Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine Group | Experimental | Subjects will receive a lidocaine injection in the back of their residual limb. |
|
| Sham Group | Placebo Comparator | Subjects will receive a placebo injection in the back of their residual limb. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | 2 teaspoons of 2% lidocaine injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain | Measured using self-reported Numerical Rating Scale (NRS) where 0=no pain and 10=worst pain. | Baseline, 60 minutes post injection |
| 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. | Baseline, 5 days post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 5 days post-injection |
| Change in Pressure-Pain Algometry |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cole Cheney, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Health System - Mankato | Recruiting | Mankato | Minnesota | 56001 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Saline injection |
|
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). |
| Baseline, 5 days post-injection |
| Step Count | Number of daily steps recorded by Modus StepWatch™ or Evolution EvoWalk™ fitted to the participant's prostheses | 5 days post-injection |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010146 | Pain |
| Aniline Compounds |
| D000588 | Amines |