2024-519832-17-00招募中2 期
Perineural incobotulinumtoxin-A for Complex Regional Pain Syndrome - An open-label feasibility study (PINCom)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Overall feasibility analysis of a full scale trial, based on patient and investigator feedback, recruitment-, inclusion- and, completion- percentages and rates
研究概览
简要总结
To evaluate the feasibility and safety of perineural administration of incobotulinumtoxinA (Xeomin) in patients with unilateral CRPS type I or II, in preparation for a future controlled efficacy trial.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Active intervention
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participant is 18 years of age or older.
- •Participant has a diagnosis of CRPS type I or II affecting one upper or one lower limb which 1) meets the Budapest Research Criteria and 2) has been present for at least 6 months
- •CRPS is rated by the participant as their primary pain condition.
- •Analgesic treatment, including rescue medications, has been stable for at least one month prior to study entry and will be maintained throughout the study.
- •Female participants of childbearing potential agree to use an effective and approved method of contraception during the study period.
- •Participant can speak, read, and understand Danish.
排除标准
- •Participant has a known allergy to incobotulinumtoxinA (BoNT-A).
- •Participant is actively using illicit drugs.
- •Participant is pregnant, breastfeeding, or planning pregnancy during the study period.
- •Participant has any other condition or circumstance that the investigator considers incompatible with safe and complete study participation.
- •Participant has received any BoNT-A treatment within 3 months prior to study start.
- •Participant has a diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or other conditions that impair accurate pain assessment.
- •Participant has an active infection in the affected limb.
- •Participant plans to initiate physical therapy, psychotherapy, or other non-pharmaceutical pain treatments during the study.
- •Participant has used topical analgesics (e.g. lidocaine patches) on the affected area within 1 week of study start.
- •Participant has been treated with capsaicin patches on the affected area within 3 months of study start.
- •Participant has psychiatric comorbidities that, in the investigator’s opinion, may interfere with participation.
- •Participant consumes alcohol above the recommended limits set by the Danish Health Authority.
结局指标
主要结局
Overall feasibility analysis of a full scale trial, based on patient and investigator feedback, recruitment-, inclusion- and, completion- percentages and rates
Overall feasibility analysis of a full scale trial, based on patient and investigator feedback, recruitment-, inclusion- and, completion- percentages and rates
次要结局
- Documentation of flare-up symptoms post-injection
- Qualiative analysis of patient interviews on treatment, effects, and participation burden.
- Estimates of effect size on pain reduction for use in future power calculations.
研究者
Marc Klee Olsen
Scientific
Rigshospitalet
研究点 (1)
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