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

Primary Purpose

Allodynic Symptoms, Localized Neuropathic Pain

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Lidocaine
placebo plaster
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allodynic Symptoms focused on measuring Localized Neuropathic pain, 5% lidocaine medicated plaster, Knee surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine

placebo

Arm 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

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

Outcomes

Primary Outcome Measures

Time to response to treatment
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

- 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 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)
- 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)
- 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
Pain evaluated with numerical rating scale ranging from 0 to 10
Pathophysiology of neuropathic characteristics with DN4 questionnaire
Pathophysiology of neuropathic characteristics with DN4 questionnaire
Evolution of the size of the allodynic area
- 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 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)
- 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)
- 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.
- 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
- 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.
- 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.
Evolution of sleep by Pittsburgh Sleep Quality Index (PGIC) questionnaire.
Evolution of quality of life by Short-Form 12 (SF-12) questionnaire.
Evolution of quality of life by Short-Form 12 (SF-12) questionnaire.
Evolution of Patient Global Impression of Change (PGIC) questionnaire
Evolution of Patient Global Impression of Change (PGIC) questionnaire

Full Information

First Posted
April 11, 2016
Last Updated
March 31, 2017
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT02763592
Brief Title
Impact of 5% Lidocaine Medicated Plaster on Allodynic Symptoms of Localized Neuropathic Pain After Knee Surgery
Acronym
LiNe
Official Title
Impact of 5% Lidocaine Medicated Plaster on Allodynic Symptoms of Localized Neuropathic Pain After Knee Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allodynic Symptoms, Localized Neuropathic Pain
Keywords
Localized Neuropathic pain, 5% lidocaine medicated plaster, Knee surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Experimental
Arm 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
Arm Title
placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
placebo plaster
Intervention 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.
Primary Outcome Measure Information:
Title
Time to response to treatment
Description
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
Time Frame
from inclusion to 3 months
Secondary Outcome Measure Information:
Title
- 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)
Description
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
Title
- 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)
Description
- 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
Title
- Kinetics of evolution over time of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) in both groups (Placebo and 5LP)
Description
- 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
Title
Pain evaluated with numerical rating scale ranging from 0 to 10
Description
Pain evaluated with numerical rating scale ranging from 0 to 10
Time Frame
at inclusion
Title
Pathophysiology of neuropathic characteristics with DN4 questionnaire
Description
Pathophysiology of neuropathic characteristics with DN4 questionnaire
Time Frame
at inclusion
Title
Evolution of the size of the allodynic area
Time Frame
at inclusion
Title
- 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)
Description
- 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
Title
- 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)
Description
- 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
Title
- Responder rate, defined as 30% and 50% reduction over time on Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT)
Description
- 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
Title
- 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.
Description
- 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
Title
- 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
Description
- 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
Title
- Comparison of Cold Detection Threshold (CDT) and Warm Detection Threshold (WDT) between painful knee and contralateral knee on the same anatomic location.
Description
- 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
Title
Evolution of sleep by Pittsburgh Sleep Quality Index (PGIC) questionnaire.
Description
Evolution of sleep by Pittsburgh Sleep Quality Index (PGIC) questionnaire.
Time Frame
at 3 months
Title
Evolution of quality of life by Short-Form 12 (SF-12) questionnaire.
Description
Evolution of quality of life by Short-Form 12 (SF-12) questionnaire.
Time Frame
at 3 months
Title
Evolution of Patient Global Impression of Change (PGIC) questionnaire
Description
Evolution of Patient Global Impression of Change (PGIC) questionnaire
Time Frame
at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisèle PICKERING
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31009419
Citation
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.
Results Reference
derived

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

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