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Trial record 13 of 119 for:    "Neuromuscular Disease" | "Lidocaine"

Impact of 5% Lidocaine Medicated Plaster on Allodynic Symptoms of Localized Neuropathic Pain After Knee Surgery (LiNe)

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ClinicalTrials.gov Identifier: NCT02763592
Recruitment Status : Completed
First Posted : May 5, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Allodynic Symptoms Localized Neuropathic Pain Drug: Lidocaine Other: placebo plaster Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Impact of 5% Lidocaine Medicated Plaster on Allodynic Symptoms of Localized Neuropathic Pain After Knee Surgery
Actual Study Start Date : May 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Lidocaine
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

Placebo Comparator: placebo
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
Other: 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. Pain intensity and pain relief, sleep and quality of life and osteoarthritis severity are also assessed.




Primary Outcome Measures :
  1. Time to response to treatment [ Time Frame: 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 :
  1. - 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) [ Time Frame: 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)

  2. - 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) [ Time Frame: 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)

  3. - Kinetics of evolution over time of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) in both groups (Placebo and 5LP) [ Time Frame: at inclusion ]
    - Kinetics of evolution over time of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) in both groups (Placebo and 5LP)

  4. Pain evaluated with numerical rating scale ranging from 0 to 10 [ Time Frame: at inclusion ]
    Pain evaluated with numerical rating scale ranging from 0 to 10

  5. Pathophysiology of neuropathic characteristics with DN4 questionnaire [ Time Frame: at inclusion ]
    Pathophysiology of neuropathic characteristics with DN4 questionnaire

  6. Evolution of the size of the allodynic area [ Time Frame: at inclusion ]
  7. - 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) [ Time Frame: 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)

  8. - 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) [ Time Frame: 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)

  9. - Responder rate, defined as 30% and 50% reduction over time on Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) [ Time Frame: at 3 months ]
    - Responder rate, defined as 30% and 50% reduction over time on Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT)

  10. - 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. [ Time Frame: 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.

  11. - 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 [ Time Frame: 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

  12. - Comparison of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) between painful knee and contralateral knee on the same anatomic location. [ Time Frame: 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.

  13. Evolution of sleep by Pittsburgh Sleep Quality Index (PGIC) questionnaire. [ Time Frame: at 3 months ]
    Evolution of sleep by Pittsburgh Sleep Quality Index (PGIC) questionnaire.

  14. Evolution of quality of life by Short-Form 12 (SF-12) questionnaire. [ Time Frame: at 3 months ]
    Evolution of quality of life by Short-Form 12 (SF-12) questionnaire.

  15. Evolution of Patient Global Impression of Change (PGIC) questionnaire [ Time Frame: at 3 months ]
    Evolution of Patient Global Impression of Change (PGIC) questionnaire



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763592


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02763592     History of Changes
Other Study ID Numbers: CHU-0261
RBHP 2015 PICKERING 4 ( Other Identifier: CHU Clermont-Ferrand )
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Keywords provided by University Hospital, Clermont-Ferrand:
Localized Neuropathic pain
5% lidocaine medicated plaster
Knee surgery
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Neuralgia
Peripheral Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action