, assessed using the PainDETECT questionnaire.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participant aged 50 years or older.
Diagnosis of osteoporosis established by the treating rheumatologist.
Osteoporotic vertebral fracture diagnosed within the previous month.
Pain intensity of ≥3 on a numerical rating scale at the fracture site.
Disqualifiers
Medical or surgical condition considered by the investigator to be incompatible with study participation.
Known hypersensitivity to lidocaine, any excipient of the study treatment, or other amide-type local anesthetics.
Current treatment with Class I antiarrhythmic agents (e.g., tocainide, mexiletine) or other local anesthetics.
Inflamed or damaged skin at the intended application site (e.g., active herpes zoster lesions, dermatitis, or wounds).
Trial design
Design model
Parallel
Treatments tested in this trial
Lidocaine 5% medicated plaster
DrugA 5% lidocaine plaster applied once daily for 12 hours followed by 12 hours without the plaster for 2 months.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: 5% Lidocaine PlasterExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Development of neuropathic pain at 2 months
Percentage of participants who develop neuropathic pain 2 months after enrollment, assessed using the PainDETECT questionnaire. This self-administered questionnaire evaluates pain quality, temporal pattern, and radiation to estimate the likelihood of neuropathic pain. The total score allows classification of pain as unlikely, possible, or likely neuropathic. Neuropathic pain is defined as a PainDETECT score ≥19.
Time frame
Baseline - Day 0 and Visit 2 - Day 60Secondary outcomes
1
Pain assessment using the Neuropathic Pain Questionnaire (DN4)
Neuropathic Pain (DN4): This questionnaire estimates the probability of neuropathic pain in a patient, by means of four questions divided into ten items to be ticked. The practitioner or clinical research associate in charge of the study interviews or examines the patient and fills in the questionnaire himself. Each item is marked with a "yes" or "no" answer. Each "yes" is worth a score of 1, and each "no" is worth a score of 0. The sum of the scores gives the patient's score (out of 10); if the patient's score is equal to or greater than 4/10, the test is positive.
Time frame
Baseline - Day 0 and Visit 2 - Day 602
Treatment compliance
Treatment compliance in the intervention group, assessed by daily documentation of 5% lidocaine plaster application (Yes/No) in the participant daily diary throughout the 2-month treatment period.
Time frame
Day 1 to Day 603
Adverse events
Incidence of adverse events, assessed using the participant daily diary. Participants record the occurrence of adverse events daily (Yes/No) and provide additional details when an adverse event is reported.
Time frame
Day 1 to Day 604
Pain evaluation
Pain evaluation assessed using an 11-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain). Pain is recorded at baseline, daily in the participant diary throughout the treatment period, and at the end-of-study visit
Time frame
Baseline - Day 0, Day 1 to Day 60, and Visit 2 - Day 60Sponsors and contacts
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Source ClinicalTrials.gov
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