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Osteoporotic Fracture and Lidocaine Plaster 5% for Neuropathic Pain preventioN (FLYNN)

2 lipca 2026 zaktualizowane przez: University Hospital, Clermont-Ferrand

Preventive Effect of 5% Lidocaine Plaster on the Development of Neuropathic Pain Following Osteoporotic Vertebral Fracture: A Proof-of-concept, Controlled, Randomized 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Osteoporosis is associated with an increased risk of vertebral fractures that may result in persistent pain and impaired quality of life. Beyond nociceptive pain, a substantial proportion of patients develop neuropathic pain after osteoporotic vertebral fractures, which is associated with greater pain severity, sleep disturbances, and functional impairment. Current management often identifies neuropathic pain only after it has become chronic, while systemic treatments may increase the risk of adverse events in older adults.

The FLYNN study is a prospective, randomized, controlled, open-label, proof-of-concept Phase 2 clinical trial designed to evaluate whether early treatment with a 5% lidocaine plaster can prevent the development of neuropathic pain following an osteoporotic vertebral fracture. Participants aged 50 years or older with a vertebral osteoporotic fracture diagnosed within the previous month and pain intensity ≥3 on a numerical rating scale will be randomized in a 2:1 ratio to receive either daily treatment with a 5% lidocaine plaster (12 hours on/12 hours off) plus standard care or standard care alone for 2 months.

The primary endpoint is the occurrence of neuropathic pain 2 months after enrollment, defined by a PainDETECT score ≥19. Secondary outcomes include neuropathic pain assessed by DN4, pain intensity, treatment compliance, adverse events, concomitant medications, sleep quality (PSQI), health-related quality of life (SF-36), and psychophysical pain characterization in participants who develop neuropathic pain.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

30

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Francja
      • Clermont-Ferrand, Francja, 63000
        • CHU clermont-ferrand

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • 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.
  • Able and willing to provide written informed consent.
  • Affiliated with a French health insurance system.

Exclusion Criteria:

  • 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).
  • Pregnant or breastfeeding women.
  • Women of childbearing potential not using an effective contraceptive method.
  • Positive urine pregnancy test for women whose menopausal status cannot be confirmed.
  • Participation in another clinical research study.
  • Individuals under legal protection or deprived of liberty.
  • Refusal to participate.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 5% Lidocaine Plaster
Participants receive a 5% lidocaine plaster applied daily (12 hours on/12 hours off) for 2 months in addition to standard care.
Lek: Lidocaine 5% medicated plaster
A 5% lidocaine plaster applied once daily for 12 hours followed by 12 hours without the plaster for 2 months.
Brak interwencji: Standard Care
Participants receive standard care without a 5% lidocaine plaster.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Development of neuropathic pain at 2 months
Ramy czasowe: Baseline - Day 0 and Visit 2 - Day 60
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.
Baseline - Day 0 and Visit 2 - Day 60

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Pain assessment using the Neuropathic Pain Questionnaire (DN4)
Ramy czasowe: Baseline - Day 0 and Visit 2 - Day 60
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.
Baseline - Day 0 and Visit 2 - Day 60
Treatment compliance
Ramy czasowe: Day 1 to Day 60
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.
Day 1 to Day 60
Adverse events
Ramy czasowe: Day 1 to Day 60
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.
Day 1 to Day 60
Pain evaluation
Ramy czasowe: Baseline - Day 0, Day 1 to Day 60, and Visit 2 - Day 60
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
Baseline - Day 0, Day 1 to Day 60, and Visit 2 - Day 60
Concomitant medications
Ramy czasowe: Day 1 to Day 60
Concomitant medication use assessed using the participant daily diary. Participants record daily whether any concomitant medication was taken (Yes/No). When applicable, the medication name and dosage are documented.
Day 1 to Day 60
The 36-Item Short Form Survey (SF-36)
Ramy czasowe: Baseline - Day 0 and Visit 2 - Day 60
The quality of life of patients is assessed by the general questionnaire 36-Item Short Form Survey (SF-36) which can be administered by self or hetero-questionnaire. The SF-36 questionnaire was developed from the Medical Outcome Study, a 149-item questionnaire that was developed to assess how the American healthcare system affects the outcome of care. The SF-36 questionnaire is composed of 36 items and makes it possible to assess the physical and mental health of an individual using eleven questions relating to eight aspects of health: Physical activity, limitations due to physical state, physical pain, perceived health, vitality, life and relationship with others, limitations due to the mental state and mental health. Scores between 0 and 100 are determined. Scores tending towards 100 indicate a better quality of life.
Baseline - Day 0 and Visit 2 - Day 60
The Pittsburgh Sleep Quality Index (PSQI)
Ramy czasowe: Baseline - Day 0 and Visit 2 - Day 60
The PSQI is a self-administered questionnaire with 19 items. It was developed to measure sleep quality in the month prior to the patient interview. This questionnaire includes 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, hypnotic medication use and daytime dysfunction. The global score (0 to 21) is obtained by adding the sub-scores of the 7 components, each ranging from 0 to 3 points. In the absence of an answer to one or more questions, the subtotal using this question cannot be calculated and will affect the overall score. The higher the overall score, the greater the impairment in sleep quality. An overall score >5 is an indicator of sleep disturbance.
Baseline - Day 0 and Visit 2 - Day 60
Measurement of the threshold of sensitivity and pain perception induced by a thermal stimulus (hot and cold) at the Pathway - Médoc®
Ramy czasowe: Visit 2 - Day 60
The measurements will be performed using an ATS thermode applied to the dominant arm of the patients. The Pathway-Medoc system associated with the thermode allows, from a base value of 32°C, to deliver adjustable temperature peaks (in the hot or in the cold and according to a regular slope of 1°C) and controlled by fast feedback, which allows to adapt to the different sensitivity thresholds of the C and A fibers. This device will be used to evaluate: the sensitivity threshold to heat, the sensitivity threshold to cold, the pain threshold to heat and the pain threshold to cold. The determination of each threshold will be established by an average of three measurements.
Visit 2 - Day 60
Central sensitization tests, measurement of the Conditioned Pain Modulation (CPM) effect
Ramy czasowe: Visit 2 - Day 60
The patients are seated, the ATS thermode associated with the Pathway is applied to the dominant forearm. From the baseline value of 32°C, the Pathway delivers a "Pain 60 / Test stimulus" for 10 seconds, and the patient scores the pain on a visual numerical scale from 0 to 100. Then, the Pathway delivers a "Pain 60 / Test stimulus" for 30 seconds, and the patient scores the pain on the same scale. Fifteen minutes after the end of the two stimulations, the patient immersed the non-dominant arm for 60 seconds in a water bath at 46.5°C. Then a second identical sequence of 10 and 30 second stimulations was performed, with the scores recorded after each stimulation on the visual numerical scale from 0 to 100. The CPM effect is measured by taking the difference between the pain scores on the visual numerical scale before and after immersion.
Visit 2 - Day 60

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University Hospital, Clermont-Ferrand

Śledczy

  • Główny śledczy: Marie-Eva PICKERING, University Hospital, Clermont-Ferrand

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 października 2027

Ukończenie studiów (Szacowany)

1 października 2028

Daty rejestracji na studia

Pierwszy przesłany

2 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 lipca 2026

Pierwszy wysłany (Rzeczywisty)

8 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

8 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 lipca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • RBHP 2025 PICKERING-ME 4
  • 2025-524889-25-00 (Ctis)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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