Conditioned Autologous Serum Therapy (Orthokine) on the dorsal root ganglion in patients with chronic radiculalgia (RADISAC) - RADISAC

DARYD0 个研究点目标入组 50 人开始时间: 2021年11月16日最近更新: 2021年11月29日

适应症

试验速览

暂无简介。

•Patients older than 18 years, not illiterate, with lower limb radicular pain of more than 6 months.
•Unilateral, mono and / or bisegmental radicular pain of a lower limb lasting at least more than 6 months.
•In case of having received treatment previously, at least 3 months must have passed since the last therapy received (infiltration, radiofrequency or surgery) and the pain persist in the same territory.
•Present lumbar Nuclear Magnetic Resonance (NMR), Electromyography (EMG) done concomitantly to the pain that the patient presents at the time of inclusion in the study.
•Present a score greater than 5 in the DN4 questionnaire at the time of inclusion in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•exclusion criteria:
•Refusal of the patient to participate in the study or not to sign the informed consent
•Allergy to intravenous iodinated contrast and / or local anesthetics.
•Impossibility of the patient to maintain the prone position.
•Systemic or local infection at the puncture site.
•Present any of the following symptoms: atypical radiation pattern, bilateral involvement, involvement of more than two segments or roots.
•Concomitant pathological history during study / therapy: oncological disease, vertebral fractures, myelopathy, systemic disease, connective tissue disease, coagulation disorder, multiple sclerosis, osteomyelitis, or bone edema.
•Pregnancy or breastfeeding
•Previous treatment with spinal neurostimulator placement
•Previous treatment with brain stimulator for treatment of epilepsy or Parkinson's disease.
•Cardiac pacemaker carrier.
•Patient who does not attend any of the treatment sessions for unjustified reasons.

发起方

DARYD