A Dose-response, Randomized, Double-blind Study to Evaluate the Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures

Hopital Foch1 个研究点分布在 1 个国家目标入组 14 人开始时间: 2011年6月最近更新: 2017年5月25日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Hopital Foch
入组人数: 14
试验地点: 1
主要终点: Cervical mobility degree

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main objective of the study is to estimate the efficiency and to determine the optimal dose of Botulinum toxin A, administered by intramuscular way in cervical spasms after radiotherapy, as well as the optimal sites for these injections.

The concerned muscular groups are the sternocleidomastoid (SCM), the trapezius muscle and the splenius capitis.

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, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients from 18 to 75 years old;
•malignant Tumor of aerodigestive ways, in forgiveness;
•Treatment containing the external radiotherapy ended since > 6 months
•Life expectancy > 6 months;
•patient complaining from cervical spasms with functional disability;
•Negative Pregnancy test;
•Women under effective contraception;
•Patients benefiting from a national insurance scheme;
•Patient having given a written consent.

排除标准

•Cervico-facial Surgery with reconstruction by pedicled flap
•Implantable Chamber with catheter in the internal jugular vein near the spasm;
•Muscular, neurological Pathology or malformative pulling a disorder of perception of the pain, an amyotrophy, a muscular weakness affecting the cervical axis or the upper limbs;
•Disorder generalized by the muscular activity (ex myasthenia);
•Cervical osseous or muscular Pathology pulling pains and disability before the beginning of the treatment (cervical degenerative osteoarthritis diagnosed to the cervical radiography, the slipped disc);
•Previous cervical injection of botulinum toxin ;
•Local Infection at the level of one of the sites proposed for injection;
•Histories of epilepsy;
•Patients presenting a hypersensitivity to the botulinum neurotoxin A or in one of its excipients;
•Patients under anticoagulation therapy, Under antibiotic treatment by aminoglycosides or amino 4 quinoline, under myorelaxant treatment or that must undergo an intervention with curarisation;
•Patients for whom a surgical operation is planned in the zone interested in the treatment
•Pregnant or breast-feeding Women;
•Patients for whom questionnaires will not be assessable (handicaps of communication, patient not speaking French, etc.).

研究组 & 干预措施

Group D1

Experimental

Patients receiving the toxin in SCM and the placebo in trapezius muscle and splenius capitis. Patients receiving the dose of 30 units (U) at injection point, totalling 120 U.