Low Back Pain
Conditions
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.
Interventions
PROCEDUREPercutaneous 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.
PROCEDURESham
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. \-
Sponsors
Universidad Europea de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are blinded to group allocation. Blood samples are coded and analyzed in a blinded manner. The intervention provider is not blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood proteomic profile | Baseline (pre-intervention) , post-intervention (20min after the intervention) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expressed blood lipidomic | Baseline (pre-intervention) , post-intervention (20min after the intervention) | 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. |
| Pain perception | Baseline (pre-intervention) , post-intervention (20min after the intervention) | 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. |
Countries
Italy
Outcome results
None listed