Osteoporotic Fracture and Lidocaine Plaster 5% for Neuropathic Pain preventioN

Sponsor
University Hospital, Clermont-Ferrand
Study ID
NCT07691359
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Neuropathic Pain
  • Osteoporotic Vertebral Fracture

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lidocaine 5% medicated plaster — DRUG
    A 5% lidocaine plaster applied once daily for 12 hours followed by 12 hours without the plaster for 2 months.

Study Details

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.

Key Dates

First listed
Jul 8, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Oct 1, 2027
Completion
Oct 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • No Intervention: Standard Care
    Participants receive standard care without a 5% lidocaine plaster.

Primary Outcome Measure

Development of neuropathic pain at 2 months [ Time Frame: Baseline - Day 0 and Visit 2 - Day 60 ]

Central Contacts

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