Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05046639
• Other study ID #: STU00215101
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2021
• Est. completion date: March 2024

Study information

• Verified date: February 2023
• Source: Northwestern University
• Contact: David Walega, MD, MSCI
• Phone: (312)926-8369
• Email: d-walega[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Pain

Intervention

Drug:
• 10 mL 2% lidocaine
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
• 10 mL preservative free saline
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1016/j.jpain.2007.05.007. Epub 2007 Jul 12. Erratum In: J Pain. 2007 Dec;8(12):998. — View Citation

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.0000177 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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