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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

Tracking Information
First Submitted Date  ICMJE April 11, 2016
First Posted Date  ICMJE May 5, 2016
Last Update Posted Date April 4, 2017
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02763592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
  • - 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)
  • - 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)
  • - 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)
  • 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
  • Pathophysiology of neuropathic characteristics with DN4 questionnaire [ Time Frame: at inclusion ]
    Pathophysiology of neuropathic characteristics with DN4 questionnaire
  • Evolution of the size of the allodynic area [ Time Frame: 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) [ 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)
  • - 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)
  • - 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)
  • - 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.
  • - 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
  • - 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.
  • 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.
  • 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.
  • Evolution of Patient Global Impression of Change (PGIC) questionnaire [ Time Frame: at 3 months ]
    Evolution of Patient Global Impression of Change (PGIC) questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of 5% Lidocaine Medicated Plaster on Allodynic Symptoms of Localized Neuropathic Pain After Knee Surgery
Official Title  ICMJE Impact of 5% Lidocaine Medicated Plaster on Allodynic Symptoms of Localized Neuropathic Pain After Knee Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Allodynic Symptoms
  • Localized Neuropathic Pain
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Drug: Lidocaine
  • 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
    Intervention: Other: placebo plaster
Publications * Pickering G, Voute M, Macian N, Ganry H, Pereira B. Effectiveness and safety of 5% lidocaine-medicated plaster on localized neuropathic pain after knee surgery: a randomized, double-blind controlled trial. Pain. 2019 May;160(5):1186-1195. doi: 10.1097/j.pain.0000000000001502.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2017)
37
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2016)
36
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02763592
Other Study ID Numbers  ICMJE CHU-0261
RBHP 2015 PICKERING 4 ( Other Identifier: CHU Clermont-Ferrand )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP