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

NCT07273006 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: UComplutenseMadrid-PENSAR
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Facet Joint Syndrome; Non-specific Low Back Pain (NSLBP)

Keywords

musculoskeletal ultrasound imaging; health care cost-utility; safety and adverse events; randomized clinical trial; pain neuromodulation; diagnostic nerve blocks; percutaneous electrical nerve stimulation; facet joint syndrome; non-specific low back pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  The primary variable will be immediate analgesic response, defined as a ≥50% reduction in the Numerical Pain Rating Scale (NPRS, 0-10). Lower scores indicate less pain intensity.

  From baseline within the pre-specified time window for each intervention (two post-intervention assessments will be performed in all groups at 15 and 45 minutes) and maintained at 7 days

Secondary Outcomes (4)

• Pain during specific movements

  Baseline, 45 minutes, and 7 days

• Pressure pain threshold

  Baseline, 45 minutes, and 7 days

• Analgesic drug consumption

  From 3 months before the study until 7 days after the intervention.

• Participants' satisfaction

  After 7 days

Other Outcomes (1)

• Record of local and systemic adverse events

  Baseline, 7 days

Study Arms (4)

PENS

EXPERIMENTAL

A single ultrasound-guided session will be applied using fine solid needles (0.32 mm diameter), accounting for dual innervation. Electrical parameters will be fixed within recommended ranges (10 Hz, 250 µs, current intensity sufficient to produce a strong but tolerable sensation below the motor threshold using a standardized ramp, and session duration of 20 minutes).

Device: Percutaneous electrical nerve stimulation

Nerve block

ACTIVE COMPARATOR

Two adjacent levels per joint will be blocked in a single session. After minimal intradermal infiltration for local anesthesia, a sterile 25G-22G needle will be inserted in-plane toward the target under continuous visualization. Before administering the drug in opaque syringes, negative aspiration and fractional injection will be performed, confirming the absence of abnormal resistance or radiating pain. The diagnostic injectate will be a local anesthetic without corticosteroid (1% lidocaine) with low volumes of 0.5 ml per branch to limit diffusion.

Drug: Nerve block with Lidocain

PENS + nerve block

ACTIVE COMPARATOR

Both procedures will be performed in a single visit (first PENS, followed by the nerve block) following the same procedures described above

Drug: Nerve block with Lidocain; Device: Percutaneous electrical nerve stimulation

PENS + placebo block

SHAM COMPARATOR

In the same visit, PENS will be applied following the same described protocol, and the full ritual of the nerve block will be reproduced. However, in this group, no active drug will be administered (a minimal volume of inert solution will be injected into the subcutaneous/superperiosteal plane to mimic the injection sensation without depositing perineural anesthetic).

Device: Percutaneous electrical nerve stimulation; Other: Sham Block

Interventions

Nerve block with Lidocain DRUG

Two adjacent levels per joint will be blocked in a single session. After minimal intradermal infiltration for local anesthesia, a sterile 25G-22G needle will be inserted in-plane toward the target under continuous visualization. Before administering the drug in opaque syringes, negative aspiration and fractional injection will be performed, confirming the absence of abnormal resistance or radiating pain. The diagnostic injectate will be a local anesthetic without corticosteroid (1% lidocaine) with low volumes of 0.5 ml per branch to limit diffusion

Nerve block; PENS + nerve block

Percutaneous electrical nerve stimulation DEVICE

A single ultrasound-guided session will be applied using fine solid needles (0.32 mm diameter), accounting for dual innervation. Electrical parameters will be fixed within recommended ranges (10 Hz, 250 µs, current intensity sufficient to produce a strong but tolerable sensation below the motor threshold using a standardized ramp, and session duration of 15-20 minutes)

PENS; PENS + nerve block; PENS + placebo block

Sham Block OTHER

The full ritual of the nerve block will be reproduced. However, in this group, no active drug will be administered (a minimal volume of inert solution will be injected into the subcutaneous/superperiosteal plane to mimic the injection sensation without depositing perineural anesthetic)

PENS + placebo block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Universidad Francisco de Vitoria: collaborator
• Medical University of Warsaw: collaborator
• Jagiellonian University: collaborator

Study Sites (1)

Medical University of Warsaw

Warsaw, Warszawa, 02-091, Poland

Location

Related Publications (17)

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MeSH Terms

Interventions

Nerve Block; Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia

Study Officials

• Juan Antonio Valera-Calero, PhD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Antonio Valera-Calero, PhD

CONTACT

0034 653 766 841; juavaler@ucm.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor would be a different investigator blinded to the interventions
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Health Sciences

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

PL (1)