Multi-Omics Characterization of Percutaneous Electrolysis in Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Percutaneous electrolysis, Sham.
- Who it may be relevant to
- Registry conditions: Low Back Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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 interva - 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 co
Primary outcome measures
- Blood proteomic profile [Time frame: Baseline (pre-intervention) , post-intervention (20min after the intervention)]
Secondary outcome measures (2)
- Expressed blood lipidomic [Time frame: Baseline (pre-intervention) , post-intervention (20min after the intervention)]
- Pain perception [Time frame: Baseline (pre-intervention) , post-intervention (20min after the intervention)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Piamonte University — Vercelli
Identifiers
NCT: NCT07524010 · C.I. 24/763-EC_P