TREATMENT OF CHRONIC PAIN BY NEUROMODULATION WITH LOCAL ANESTHETIC (NEURALTHERAPY) IN OPERATED AND / OR IRRADIATED PATIENTS FOR HEAD AND NECK, BREST AND, INTRATHROCIC NEOPLASM - LIDO-CLOR

Conditions: CHRONIC PAIN IN OPERATED AND / OR IRRADIATED PATIENTS FOR HEAD AND NECK, BREST AND, INTRATHROCIC NEOPLASM
MedDRA version: 9.1Level: LLTClassification code 10039581Term: Scar conditions and fibrosis of skin

Registration Number: EUCTR2008-002085-63-IT

Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.previous surgery or surgery + radiation + chemotherapy, with treatment completed at least 30 days for head-neck, lung and breast cancer;
2. Age ≥ 18;
3. Patients in good general condition without active disease of the main organs (heart, lung, liver, kidney);
4. writing and signed Informed consent obtained before starting protocol procedures .
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. active uncontrolled Infection, including human immunodeficiency virus (HIV);
2. drug abuse;
3. allergic reaction to some component of the treatment;
4. Medical or psychological condition that not allow the patient to complete the study or to understand and sign informed consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the effectiveness of neuromodulation with Lidocaina Cloridrato in the treatment of chronic pain and functional recovery postsurgery of patients treated for head and neck, breast and INTRATHROCIC tumors.;Secondary Objective: 1. Assessment of quality of life 2. Assessment of costs about this type of therapy. <br>3. Evaluation of toxicity;Primary end point(s): 1. Percentage improvement on the scale VAS pain. <br>2. Time improvement / remission defined as the time between the date of start of treatment with neuralterapy AL and the first clinical signs subjective and / or objective improvement in pain and function. <br>3. Improved assessment physiatric parameters.

Secondary Outcome Measures