Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain

Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain; a Triple-Blind Randomized Crossover Controlled Trial

Participants with chronic, refractory phantom limb pain (PLP) or residual limb pain (RLP) for more than 6 months will be enrolled in this clinical trial. Aim: Define the attributable pain relief and functional improvement in participants with PLP/RLP after contralateral limb sciatic nerve block. Also, contribute to the basic science understanding of the crossed-withdraw reflex by demonstrating a known animal model phenomenon in human participants. Hypothesis: Contralateral limb sciatic nerve anesthetic block with 2% lidocaine provides immediate clinically meaningful pain reduction, defined as the proportion of patients with at least 50% improvement in NRS pain score in PLP/RLP when compared to sham.

Study Overview

• Status: Recruiting
• Conditions: Pain; Amputation
• Intervention / Treatment: Drug: 10 mL 2% lidocaine; Drug: 10 mL preservative free saline

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: David Walega, MD, MSCI; Phone Number: (312)926-8369; Email: d-walega@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Memorial Hospital
      • Contact: David Walega, M.D.; Phone Number: 312-695-2500; Email: d-walega@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Age greater than 18 years of age at day of enrollment
• 2. Lower extremity amputation performed more than 12 months before study enrollment
• 3. PLP/RLP in affected amputated limb > 4 on NRS26
• 4. 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)
• 5. Willingness to undergo image guided diagnostic nerve block

Exclusion Criteria:

• 1. Refusal / inability to participate or provide consent
• 2. Contraindications to diagnostic nerve block
• 3. Non-neurogenic source of PLP/RLP
• 4. Current opioid use > 50 morphine milligram equivalents per day
• 5. Any interventional pain treatment in the residual limb within the last 30 days
• 6. Severe uncontrolled medical condition (i.e., hypertensive crisis, decompensated hypothyroidism)
• 7. Use of investigational pain drug within past 30 days or other concurrent clinical trial enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group 2% lidocaine; Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.	Drug: 10 mL 2% lidocaine; Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
Placebo Comparator: Sham preservative free saline; Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.	Drug: 10 mL preservative free saline; Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the proportions of participants reporting ≥ 50% improvement in NRS pain score from baseline at 15 minutes in treatment and sham groups	Comparison of the proportions of participants reporting ≥ 50% improvement in NRS pain score on a scale of 0 (no pain) to 10 (worst pain imaginable) from baseline at 15 minutes in treatment and sham groups.	15 minutes after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean and standard deviation (SD) of change in NRS pain score at 1, 2, 3, 4, 5, 6, 24, 48, 72, 96, 120 hours post-saline and lidocaine injections	Mean and standard deviation (SD) of change in NRS pain score (0 no pain -10 worst pain imaginable) at 1, 2, 3, 4, 5, 6, 24, 48, 72, 96, 120 hours post-saline and lidocaine injections	120 hours
Mean and SD of average daily steps recorded at 24, 48, 72, 96, 120 hours post-saline and lidocaine injections (via Modus StepWatch™ or Evolution EvoWalk™)	Mean and SD of average daily steps recorded at 24, 48, 72, 96, 120 hours post-saline and lidocaine injections (via Modus StepWatch™ or Evolution EvoWalk™)	120 hours
Mean and SD of change in Orthotics and Prosthetics User's Survey (OPUS) score immediately post-injection and conclusion of washout (5 days) in saline and lidocaine groups	Mean and SD of change in Orthotics and Prosthetics User's Survey (OPUS) score ( 20 question survey scored on a 5 point range from very easy- to cannot perform this activity)immediately post-injection and conclusion of washout (5 days) in saline and lidocaine groups	5 days
Mean and SD of change in Groningen Activity Restriction Scale (GARS) score immediately post-injection and conclusion of washout (5 days) in saline and lidocaine groups	Mean and SD of change in Groningen Activity Restriction Scale (GARS) score (survey is 17 question survey scored 1= can do it fully to 4 =cannot do it all, a good score ranges from 17 to a poor score of 68 poor score) immediately post-injection and conclusion of washout (5 days) in saline and lidocaine groups	5 days
Demographic factors associated with large improvement in NRS pain score	NRS scored on a 11 point scale of 0= no pain to 10 worst pain imaginable.	5 days

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: David Walega, MD,MSCI, Northwestern University

Publications and helpful links

General Publications

• Richardson C, Glenn S, Horgan M, Nurmikko T. A prospective study of factors associated with the presence of phantom limb pain six months after major lower limb amputation in patients with peripheral vascular disease. J Pain. 2007 Oct;8(10):793-801. Epub 2007 Jul 12. Erratum in: J Pain. 2007 Dec;8(12):998.
• Cohen SP, Gilmore CA, Rauck RL, Lester DD, Trainer RJ, Phan T, Kapural L, North JM, Crosby ND, Boggs JW. Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Pain Following Amputation. Mil Med. 2019 Jul 1;184(7-8):e267-e274. doi: 10.1093/milmed/usz114.
• Ephraim PL, Wegener ST, MacKenzie EJ, Dillingham TR, Pezzin LE. Phantom pain, residual limb pain, and back pain in amputees: results of a national survey. Arch Phys Med Rehabil. 2005 Oct;86(10):1910-9. doi: 10.1016/j.apmr.2005.03.031.
• Hanley MA, Ehde DM, Jensen M, Czerniecki J, Smith DG, Robinson LR. Chronic pain associated with upper-limb loss. Am J Phys Med Rehabil. 2009 Sep;88(9):742-51; quiz 752, 779. doi: 10.1097/PHM.0b013e3181b306ec.
• Kooijman CM, Dijkstra PU, Geertzen JHB, Elzinga A, van der Schans CP. Phantom pain and phantom sensations in upper limb amputees: an epidemiological study. Pain. 2000 Jul;87(1):33-41. doi: 10.1016/S0304-3959(00)00264-5.
• Dijkstra PU, Geertzen JH, Stewart R, van der Schans CP. Phantom pain and risk factors: a multivariate analysis. J Pain Symptom Manage. 2002 Dec;24(6):578-85. doi: 10.1016/s0885-3924(02)00538-9.
• Yin Y, Zhang L, Xiao H, Wen CB, Dai YE, Yang G, Zuo YX, Liu J. The pre-amputation pain and the postoperative deafferentation are the risk factors of phantom limb pain: a clinical survey in a sample of Chinese population. BMC Anesthesiol. 2017 May 26;17(1):69. doi: 10.1186/s12871-017-0359-6.
• Desmond DM, Maclachlan M. Prevalence and characteristics of phantom limb pain and residual limb pain in the long term after upper limb amputation. Int J Rehabil Res. 2010 Sep;33(3):279-82. doi: 10.1097/MRR.0b013e328336388d.
• Schley MT, Wilms P, Toepfner S, Schaller HP, Schmelz M, Konrad CJ, Birbaumer N. Painful and nonpainful phantom and stump sensations in acute traumatic amputees. J Trauma. 2008 Oct;65(4):858-64. doi: 10.1097/TA.0b013e31812eed9e.
• Richardson C, Glenn S, Nurmikko T, Horgan M. Incidence of phantom phenomena including phantom limb pain 6 months after major lower limb amputation in patients with peripheral vascular disease. Clin J Pain. 2006 May;22(4):353-8. doi: 10.1097/01.ajp.0000177793.01415.bd.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 7, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): December 2, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Amputation; Phantom Pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: STU00215101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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