lower extremity radicular pain
Conditions
Interventions
Trade Name: Orthokine
Product Name: Orthokine
Product Code: PS-8229-2010
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe
Pharmaceutical form of the placebo: Solution for inj
Sponsors
DARYD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients older than 18 years, not illiterate, with lower limb radicular pain of more than 6 months. Inclusion criteria: 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether therapy with conditioned autologous serum on the dorsal root ganglion reduces neuropathic pain in patients with persistent lower limb radiculalgia;Secondary Objective: Assess the degree of improvement of neuropathic pain and its symptoms Evaluate the functionality of these patients at 30 days, at 3 months and at 6 months, at 12 months. To assess the quality of life of these patients at 30 days, 3 months, 6 months and 12 months. Assess the mood of these patients at 30 days, 3 months, 6 months and 12 months.;Primary end point(s): Pain improvement of at least 20%;Timepoint(s) of evaluation of this end point: 30 days after therapy At 3 months after therapy At 6 months after therapy At 12 months after therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 20% improvement in evaluative tests: Oswestry test Quality of life test SF 12 Mood Assessment Test;Timepoint(s) of evaluation of this end point: 30 days after therapy At 3 months after therapy At 6 months after therapy At 12 months after therapy | — |
Countries
Spain
Contacts
Public ContactDARYD
DARYD
Outcome results
None listed