Osteoporotic Fracture and Lidocaine Plaster 5% for Neuropathic Pain preventioN

NCT07691359 | Not Yet Recruiting Phase 4

• 2 other identifiers: RBHP 2025 PICKERING-ME 42025-524889-25-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuropathic Pain; Osteoporotic Vertebral Fracture

Keywords

Lidocaine 5% Plaster; Lidocaine Patch; Osteoporosis; Pain Prevention; PainDETECT; DN4

Outcome Measures

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.

  Baseline - Day 0 and Visit 2 - Day 60

Secondary Outcomes (9)

• Pain assessment using the Neuropathic Pain Questionnaire (DN4)

  Baseline - Day 0 and Visit 2 - Day 60

• Treatment compliance

  Day 1 to Day 60

• Adverse events

  Day 1 to Day 60

• Pain evaluation

  Baseline - Day 0, Day 1 to Day 60, and Visit 2 - Day 60

• Concomitant medications

  Day 1 to Day 60

Study Arms (2)

5% Lidocaine Plaster

EXPERIMENTAL

Participants receive a 5% lidocaine plaster applied daily (12 hours on/12 hours off) for 2 months in addition to standard care.

Drug: Lidocaine 5% medicated plaster

Standard Care

NO INTERVENTION

Participants receive standard care without a 5% lidocaine plaster.

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.

5% Lidocaine Plaster

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Neuralgia; Osteoporosis

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Marie-Eva PICKERING

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

0473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 2:1 ratio to receive either a 5% lidocaine plaster plus standard care or standard care alone for 2 months. Randomization will be stratified by sex using randomly sized blocks.

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-06

Locations

FR (1)