Randomized controlled trial to evaluate the effect of neurologic modulation associated with conventional pain treatment versus conventional pain treatment in cancer patients with moderate to severe pain

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2021
INTERVENTION: C23.888.592.612.212 Cellular neuromodulation therapy electromagnetic equipment (REAC technology), an application is made by a tissue nanoconductor in the shoulder and neck region or in the ear. 18‐cycle therapy three times a week, administration with protocols NPO (neuro postural optimization), NPPO (neuromodulation neuropsychophysic) ou ANM (antalgic neuro modulation) specific to each arm patients with oncologic moderate to severe pain , in use of weak or strong opioids 120 patients in total . each arm will have 40 patients CONDITION: C00‐D48 cronic pain intractable. malignant neoplasm localization unspecified R00‐R99 PRIMARY OUTCOME: Assess at least one level reduction in the depression, anxiety scale and stress 21 in the neuromodulation intervention arm; ; To assess pain perception change with at least 30% reduction in scale; Analog Visual Pain in the neuromodulation intervention arm; SECONDARY OUTCOME: Evaluate serum level of interleukins and its relation with the evolution of treatment in all subgroups ; Evaluate the reduction in the amount of rescue medication used by the patient during the study in the neuromodulation intervention arm; ; Evaluate the tolerability and safety of neuromodulation associated with analgesia classical; Improvement of quality of life measured by the Eastern Cooperative Oncology group questionnaire in the neuromodulation intervention arm; To evaluate the improvement of the degree of pain in the subgroup of patients with neuropathy in the neuromodulation intervention arm; INCLUSION CRITERIA: patients with malignant neoplasia with moderate to severe pain; use of World Health OrganizationlLadder level 2 or 3 analgesics; cause of pain should be primarily cancer or its treatment; Age upper 18 years; Eastern Cooperative Oncology group performance status minus than 3; proper cognitive function to correctly complete the questionnaires; Availability for blood sample collection for evaluation of inflammatory parameters
Epistemonikos ID: f488af6677219211f666887bb487c60af8d53788
First added on: Dec 20, 2022