Effect of Intrathecal Baclofen (ITB) Bolus on Neuropathic Pain (NP) in Spinal Cord Injury (SCI) Patients. Preliminary Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Neuropathic Pain Inventory Scale (NPIS)
研究概览
简要总结
Hypothesis:
ITB bolus can have antinociceptive effect on neuropathic pain in spinal cord injury patients, which could depend on the subtype of pain, or on the lesion level, cervical or thoracic spinal cord injury.
Objective:
To study the effect of intrathecal baclofen bolus on neuropathic pain in patients with spinal cord injury at cervico-dorsal level.
Primary Endpoint:
Effect of intrathecal baclofen bolus in neuropathic pain (measured using the Neuropathic Pain Inventory Scale, the Brief Pain Inventory and the Numerical Rating Scale) in spinal cord injury at cervico-dorsal level.
Secondary Endpoints:
- Spasticity and spasms (measured using the Modified Ashworth Scale and the Visual Analogue Scale and Penn Spasm Frequency Scale).
- Neurophysiological examination (warm perception threshold, heat pain perception threshold, evoked pain perception and contact heat evoked potentials).
详细描述
The study will be a randomized, double-blind (patients and who will realize the clinical and neurophysiologic evaluation), placebo-controlled trial. We will recruit 10-12 patients with SCI with complete or incomplete lesion at cervical or thoracic level to be randomly distributed in two study groups: ITB bolus group and a placebo group.
In 6-8 months, we will administer an intrathecal baclofen bolus of 50 µg (1ml) in 5-6 SCI patients or 1ml of physiologic serum subcutaneously in the other 5-6 SCI patients.
Before the intrathecal baclofen or placebo bolus is administered, patients will be evaluated for neuropathic pain, using the Neuropathic Pain Inventory Scale, Brief Pain Inventory and Numerical Rating Scale. Spasticity and spasms will also be measured by the Modified Ashworth Scale, the Visual Analogue Scale and the Penn Spasm. After that, patients will also undergo, early in the morning when the intrathecal baclofen or placebo bolus will be administered, a neurophysiology assessment (warm perception threshold, heat pain perception threshold, evoked pain perception and contact heat evoked potentials).
After the neurophysiological evaluation, patients will receive an intrathecal baclofen bolus of 50 µg or placebo (randomization). After the intrathecal baclofen or placebo injection, a clinical and neurophysiological examination, of neuropathic pain and spasticity and spasms, will be repeated at 1, 2 and 4 hours after the bolus administration. Moreover, Kumru et al. (2013) reported that the 50 µg intrathecal baclofen bolus reduced the pain perception threshold and evoked acute pain perception in patients with SCI.
During all evaluation period, the patients continue with their analgesic, antispastic and/or any other stable medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-70 years and at least one year since the spinal cord injury.
- •Aetiology: stable SCI from traumatic or medical origin.
- •Patients with chronic refractory neuropathic pain and with spinal cord injury, both complete and incomplete, at the cervico-thoracic level.
- •Severity of pain equal or greater than 4 in the Numerical Rating Scale.
- •With spasticity (MAS>=).
- •Stable analgesic, antispastic and any other medication.
排除标准
- •Patients who do not give patient inform consent.
- •Contraindication for baclofen or intrathecal injection.
研究组 & 干预措施
intrathecal baclofen bolus
In ITB bolus group: An intrathecal baclofen bolus injection of 50 µg (1ml) will be injected at L3/L4 level. A 50 µg.
干预措施: Intrathecal baclofen bolus (Drug)
placebo
In the placebo group: 1 ml of physiological saline (isotonic saline) will be injected subcutaneously at L3/L4 level simulating
干预措施: Placebo (Other)
结局指标
主要结局
Neuropathic Pain Inventory Scale (NPIS)
时间窗: Change from baseline in neuropathic pain at 4hours
a self-questionnaire specifically designed to evaluate the different symptoms of neuropathic pain and includes 10 descriptors that allow discrimination and quantification of five distinct clinically relevant dimensions of neuropathic pain syndromes and that are sensitive to treatment
次要结局
- Visual Analogue Scale (VAS) for spasticity(Change from baseline in spasticity at 4 hours)
- Modified Ashworth Scale (MAS)(Change from baseline in spasticity at 1, 2 and 4hours)
- Modified Penn Spasm Frequency Scale(Change from baseline in spasticity at 4hours)
- warm and heat pain perception threshold(Change from baseline in warm and pain perception at 4hours)
- contact heat evoked potentials.(Change from baseline in evoked potential with heat pain at 4hours)
- Brief Pain Inventory (BPI)(Change from baseline in pain at 4hours)
- evoked pain perception(Change from baseline in evoked acute pain perception at 4hours)
- Numerical Rating Scale (NRS) for neuropathic pain(Change from baseline in pain at 4hours)
研究者
Hatice Kumru
MD PhD
Institut Guttmann