Spinal Cord InjuriesNCT05646810
Impact of Peripheral Afferent Input on Central Neuropathic Pain
A study testing Lidocaine (10 mg/ml) and Isotonic saline in people with Spinal Cord Injuries and Spinal Cord Diseases, run by University of Aarhus.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Diseases, Syringomyelia
- What is being tested?
- Lidocaine (10 mg/ml) and Isotonic saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- Lidocaine (10 mg/ml), Isotonic saline
- Keywords
- central pain, peripheral afferent input, neuropathic pain, spinal cord injury
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases, Syringomyelia, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Isotonic salineDiagnostic test
Isotonic saline will be injected according to established protocols using ultrasound guidance and an aseptic technique by an experienced anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Nerve block Receives: Diagnostic Test: Lidocaine (10 mg/ml) |
| Isotonic saline | Placebo comparator | Nerve block Receives: Diagnostic Test: Isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 40 minutes
Secondary outcomes (6)
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
Measured: 90 minutes
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)
Measured: 45 minutes
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
Measured: 50 minutes
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
Measured: 50 minutes
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
Measured: 95 minutes
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
Measured: 95 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Rosner, MD, Principal investigator, Danish Pain Research Center, Department of Clinical Medicine, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646810
- Sponsor's protocol ID
- 39451
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Peripheral Afferent Input on Central Neuropathic Pain
- ClinicalTrials.gov ID
- NCT05646810
- Acronym / sponsor ID
- 39451
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases, Syringomyelia
- Keywords
- central pain, peripheral afferent input, neuropathic pain, spinal cord injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Diagnostic Test: Lidocaine (10 mg/ml)Nerve block |
| Isotonic saline | Placebo comparator | Diagnostic Test: Isotonic salineNerve block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Lidocaine |
| Isotonic salineIsotonic saline will be injected according to established protocols using ultrasound guidance and an aseptic technique by an experienced anesthesiologist. | Diagnostic test | Isotonic saline |
Primary outcome
Indication of most pain relief
Time frame: 40 minutes
Limb with most pain relief on Numerical Rating Scale (NRS) [0-10, 0=no pain 10=worst pain imaginable] 40 minutes after nerve block
6 secondary outcomes
Intensity on Numerical Rating Scale (NRS) [0-10, 0=no pain 10=worst pain imaginable] of spontaneous pain
Time frame: 90 minutes
Pain relief 45 min after the nerve block
Time frame: 45 minutes
Pain extent [% of body surface on standardized pain drawings] 50 minutes after the nerve block
Time frame: 50 minutes
Pain descriptors 50 minutes after the nerve block
Time frame: 50 minutes
Area [% of pain extent] of hypersensitivity to thermal and nociceptive stimuli
Time frame: 95 minutes
Intensity of hypersensitivity on Numerical Rating Scale (NRS) [0-10, 0=no pain 10=worst pain imaginable] to thermal and nociceptive stimuli
Time frame: 95 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Rosner, MD principal investigator
Danish Pain Research Center, Department of Clinical Medicine, Aarhus University
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine (10 mg/ml) and Isotonic saline in people with Spinal Cord Injuries and Spinal Cord Diseases, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nanna B. Finnerup, Professor (0045 784 63380, finnerup@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indication of most pain relief (time frame: 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.