Impact of Peripheral Afferent Input on Central Neuropathic Pain

Spinal Cord Injuries Clinical Trial

Official title:

Impact of Peripheral Afferent Input on Central Neuropathic Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05646810
• Other study ID #: 39451
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: University of Aarhus
• Contact: Nanna B. Finnerup, Professor
• Phone: 0045 784 63380
• Email: finnerup[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Spinal Cord Diseases
• Spinal Cord Injuries
• Syringomyelia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma lidocaine concentrations	Plasma lidocaine concentrations approx. 40 min after the block.	40 minutes
Primary	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	Intensity on Numerical Rating Scale (NRS) [0-10, 0=no pain 10=worst pain imaginable] of spontaneous pain	Intensity on Numerical Rating Scale (NRS) [0-10, 0=no pain 10=worst pain imaginable] of spontaneous pain in the pre-specified region covered by the block 40, 60 and 90 min after the nerve block compared to baseline	90 minutes
Secondary	Pain relief 45 min after the nerve block	Pain relief 45 min after the nerve block using a 6-point verbal scale ranging from worse pain to no, little, moderate, good and complete pain relief (-1 to 4)	45 minutes
Secondary	Pain extent [% of body surface on standardized pain drawings] 50 minutes after the nerve block	Pain extent will be mapped on standardized pain drawings 50 minutes after the nerve block compared to baseline	50 minutes
Secondary	Pain descriptors 50 minutes after the nerve block	Pain descriptors (burning, squeezing, pins and needles, tingling, stabbing, electrical shocks) are captured 50 minutes after the nerve block compared to baseline	50 minutes
Secondary	Area [% of pain extent] of hypersensitivity to thermal and nociceptive stimuli	Area of hypersensitivity [% of pain extent] to warm (40°C) and cold (20°C) thermo rollers (Somedic AB, Hörby, Sweden), pinprick (Semmes-Weinstein monofilament no 5.88 (bending force 75.9 g/745 mN)), and brush (SENSELab Brush-05; Somedic AB, Hörby, Sweden), if any, 55 and 95 min after nerve block compared to baseline	95 minutes
Secondary	Intensity of hypersensitivity on Numerical Rating Scale (NRS) [0-10, 0=no pain 10=worst pain imaginable] to thermal and nociceptive stimuli	Intensity of hypersensitivity on Numerical Rating Scale (NRS) [0-10, 0=no pain 10=worst pain imaginable] to warm (40°C) and cold (20°C) thermo rollers (Somedic AB, Hörby, Sweden), pinprick (Semmes-Weinstein monofilament no 5.88 (bending force 75.9 g/745 mN)), and brush (SENSELab Brush-05; Somedic AB, Hörby, Sweden), if any, 55 and 95 min after nerve block compared to baseline	95 minutes