Low Back PainMOPE-LBPNCT07524010
Multi-Omics Characterization of Percutaneous Electrolysis in Low Back Pain
A study testing Percutaneous electrolysis in people with Low Back Pain, run by Universidad Europea de Madrid at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Percutaneous electrolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 20 May 2026to 21 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Percutaneous electrolysis, Sham
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous electrolysisProcedure or surgery
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.
ShamProcedure or surgery
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.
-
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Percutaneous electrolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-intervention) , post-intervention (20min after the intervention)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (pre-intervention) , post-intervention (20min after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start20 May 2026
- Primary completion20 Jun 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Romero Morales, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524010
- Sponsor's protocol ID
- C.I. 24/763-EC_P
- Acronym
- MOPE-LBP
- Status last verified
- Oct 2026
- First submitted
- 9 Feb 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07524010
- Acronym / sponsor ID
- MOPE-LBP / C.I. 24/763-EC_P
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham control | Sham comparator | Procedure: ShamParticipants 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. |
| Percutaneous electrolysis | Experimental | Procedure: Percutaneous electrolysisParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous electrolysisParticipants 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 or surgery | Percutaneous electrolysis |
| ShamParticipants 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 or surgery | Sham control |
Primary outcome
Blood proteomic profile
Time frame: 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.
2 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous electrolysis in people with Low Back Pain, run by Universidad Europea de Madrid at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood proteomic profile (time frame: Baseline (pre-intervention) , post-intervention (20min after the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.