drugset
drugset / Trial / NCT07273006

Percutaneous Electrical Nerve Stimulation As Alternative To Nerve Blocks In Anesthesia, Pain Medicine And Rehabilitation Of Nonspecific Chronic Pain

NCT07273006 ↗

Phase 4 Not yet recruiting 82 enrolled Universidad Complutense de Madrid Jagiellonian University · collabMedical University of Warsaw · collabUniversidad Francisco de Vitoria · collab
RandomizedParallel-groupSingle-blindDiagnostic

Summary

Chronic musculoskeletal pain of non-specific origin affects approximately 30% of the global population. Beyond its prevalence, it represents a serious health and socioeconomic problem. It is considered the leading cause of years lived with disability and is characterized by persistent functional limitation, deterioration of quality of life, and poorer mental health, with a high comorbidity of depression, anxiety, and sleep disorders, as well as a greater risk of suicidal ideation and behavior. From a socioeconomic perspective, chronic pain entails an impact of up to USD 635 billion annually just in United States (USA). In fact, spinal pain alone represents the condition with the highest direct costs (around USD 134.5 billion in USA) and additional indirect costs due to absenteeism and presenteeism, which impair productivity and work performance. These figures are expected to be substantially higher when considered at a global scale. One of the main aggravating factors of this condition is that in up to 90% of patients experiencing pain there is no identifiable anatomopathological substrate that reliably explains the symptoms (non-specific pain). Radiological findings are extremely common in asymptomatic populations, and making diagnostic or therapeutic decisions based on such findings, promotes overdiagnosis and low-value clinical cascades. It is estimated that up to 50% of imaging requests and 60% of spinal surgeries6 are unnecessary or unjustified. For this reason, Clinical Practice Guidelines recommend prioritizing interventional diagnostic techniques based on functional criteria over the interpretation of radiological findings, as they allow for more sensitive and specific identification of nociceptive sources (with a recommendation grade I-II). In this context, the motivation of the project is to study PENS as a non-pharmacological, safe, and transferable alternative to nerve blocks, reducing the risk of complications associated with the use of local anesthetics/corticosteroids and large-gauge needles. According to recent systematic reviews and meta-analyses confirming immediate analgesic responses, PENS could be a feasible alternative that maintains functional diagnostic and therapeutic value with a generally mild adverse-event profile and lower cost.

Timeline

Start
2026-09-01
Primary completion
2028-11-01
Completion
2029-08-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lidocaine Other / unclassified 0.5 ml Other
Comparator Lidocaine Other / unclassified 1 % Other

Indications

arthropathy