Multi-Omics Characterization of Percutaneous Electrolysis in Low Back Pain (MOPE-LBP)

Dentification of the Biochemical and Molecular Effects of Percutaneous Electrolysis on the Lumbar Multifidus Muscle in Patients With Low Back Pain Through a Blood-Based Multi-Omics Approach

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Sham; Procedure: Percutaneous electrolysis

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Vercelli, Italy
    • Piamonte University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- 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.

4. 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.

Exclusion Criteria:

• 1. History of spinal surgery or significant spinal trauma. 2. Presence of neurological disorders affecting the lumbar spine or lower limbs.

  3. Known systemic inflammatory, metabolic, or autoimmune diseases. 4. Use of anti-inflammatory, analgesic, or corticosteroid medication within a predefined period prior to enrollment.

  5. Coagulation disorders or current use of anticoagulant therapy. 6. Active infection, skin lesion, or dermatological condition at the intervention site.

  7. Contraindications to invasive physiotherapy or needle-based procedures. 8. Participation in another interventional clinical study within the previous months.

  9. Inability to tolerate blood sampling procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham control; 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; 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. -
Experimental: Percutaneous electrolysis; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expressed blood lipidomic	The Blood Lipidomic Profile is measured by collecting blood samples at two time points: pre-intervention (T1) and post-intervention (T2). Plasma lipids are extracted using a biphasic method and analyzed by liquid chromatography coupled with mass spectrometry (UHPLC-Orbitrap). The lipidomic analysis involves a detailed quantification of lipid species, including the measurement of lipid classes and their associated metabolites. Data are processed using MS-DIAL for peak detection and alignment, followed by normalization with internal standards. The relative concentrations of lipids are compared between pre- and post-treatment samples to identify significant changes in lipid profiles associated with the intervention.	Baseline (pre-intervention) , post-intervention (20min after the intervention)
Pain perception	Pain perception is measured using the Visual Analog Scale (VAS). Participants are asked to rate their pain intensity on a 10 cm line, where 0 cm represents "no pain" and 10 cm represents "worst pain imaginable." The VAS is administered at two key time points: pre-intervention (T1) and post-intervention (T2). The change in pain intensity between the pre- and post-treatment measurements is assessed to evaluate the effect of the intervention on pain perception.	Baseline (pre-intervention) , post-intervention (20min after the intervention)

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 21, 2026

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain; salicylhydroxamic acid
• Other Study ID Numbers: C.I. 24/763-EC_P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No