Impact of Peripheral Afferent Input on Central Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Indication of most pain relief
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Indication of most pain relief
时间窗: 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
次要结局
- Intensity on Numerical Rating Scale (NRS) [0-10, 0=no pain 10=worst pain imaginable] of spontaneous pain(90 minutes)
- Pain descriptors 50 minutes after the nerve block(50 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)
- Area [% of pain extent] of hypersensitivity to thermal and nociceptive stimuli(95 minutes)
- Intensity of hypersensitivity on Numerical Rating Scale (NRS) [0-10, 0=no pain 10=worst pain imaginable] to thermal and nociceptive stimuli(95 minutes)