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

Study acronym: PENSAR
StatusNot Yet Recruiting
PhasePhase 4
Started
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Record History

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  1. Minor Secondary endpoints: details revised at 1 of 4 entries
    • Eligibility criteria shortened, about 4 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07273006
Lead Sponsor Universidad Complutense de Madrid
Collaborators: Universidad Francisco de Vitoria, Medical University of Warsaw, Jagiellonian University
Conditions
(from sponsor)
Non-specific Low Back Pain (NSLBP), Facet Joint Syndrome
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov