Back to resultsA Study of Contralateral Limb Block
Primary Purpose
Limb Pain, Phantom
Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Limb Pain, Phantom
Eligibility Criteria
Inclusion Criteria: Lower extremity amputation performed more than 12 months before study enrollment PLP/RLP in affected amputated limb > 4 on NRS26 Pain duration of more than 6 months despite a trial of conservative therapies for at least 2 months, including oral medications, topical medicines, physical therapy, and physical modalities (i.e., heat, cold, transcutaneous electrical nerve stimulation, phonophoresis) Willingness to undergo image guided diagnostic nerve block Exclusion Criteria: Refusal / inability to participate or provide consent Contraindications to diagnostic nerve block Non-neurogenic source of PLP/RLP Current opioid use > 50 morphine milligram equivalents per day Any interventional pain treatment in the residual limb within the last 30 days Severe uncontrolled medical condition (i.e., hypertensive crisis, decompensated hypothyroidism) Use of investigational pain drug within past 30 days or other concurrent clinical trial enrollment
Sites / Locations
- Mayo Clinic Health System - Mankato
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lidocaine Group
Sham Group
Arm Description
Subjects will receive a lidocaine injection in the back of their residual limb.
Subjects will receive a placebo injection in the back of their residual limb.
Outcomes
Primary Outcome Measures
Change in pain
Measured using self-reported Numerical Rating Scale (NRS) where 0=no pain and 10=worst pain.
Change in Functional Improvement
Measured using self-reported 20-item Orthotic and Prosthetics User's Survey (OPUS) Lower Extremity Functional Status Measurement survey. Total scores range from 0-100 scale with higher scores indicating a better outcome.
Secondary Outcome Measures
Change in disability
Measured using self-reported 18-item The Groningen Activity Restriction Scale (GARS) that is a general disease independent instrument for measuring disability. Total scores range from 18-72. The higher the score the greater the disability.
Change in Pressure-Pain Algometry
Qualified study personnel will measure pain pressure threshold three times at each visit with an algometer on the participant's residual limb at the point of a maximal pain as indicated by the participant during pre-block physical examination, reported in kilopascal (kPa).
Step Count
Number of daily steps recorded by Modus StepWatch™ or Evolution EvoWalk™ fitted to the participant's prostheses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06045936
Brief Title
A Study of Contralateral Limb Block
Official Title
Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain; a Double-Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research is being done to determine if an anesthetic like Lidocaine, may be effective when injected around the sciatic nerve of the intact limb in patients with limb loss pain on the contralateral side.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limb Pain, Phantom
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine Group
Arm Type
Experimental
Arm Description
Subjects will receive a lidocaine injection in the back of their residual limb.
Arm Title
Sham Group
Arm Type
Placebo Comparator
Arm Description
Subjects will receive a placebo injection in the back of their residual limb.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
2 teaspoons of 2% lidocaine injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline injection
Primary Outcome Measure Information:
Title
Change in pain
Description
Measured using self-reported Numerical Rating Scale (NRS) where 0=no pain and 10=worst pain.
Time Frame
Baseline, 60 minutes post injection
Title
Change in Functional Improvement
Description
Measured using self-reported 20-item Orthotic and Prosthetics User's Survey (OPUS) Lower Extremity Functional Status Measurement survey. Total scores range from 0-100 scale with higher scores indicating a better outcome.
Time Frame
Baseline, 5 days post-injection
Secondary Outcome Measure Information:
Title
Change in disability
Description
Measured using self-reported 18-item The Groningen Activity Restriction Scale (GARS) that is a general disease independent instrument for measuring disability. Total scores range from 18-72. The higher the score the greater the disability.
Time Frame
Baseline, 5 days post-injection
Title
Change in Pressure-Pain Algometry
Description
Qualified study personnel will measure pain pressure threshold three times at each visit with an algometer on the participant's residual limb at the point of a maximal pain as indicated by the participant during pre-block physical examination, reported in kilopascal (kPa).
Time Frame
Baseline, 5 days post-injection
Title
Step Count
Description
Number of daily steps recorded by Modus StepWatch™ or Evolution EvoWalk™ fitted to the participant's prostheses
Time Frame
5 days post-injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Lower extremity amputation performed more than 12 months before study enrollment
PLP/RLP in affected amputated limb > 4 on NRS26
Pain duration of more than 6 months despite a trial of conservative therapies for at least 2 months, including oral medications, topical medicines, physical therapy, and physical modalities (i.e., heat, cold, transcutaneous electrical nerve stimulation, phonophoresis)
Willingness to undergo image guided diagnostic nerve block
Exclusion Criteria:
Refusal / inability to participate or provide consent
Contraindications to diagnostic nerve block
Non-neurogenic source of PLP/RLP
Current opioid use > 50 morphine milligram equivalents per day
Any interventional pain treatment in the residual limb within the last 30 days
Severe uncontrolled medical condition (i.e., hypertensive crisis, decompensated hypothyroidism)
Use of investigational pain drug within past 30 days or other concurrent clinical trial enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cole Cheney, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Health System - Mankato
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56001
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cole Cheney, MD
Phone
515-681-6338
Email
cheney.cole@mayo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Contralateral Limb Block
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