Impact of 5% Lidocaine Medicated Plaster on Allodynic Symptoms of Localized Neuropathic Pain After Knee Surgery
- Conditions
- Allodynic SymptomsLocalized Neuropathic Pain
- Interventions
- Other: placebo plaster
- Registration Number
- NCT02763592
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief Summary
The aim of this study is to evaluate the impact of 5% lidocaine medicated plaster on allodynic symptoms of localized neuropathic pain after knee surgery.
- Detailed Description
This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial comparing 5% lidocaine medicated plaster (5LP) and placebo whether neuropathic pain symptoms (dynamic mechanical allodynia, pressure, hot and cold) have a different chronological improvement with 5LP compared to placebo. Pain intensity and pain relief, sleep and quality of life and osteoarthritis severity are also assessed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- Aged from 18 to 80 years
- Male or female, for women of childbearing potential, a negative pregnancy test
- Patients with PONP following knee surgery
- Patients with neuropathic pain DN4 ≥ 4
- Patients at least 3 months post-surgery
- Patients suffering from at least the allodynic brush-induced mechanical allodynia symptom (DMA) rated as ≥ 5/10 on the numerical scale
- Patient with no localized neuropathic pain symptoms (DN4<4) on the contralateral knee
- Intact skin besides the scar of surgery (absence of skin disease, skin irritation, inflammation or injury, such as active herpes zoster lesions, atopic dermatitis, wounds) in the area where the medicated plasters will be applied
- Naive from Versatis® treatment
- Treated with stable systemic analgesic and planned to remain stable all over the duration of the study
- Insured by French social security
- Included or agreement to be included in the national register of participants in biomedical research
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo plaster This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial comparing 5% lidocaine medicated plaster (5LP) and placebo whether neuropathic pain symptoms (dynamic mechanical allodynia, pressure, hot and cold) have a different chronological improvement with 5LP compared to placebo Lidocaine Lidocaine This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial comparing 5% lidocaine medicated plaster (5LP) and placebo whether neuropathic pain symptoms (dynamic mechanical allodynia, pressure, hot and cold) have a different chronological improvement with 5LP compared to placebo
- Primary Outcome Measures
Name Time Method Time to response to treatment from inclusion to 3 months Time to response to treatment defined as a 30% reduction in dynamic brush-induced mechanical allodynia on the localized pain area during the chronological period extending from inclusion to 3 months
- Secondary Outcome Measures
Name Time Method - Kinetics of evolution over time of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) in both groups (Placebo and 5LP) at inclusion - Kinetics of evolution over time of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) in both groups (Placebo and 5LP)
Pain evaluated with numerical rating scale ranging from 0 to 10 at inclusion Pain evaluated with numerical rating scale ranging from 0 to 10
- Kinetics of evolution over time of pain evaluated by numeric scale ranging from 0 to 10 with Mechanical Detection Threshold (MDT) in both groups (Placebo and 5LP) at inclusion - Kinetics of evolution over time of pain evaluated by numeric scale ranging from 0 to 10 with Mechanical Detection Threshold (MDT) in both groups (Placebo and 5LP)
Pathophysiology of neuropathic characteristics with DN4 questionnaire at inclusion Pathophysiology of neuropathic characteristics with DN4 questionnaire
Evolution of the size of the allodynic area at inclusion - Responder rate, defined as 30% and 50% reduction over time on pain evaluated by numeric scale ranging from 0 to 10 with brush-induced Dynamic Mechanical Allodynia (DMA) at 3 months - Responder rate, defined as 30% and 50% reduction over time on pain evaluated by numeric scale ranging from 0 to 10 with brush-induced Dynamic Mechanical Allodynia (DMA)
- Responder rate, defined as 30% and 50% reduction over time on pain evaluated by numeric scale ranging from 0 to 10 with Mechanical Detection Threshold (MDT) at 3 months - Responder rate, defined as 30% and 50% reduction over time on pain evaluated by numeric scale ranging from 0 to 10 with Mechanical Detection Threshold (MDT)
- Kinetics of evolution over time of pain evaluated by numeric scale ranging from 0 to 10 with brush-induced Dynamic Mechanical Allodynia (DMA) in both groups (Placebo and 5LP) from inclusion to 3 months Kinetics of evolution over time of pain evaluated by numeric scale ranging from 0 to 10 with brush-induced Dynamic Mechanical Allodynia (DMA) in both groups (Placebo and 5LP)
- Responder rate, defined as 30% and 50% reduction over time on Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) at 3 months - Responder rate, defined as 30% and 50% reduction over time on Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT)
- Comparison of pain evaluated by numeric scale ranging from 0 to 10 with brush-induced Dynamic Mechanical Allodynia (DMA) between painful knee and contralateral knee on the same anatomic location. at 3 months - Comparison of pain evaluated by numeric scale ranging from 0 to 10 with brush-induced Dynamic Mechanical Allodynia (DMA) between painful knee and contralateral knee on the same anatomic location.
- Comparison of pain evaluated by numeric scale ranging from 0 to 10 with Mechanical Detection Threshold (MDT) between painful knee and contralateral knee on the same anatomic location at 3 months - Comparison of pain evaluated by numeric scale ranging from 0 to 10 with Mechanical Detection Threshold (MDT) between painful knee and contralateral knee on the same anatomic location
- Comparison of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) between painful knee and contralateral knee on the same anatomic location. at 3 months - Comparison of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) between painful knee and contralateral knee on the same anatomic location.
Evolution of sleep by Pittsburgh Sleep Quality Index (PGIC) questionnaire. at 3 months Evolution of sleep by Pittsburgh Sleep Quality Index (PGIC) questionnaire.
Evolution of quality of life by Short-Form 12 (SF-12) questionnaire. at 3 months Evolution of quality of life by Short-Form 12 (SF-12) questionnaire.
Evolution of Patient Global Impression of Change (PGIC) questionnaire at 3 months Evolution of Patient Global Impression of Change (PGIC) questionnaire
Trial Locations
- Locations (1)
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France