A Study of Contralateral Limb Block
ConditionLimb Pain, Phantom
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lidocaine
Drug2 teaspoons of 2% lidocaine injection
Placebo
DrugSaline injection
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Lidocaine GroupExperimental treatment 1 intervention
Group B: Sham GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in pain
Measured using self-reported Numerical Rating Scale (NRS) where 0=no pain and 10=worst pain.
Time frame
Baseline, 60 minutes post injection2
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.
Time frame
Baseline, 5 days post-injectionSecondary outcomes
1
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.
Time frame
Baseline, 5 days post-injection2
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).
Time frame
Baseline, 5 days post-injection3
Step Count
Number of daily steps recorded by Modus StepWatch™ or Evolution EvoWalk™ fitted to the participant's prostheses
Time frame
5 days post-injectionSponsors and contacts
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Source ClinicalTrials.gov