Impact of Peripheral Afferent Input on Central Neuropathic Pain

NCT ID: NCT05646810

Last Updated: 2022-12-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-12-31

Brief Summary

The overarching aim of this study is to investigate the contribution of peripheral afferent input to spontaneous and evoked central neuropathic pain after a spinal cord lesion or disease.

Detailed Description

A key question that has been subject to longstanding debates in the field relates to the sites and mechanisms within the peripheral or central nervous system that potentially perpetuate chronic spontaneous and evoked central neuropathic pain. The investigators hypothesize that spontaneous central neuropathic pain depends on continuous, "physiological" somatosensory input from the painful body region in the periphery. Thus, spontaneous central neuropathic pain results from pathological gain control in central somatosensory networks with decreased activation thresholds for thermo- and mechanosensitive peripheral afferents.

Conditions

Spinal Cord Injuries; Spinal Cord Diseases; Syringomyelia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine

Nerve block

Group Type: ACTIVE_COMPARATOR

Lidocaine (10 mg/ml)

Intervention Type: DIAGNOSTIC_TEST

Lidocaine (10 mg/ml) will be injected according to established protocols using ultrasound guidance and an aseptic technique by an experienced anesthesiologist.

Isotonic saline

Nerve block

Group Type: PLACEBO_COMPARATOR

Isotonic saline

Intervention Type: DIAGNOSTIC_TEST

Isotonic saline will be injected according to established protocols using ultrasound guidance and an aseptic technique by an experienced anesthesiologist.

Interventions

Lidocaine (10 mg/ml)

Lidocaine (10 mg/ml) will be injected according to established protocols using ultrasound guidance and an aseptic technique by an experienced anesthesiologist.

Intervention Type: DIAGNOSTIC_TEST

Isotonic saline

Isotonic saline will be injected according to established protocols using ultrasound guidance and an aseptic technique by an experienced anesthesiologist.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Definite central neuropathic pain according to current diagnostic algorithms involving at least both feet or both hands bilaterally and symmetrically with regard to the expected neuroanatomical distribution of the nerve block.
• Patients with spinal cord injury. For patients with pain in both legs, the injury has to be incomplete. For patients with pain in both arms, the injury can be complete or incomplete. The pain in the area that will be investigated (region of interest) has to be in an area with at least some preservation of sensation
• An intensity of spontaneous pain of ≥4 NRS [0-10] in the region of interest during the screening visit and at the day of the intervention.
• Participant is able and willing to give informed consent.
• For female subjects of childbearing potential: A negative pregnancy test and either use of highly effective contraception or sexual abstinence

Exclusion Criteria

• Conus/cauda involvement or evidence of peripheral neuropathic pain due to documented peripheral lesion.
• Other known neurological and psychiatric conditions
• History or symptoms of significant diseases that may confound the measurements or represent contra-indications for the intervention (e.g., neuropathy following cancer or metabolic diseases such as diabetes mellitus, liver diseases, and kidney diseases.
• Cardiovascular diseases that preclude the anaesthetic intervention (e.g., arrythmias).
• Concomitant nociceptive pain within the innervation territory of the planned nerve block.
• Unable to understand and speak Danish
• Changes in pain medication within the last 4 weeks prior to the intervention.
• Treatment with warfarin or other blood thinning medications, that contraindicates regional anesthesia if the treating physician cannot recommend that such treatments are paused for at least 7 days before the study day
• Infection or skin disease in planned injection area
• Allergy for local anesthetics
• Pregnancy or lactation.
• Alcohol or drug abuse
• Pain intensity below 4 in the region of interest at the baseline measurement before the nerve block

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Rosner, MD

Role: PRINCIPAL_INVESTIGATOR

Danish Pain Research Center, Department of Clinical Medicine, Aarhus University

Central Contacts

Nanna B. Finnerup, Professor

Role: CONTACT

finnerup@clin.au.dk

0045 784 63380

Jan Rosner, MD

Role: CONTACT

jan.rosner@balgrist.ch

0041 79 952 4551

Other Identifiers

39451

Identifier Type: -

Identifier Source: org_study_id