2022-500727-68-01招募中2 期
Perineural injections of incobotulinumtoxin-A for diabetic neuropathic pain of the lower extremities: A double-blind, randomized, placebo-controlled study (PINBOT)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Efficacy of pain relief of bilateral perineural injections of incobotulinumtoxin-A around the distal ischial nerve. The primary outcome will be tested using a generalised linear mixed model of repeated measures of daily (or weekly means) of pain scores (NRS), comparing active and placebo groups for 24 weeks, with the mean baseline pain score of each group as a covariate.
研究概览
简要总结
This study will investigate the efficacy and safety of bilateral perineural incobotulinumtoxinA (iBonT-A) injections in persons with diabetic neuropathic pain of the lower extremities.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Monitor, Subject, Analyst, Investigator)
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
- •18 years of age or older
- •Diagnosed with diabetes mellitus, type I or II
- •Diagnosed with diabetic neuropathic pain that is a) by the participant as their dominant overall dominant pain b) rated at least 4 out of 10 of the NRS pain scale in both legs on average over the past 7 days c) fulfils the IASP criteria for Definite chronic neuropathic pain d) has been verified using nerveconduction studies e) present in both legs, below the knee f) has been present for at least 6 months
- •In a stable analgesic treatment regime for at least 1 month prior to inclusion and for the duration of the study
- •Not been treated with topical agents such as capsaicin or lidocaine products in the affected areas for at least 3 months prior to inclusion
- •Using an approved, safe contraceptive (for premenopausal women)
- •Speak, read, and understand Danish
排除标准
- •A known allergy or hypersensitivity to botulinumtoxin
- •Using or receiving treatment with cannabis products of any kind
- •Pregnant or planning pregnancy during the study period
- •A score of more than 25 on the Charlson Comorbidity Index
- •Treated with botulinumtoxin in the last 6 months
- •Diagnosed with myasthenia, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- •A known malignant condition
- •An ongoing infection in the area of injection (right above the knee joint)
- •Expect to change their pain medication during the study period
- •Diagnosed with a competing cause of central or peripheral neuropathic pain, or other painful chronic conditions of the lower extremities, such as spinal stenosis, claudicatio, previous traume or nerve injury or cancer related pain.
- •A psychiatric condition that affects their completion of the study, as assessed by the investigator.
- •Active abusers of alcohol or illegal substances
结局指标
主要结局
Efficacy of pain relief of bilateral perineural injections of incobotulinumtoxin-A around the distal ischial nerve. The primary outcome will be tested using a generalised linear mixed model of repeated measures of daily (or weekly means) of pain scores (NRS), comparing active and placebo groups for 24 weeks, with the mean baseline pain score of each group as a covariate.
Efficacy of pain relief of bilateral perineural injections of incobotulinumtoxin-A around the distal ischial nerve. The primary outcome will be tested using a generalised linear mixed model of repeated measures of daily (or weekly means) of pain scores (NRS), comparing active and placebo groups for 24 weeks, with the mean baseline pain score of each group as a covariate.
次要结局
- QST: Sensory profiles will be generated for each QST sample as stipulated by the DFNS protocol. Accordingly, recorded values will be z-transformed by subtracting the mean value of an age- and sex matched reference group. Z-scores of >1.96 or <−1.96 i.e., falling outside the 95% confidence interval for matched healthy controls, will be considered abnormal. Absolute scores will also be compared before and after treatment, and between the two groups.
- Muscle power: Muscle power of the lower extremities over time for active and placebo groups will be compared to baseline and between groups using a generalised linear mixed-model of repeated measures, with pre-treatment baseline values as a covariate.
- HR-QoL:EQ-5D-5L visual analogue scale of self-perceived health scores for active and placebo groups will be compared to baseline and between groups using a generalised linear mixed-model of repeated measures, with pre-treatment baseline values as a covariate.
- ADL: COPM scores for active and placebo groups will be compared to baseline and between groups using a generalised linear mixed-model of repeated measures, with pre-treatment baseline values as a covariate.
- Depression: BDI-II total- and subscores for active and placebo groups will be compared to baseline and between groups using a generalised linear mixed-model of repeated measures, with pre-treatment baseline values as a covariate.
- Physical activity: PAS-2-DK scores for active and placebo groups will be compared to baseline and between groups using a generalised linear mixed-model of repeated measures, with pre-treatment baseline values as a covariate.
- Rescue medication: Average days with use of rescue medication per week for active and placebo groups will be compared to baseline and between groups using a generalised linear mixed-model of repeated measures, with pre-treatment baseline values as a covariate.
- Neuropathic pain symptoms: NPSI total and subscores for active and placebo groups will be compared to baseline and between groups using a generalised linear mixed-model of repeated measures, with pre-treatment baseline values as a covariate.
研究者
Neurological Pain Clinic, Rigshospitalet Glostrup
Scientific
Rigshospitalet
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Repeated Botulinum Toxin Type A Injections on Intramuscular Fat Accumulation in Individuals With Sleep Bruxism.BruxismNCT07266064Melek Volkan Yazici27
招募中
1 期
Perineural injections of incobotulinumtoxin-A for diabetic neuropathic pain of the lower extremities: A double-blind, randomized, placebo-controlled study (PINBOT)Diabetic neuropathic painMedDRA version: 21.1Level: LLTClassification code: 10067547Term: Diabetic peripheral neuropathic pain Class: 10029205CTIS2022-500727-68-01Rigshospitalet80
招募中
3 期
Safety and efficacy of botulinum toxin A in patients with posttraumatic headache: a double-blind, randomized, placebo-controlled, parallel-group trial and investigation of neuro-inflammatory biomarkers as predictors of efficacy.2024-515901-24-00Rigshospitalet80
进行中（未招募）
不适用
Intra-articular injection of botulinum toxin for treatment of shoulder pain after stroke.hemiplegic shoulder painMedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2011-004682-32-ITFONDAZIONE ISTITUTO SAN RAFFAELE-G.GIGLIO
尚未招募
2 期
Injection Botulinum Toxin in post-surgery wound healingCTRI/2024/03/064416Intraumural Grant