Botulinum Toxin for Chronic Neuropathic Pain - an Interventional Open Label Study at the Interdisciplinary Pain Center, Zealand University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximal pain intensity
研究概览
简要总结
Treatment of peripheral neuropathic pain with Botulinum Toxin (BoNT) has showed promising results since the first study was released in 2001. Further research, however, is needed in order to strengthen the treatment, and a number of questions are unanswered. This includes which indication is the treatment the most effective, how should the treatment be administered, what is the duration of the effect? This study is a prospective interventional open label study, designed to assess the efficacy and safety of Botolinum toxin in the treatment of chronic neuropathic pain.
详细描述
Background:
There are eight randomized controlled trials investigating the effectiveness of BoNT for peripheral neuropathic pain. The indications in the studies include diabetic neuropathy, post-herpetic neuropathy, and peripheral nerve injury. Overall, the studies indicate a treatment effect that is significantly better than placebo. However, the studies are relatively small, their outcome measures vary, making comparison difficult, and there is considerable variation in the degree of pain reduction. The duration of the effect of BoNT treatment varies greatly and has not been systematically studied. The current evidence provides a promising background in the treatment of BoNT og neuropathic pain, but further research and documentation are needed.
At the Interdisciplinary Pain Center, Zealand University Hospital, BoNT treatment is already used for patients with neuropathic pain, who do not respond to 1. and 2. line treatments. This study will evaluate the efficacy of the treatment.
Method:
The objective of this study is to prospectively follow a one-year cohort and subsequently conduct a follow-up of 7 months (three treatments) for patients initiating BoNT treatment. The follow-up includes monitoring the treatment's effectiveness, duration, and recording adverse reactions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Condition of neuropathic pain verified by paraclinical examination or supported by underlying diseases (e.g., diabetes or herpes zoster).
- •The condition is characterized by allodynia, hyperalgesia, and/or neuralgiform symptoms such as burning and stabbing pain.
- •The affected area can be identified through objective examination with detection of disturbances in touch using cotton swabs, pin-prick, and/or vibration
排除标准
- •Mixed etiology of pain not solely attributable to neuropathy (e.g., fibromyalgia and neuropathy or nociceptive pain and neuropathy).
- •Contraindication to BoNT treatment (allergy to the toxin).
- •Pregnancy.
- •Diseases where BoNT treatment is contraindicated, such as motor neuron diseases and muscular dystrophy.
- •Severe psychiatric disorder.
研究组 & 干预措施
Intervention group
Patients treated with Botulinum Toxin
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Maximal pain intensity
时间窗: At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).
Proportion of patients with clinically relevant reduction in maximum pain (last 24 hours) compared to baseline, assessed using the Numerical Rating Scale (NRS 0-10; Zero represents 'no pain at all' and the upper limit represents 'the worst pain ever possible'). A minimal important difference (MID) of NRS 1 is considered as clinically relevant.
pain intensity at rest
时间窗: At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®)
Proportion of patients with clinically relevant reduction in average pain at rest (last 24 hours) compared to baseline, assessed using the Numerical Rating Scale (NRS 0-10). A MID of NRS 1 is considered as clinically relevant.
Frequency of serious adverse reactions
时间窗: Up to 7 months after initiating treatment
Frequency of serious adverse reactions (according to ICH-GCP definition).
Frequency of serious adverse events
时间窗: Up to 7 months after initiating treatment
Frequency of serious adverse events (according to ICH-GCP definition).
次要结局
- Onset and duration(At 28 days)
- EuroQol-5 Dimension (EQ-5D)(At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).)
- Neuropathic Pain Symptom Inventory (NPSI)(At 28 days, 4 months, and 7 months after initiating treatment with BoNT type A (Xeomin®).)
研究者
Rune Frederiksen
Principal Investigator
Region Zealand