Perineural Incobotulinumtoxin-A for Complex Regional Pain Syndrome - An Open-label Feasibility Study (PINCom)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
Complex Regional Pain Syndrome (CRPS) is a chronic pain condition characterized by severe regional pain, sensory disturbances, and functional impairment. Current treatment options are limited, and many patients experience substantial pain-related disability and symptom fluctuations, including flare-ups triggered by invasive procedures.
Perineural administration of botulinum toxin A has shown analgesic effects in other neuropathic pain conditions and may represent a less painful alternative to subcutaneous injection techniques. However, the feasibility, tolerability, and safety of perineural botulinum toxin administration in patients with CRPS have not been systematically evaluated.
The PINCom study is a single-center, open-label feasibility study designed to assess the safety, tolerability, and practical feasibility of ultrasound-guided perineural injection of incobotulinumtoxin-A in patients with unilateral chronic CRPS affecting an upper or lower limb. Participants receive a single perineural injection targeting major sensory nerves supplying the affected limb and are followed for 12 weeks.
Primary outcomes focus on feasibility metrics, including recruitment, retention, adherence, and data completeness, as well as safety outcomes, including serious adverse events and procedure-related complications. Tolerability is assessed through monitoring of CRPS flare-ups and a dedicated qualitative interview exploring participant experience. Exploratory outcomes include pain intensity, CRPS severity, and patient-reported measures collected to inform the design of a future randomized controlled trial.
详细描述
The PINCom study is a single-center, open-label feasibility study designed to evaluate the practical feasibility, safety, and tolerability of ultrasound-guided perineural injection of incobotulinumtoxin-A in adults with unilateral CRPS of an upper or lower limb. Depending on the anatomical distribution of symptoms, injections are administered at the supraclavicular brachial plexus (upper limb) or at distal sciatic and/or femoral nerve targets (lower limb). All procedures are performed under ultrasound guidance in a single treatment session.
The primary objective of the study is to determine whether a larger randomized controlled trial of perineural incobotulinumtoxin-A in CRPS is feasible at the study center. Feasibility outcomes include recruitment rate, screening-to-enrollment ratio, retention, adherence to study visits and daily pain diary completion, and completeness of outcome data.
Safety is assessed through monitoring of serious adverse events and targeted screening for procedure-related complications, potential nerve injury, and signs of systemic botulinum toxin spread. Adverse events are recorded throughout the study period. Given the clinical characteristics of CRPS, flare-ups are monitored separately as a tolerability outcome rather than as a primary safety endpoint.
Tolerability and participant experience are evaluated using a combination of structured symptom monitoring and a semi-structured qualitative interview conducted during follow-up. The interview explores participants' experiences of the injection procedure, perceived burden of study participation, and acceptability of the intervention. This qualitative component is intended to inform protocol refinement and patient-centered trial design.
Exploratory clinical outcomes are collected to characterize symptom variability and inform future trial design. These include daily pain intensity ratings, CRPS Severity Score assessments, sensory symptom mapping, and patient-reported outcome measures assessing pain quality, psychological factors, physical function, and quality of life. These measures are not powered to assess efficacy but will be used to estimate variability and optimal outcome timing for a future definitive trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Are over the age of 18
- •Have a diagnosis of CRPS type 1 or 2 in either one upper or one lower extremity which fulfils the Budapest research criteria
- •Have had the condition for at least 6 months
- •Rate CRPS as their primary pain condition
- •Have been on a stable analgesic regimen, including any rescue medications, for at least 1 month prior to the study and intend to maintain this regimen throughout the study
- •For pre-menopausal females: are using a safe and approved contraceptive
- •Speak, read, and understand Danish
排除标准
- •Are allergic to botulinum toxin A
- •Have been treated with botulinum toxin A for any indication within 3 months prior to study start
- •Are diagnosed with myasthenia, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition which makes differentiation of CRPS-specific pain difficult
- •Have an ongoing infection in the affected limb
- •Do not intend to start physical therapy, psychotherapy, or any other non-pharmaceutical intervention aimed at reducing pain
- •Have used a topical analgesic treatment such as lidocaine patches within 1 week prior to study start or have been treated with capsaicin patches in the affected area within 3 months prior to study start
- •Have psychiatric comorbidities which are considered by the investigators to impact their ability to participate
- •Consume alcohol in excess of what is recommended by the Danish Health Ministry
- •Are active abusers of illicit narcotics
- •Are pregnant, lactating, or plan on becoming pregnant during the study period
- •Have any other condition or circumstance that, in the investigators' opinion, will hinder safe and timely participation and completion of the study
研究组 & 干预措施
Active
Open-label treatment with 200 U of perineural Xeomin, either around the brachial plexus or the distal ischial and saphenus nerves.
干预措施: Perineural Incobotulinumtoxin-A 200 U (Drug)
结局指标
主要结局
Recruitment rate
时间窗: From study start through Day 84 (12 weeks)
Number of participants enrolled over time in the study
Screening-to-enrolment ratio
时间窗: From study start through Day 84
Proportion of screened patients who are enrolled in the study.
Study completion rate
时间窗: Day -7 to 84
Proportion of enrolled participants completing the study per protocol
Completeness of study data
时间窗: Day -7 to 84
Proportion of expected study data successfully collected, including completion of scheduled study visits and daily pain diary entries.
次要结局
- Participant-reported acceptability and experience(From enrolment to day 42)
- Serious Adverse Events (SAEs)(From treatment (Day 0) through Day 84)
- CRPS flare-ups(From treatment (Day 0) through Day 84)
研究者
Bo Biering-Soerensen
Associate Professor
Rigshospitalet, Denmark