Multi-Omics Characterization of Percutaneous Electrolysis in Low Back Pain

NCT07524010 | Enrolling By Invitation Phase 1

• 1 other identifier: C.I. 24/763-EC_P
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is a highly prevalent musculoskeletal condition and is frequently associated with structural and functional alterations of the lumbar multifidus muscle. Percutaneous electrolysis is an ultrasound-guided invasive physiotherapy technique increasingly used in the management of musculoskeletal pain; however, its underlying biological mechanisms remain poorly understood. The aim of this study is to investigate the biochemical and molecular effects of percutaneous electrolysis applied to the lumbar multifidus muscle in patients with low back pain. A multidisciplinary, blood-based multi-omics approach will be used to explore systemic biochemical changes induced by the intervention. In this preliminary controlled study, blood samples will be collected from participants before and after treatment and analyzed using proteomic and lipidomic techniques. Multivariate statistical and bioinformatic analyses will be performed to identify proteins, lipids, and metabolic pathways that are significantly modulated by percutaneous electrolysis compared with a control procedure. The results of this study are expected to contribute to a better understanding of the physiological and biochemical mechanisms of action of percutaneous electrolysis and to support the identification of potential blood biomarkers associated with its therapeutic effects in low back pain.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Blood proteomic profile

  The Blood Proteomic Profile is measured by collecting blood samples at two time points: pre-intervention (T1) and post-intervention (T2). The blood samples are processed to extract serum, which is then subjected to proteomic analysis using mass spectrometry (LC-MS/MS). Proteins are first depleted of abundant proteins using a specific depletion kit. The remaining proteins are digested and analyzed using an Orbitrap Fusion Lumos mass spectrometer coupled with a nano-UHPLC system. Protein identification and quantification are performed using Proteome Discoverer software, and the data are analyzed statistically to identify proteins with significant changes in concentration between pre- and post-treatment samples.

  Baseline (pre-intervention) , post-intervention (20min after the intervention)

Secondary Outcomes (2)

• Expressed blood lipidomic

  Baseline (pre-intervention) , post-intervention (20min after the intervention)

• Pain perception

  Baseline (pre-intervention) , post-intervention (20min after the intervention)

Study Arms (2)

Sham control

SHAM COMPARATOR

Participants assigned to this arm will undergo a sham procedure designed to mimic the experimental intervention. The procedure includes the same positioning, ultrasound guidance, needle insertion, and duration as the experimental arm; however, no electrical current will be delivered. Blood samples will be collected at the same pre- and post-procedure time points as in the experimental arm. This control condition is used to account for nonspecific effects related to needling and the procedural context.

Procedure: Sham

Percutaneous electrolysis

EXPERIMENTAL

Participants assigned to this arm will receive ultrasound-guided percutaneous electrolysis applied to the lumbar multifidus muscle. After baseline blood sample collection, a fine needle will be inserted into the target muscle under ultrasound guidance and connected to a medical device delivering a low-intensity galvanic current. The intervention consists of multiple stimulation cycles separated by short rest periods. A post-treatment blood sample will be collected after a predefined time interval to assess biochemical changes induced by the intervention.

Procedure: Percutaneous electrolysis

Interventions

Percutaneous electrolysis PROCEDURE

Participants assigned to this arm will receive ultrasound-guided percutaneous electrolysis applied to the lumbar multifidus muscle. After baseline blood sample collection, a fine needle will be inserted into the target muscle under ultrasound guidance and connected to a medical device delivering a low-intensity galvanic current. The intervention consists of multiple stimulation cycles separated by short rest periods. A post-treatment blood sample will be collected after a predefined time interval to assess biochemical changes induced by the intervention.

Percutaneous electrolysis

Sham PROCEDURE

Participants assigned to this arm will undergo a sham procedure designed to mimic the experimental intervention. The procedure includes the same positioning, ultrasound guidance, needle insertion, and duration as the experimental arm; however, no electrical current will be delivered. Blood samples will be collected at the same pre- and post-procedure time points as in the experimental arm. This control condition is used to account for nonspecific effects related to needling and the procedural context. \-

Sham control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. Male participants aged 18 to 48 years. 2. Presence of low back pain at the time of enrollment. 3. Identification of the lumbar multifidus muscle as a target for the intervention.
• \. Good general health status, as determined by medical history. 5. Physically active or athletic individuals. 6. Non-smokers. 7. Ability and willingness to comply with study procedures. 8. Provision of written informed consent prior to participation.

You may not qualify if:

• \. History of spinal surgery or significant spinal trauma. 2. Presence of neurological disorders affecting the lumbar spine or lower limbs.
• \. Known systemic inflammatory, metabolic, or autoimmune diseases. 4. Use of anti-inflammatory, analgesic, or corticosteroid medication within a predefined period prior to enrollment.
• \. Coagulation disorders or current use of anticoagulant therapy. 6. Active infection, skin lesion, or dermatological condition at the intervention site.
• \. Contraindications to invasive physiotherapy or needle-based procedures. 8. Participation in another interventional clinical study within the previous months.
• \. Inability to tolerate blood sampling procedures.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Piamonte University

Vercelli, Italy

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to group allocation. Blood samples are coded and analyzed in a blinded manner. The intervention provider is not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 21, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-02

Locations

IT (1)