Impact of Peripheral Afferent Input on Central Neuropathic Pain

NCT05646810 | Unknown

• 1 other identifier: 39451
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injuries; Spinal Cord Diseases; Syringomyelia

Keywords

central pain; peripheral afferent input; neuropathic pain; spinal cord injury

Outcome Measures

Primary Outcomes (1)

• Indication of most pain relief

  Limb with most pain relief on Numerical Rating Scale (NRS) \[0-10, 0=no pain 10=worst pain imaginable\] 40 minutes after nerve block

  40 minutes

Secondary Outcomes (6)

• Intensity on Numerical Rating Scale (NRS) [0-10, 0=no pain 10=worst pain imaginable] of spontaneous pain

  90 minutes

• Pain relief 45 min after the nerve block

  45 minutes

• Pain extent [% of body surface on standardized pain drawings] 50 minutes after the nerve block

  50 minutes

• Pain descriptors 50 minutes after the nerve block

  50 minutes

• Area [% of pain extent] of hypersensitivity to thermal and nociceptive stimuli

  95 minutes

Other Outcomes (1)

• Plasma lidocaine concentrations

  40 minutes

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Nerve block

Diagnostic Test: Lidocaine (10 mg/ml)

Isotonic saline

PLACEBO COMPARATOR

Nerve block

Diagnostic Test: Isotonic saline

Interventions

Lidocaine (10 mg/ml) DIAGNOSTIC_TEST

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

Lidocaine

Isotonic saline DIAGNOSTIC_TEST

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

Isotonic saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases; Syringomyelia; Neuralgia

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Rosner, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nanna B. Finnerup, Professor

CONTACT

0045 784 63380; finnerup@clin.au.dk

Jan Rosner, MD

CONTACT

0041 79 952 4551; jan.rosner@balgrist.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 12, 2022
• Study Start: December 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: December 12, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share