Percutaneous Electrical Nerve Stimulation As Alternative To Nerve Blocks In Anesthesia, Pain Medicine And Rehabilitation Of Nonspecific Chronic Pain
Not yet recruitingPhase 4NCT07273006
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 anesthetic…
Study details
- Official title
- Percutaneous Electrical Nerve Stimulation As Alternative To Nerve Blocks In Anesthesia, Pain Medicine And Rehabilitation Of Nonspecific Chronic Pain
- Conditions
- Non-specific Low Back Pain (NSLBP)
- Facet Joint Syndrome
- Interventions
- Drug: Nerve block with Lidocain
- Device: Percutaneous electrical nerve stimulation
- Other: Sham Block
- Sponsor
- Universidad Complutense de Madrid
- Collaborators
- Universidad Francisco de Vitoria; Medical University of Warsaw; Jagiellonian University
- Start date
- 2026-09-01
- Primary completion
- 2028-11-01
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Poland
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Participants with chronic LBP lasting at least three months and clinical suspicion of facet joint pain. * A balanced sex distribution and a wide range of body mass index (BMI) will be promoted to allow subgroup analyses and to explore potential associations between obesity and procedural complications, thus strengthening the external validity of the study. This demographic selection is justified by prevalence patterns reported in the literature and by the need to capture clinically relevant effect modifiers in real clinical environments. * The suspicion of facet joint pain will be based on a compatible axial clinical pattern and the absence of objective neurological deficit, considering that neither physical examination nor imaging tests provide sufficient specificity. Therefore, diagnostic confirmation will be performed functionally through ultrasound-guided medial branch diagnostic blocks, which are the most reliable tool for attributing pain to the facet joint. The dual innervation of each lumbar facet joint will be considered; thus, two adjacent levels will be blocked per joint (the medial branch at the affected level and the one immediately above). * Eligible patients will be those with a positive functional screening in two independent medial branch diagnostic blocks performed with anesthetics of different duration, in separate sessions, to reduce false positives. * The diagnosis will be confirmed in cases reporting clinically relevant pain relief within the expected pharmacological window. Exclusion Criteria: * Exclusion criteria will include red flags or specific etiologies such as infection, neoplasm, fracture, or cauda equina syndrome, as well as patients with progressive motor radiculopathy or another demonstrated neuropathic pain source other than facet origin. * Individuals who have undergone prior procedures that could compromise response interpretation such as recent radiofrequency denervation, cryoneurolysis or intra-articular corticosteroid injections within a period that could extend analgesic effects.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07273006