Low Back PainElectrolysisNCT06661070
Electrolysis in Patients With Low Back Pain
A study testing Electrolysis Percutaneous Therapeutic (EPTE) and Dry Needling in people with Low Back Pain, run by Wroclaw University of Health and Sport Sciences at 1 site in Spain.
Trial summary
The goal of this observational study is to investigate the efficacy of percutaneous electrolysis compared with dry needling on pain sensations and multifidus muscle properties in subjects with low back pain. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Electrolysis Percutaneous Therapeutic (EPTE) and Dry Needling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 4 Nov 2024to 23 Nov 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- to report low back pain of at least six months duration,
- aged 35 to 50 years,
- at least one active trigger point is present in the multifidus muscle.
Who cannot join
- pharmacological (e.g., analgesics) or physiotherapy treatment before or during their participation in the study,
- needle fear,
- prior lower extremity or spine surgery, absence of pain, any musculoskeletal or neuropathic conditions (e.g., peripheral compressive neuropathy, radiculopathy, sarcopenia, fibromyalgia, muscle ruptures), traumatic injuries (e.g., fractures or fissures), or any medical condition or contraindication for needling treatment (e.g., anticoagulants).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Faculty of Nursery, Physiotherapy and Podiatry
Madrid, 28040
Juan Antonio Valera-Calero, PhD, +34913941524, juavaler@ucm.es
About this study
Official title: Short-term Effectiveness of High- and Low-intensity Percutaneous Electrolysis in Patients With Low Back Pain
The goal of this observational study is to investigate the efficacy of percutaneous electrolysis compared with dry needling on pain sensations and multifidus muscle properties in subjects with low back pain. The main questions it aims to answer are:
The high-intensity and low-intensity percutaneous electrolysis may induce pressure pain threshold (PPT) changes in myofascial trigger points in the low back during the intervention compared with dry needling.
Percutaneous electrolysis interventions may reduce stiffness in the multifidus muscle during the intervention compared with dry needling.
Read the detailed description
A parallel-group, controlled, triple-blinded, randomized pilot clinical trial comparing the effects of a single session of high-intensity percutaneous electrolysis (HIPE), low-intensity percutaneous electrolysis (LIPE), and dry needling (DN) applied to the multifidus muscle most active MTrP in subjects with low back pain. This clinical trial will follow the Consolidated Standards of Reporting Trials for pragmatic clinical trials.
This procedure consists of three trials, i.e., (1, HIPE) 660 uA x 30"; (2, LIPE) 220uA x 30"; and (3, DN) with 1 twitch response, and the needle inserted 30".
- Conditions
- Low Back Pain
- Being tested
- Electrolysis Percutaneous Therapeutic (EPTE), Dry Needling
- Keywords
- Low Back, Pain, Multifidus muscle, Trigger Points, shear-wave elastography, pain sensitivity
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrolysis Percutaneous Therapeutic (EPTE)Device
EPTE device (Ionclinics, Valencia, Spain)
Dry NeedlingOther
A dry needle with size 0.30 × 40 (Agupunt, Barcelona, Spain)
| Study group | Role | What they receive |
|---|---|---|
| High-intensity percutaneous electrolysis (HIPE) | Experimental | The HIPE group receives a 660 mA galvanic current for 10 s. Receives: Device: Electrolysis Percutaneous Therapeutic (EPTE) |
| Low-intensity percutaneous electrolysis (LIPE) | Experimental | The LIPE group receives a 220 mA × 30 s. Receives: Device: Electrolysis Percutaneous Therapeutic (EPTE) |
| Dry Needling (DN) | Active comparator | The DN group received no galvanic current. Receives: Other: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain changes in pain intensity before and after the intervention
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patient's current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area.
Measured: Baseline, immediately after, and 24 after of intervention
Secondary outcomes (2)
Pressure Pain Threshold
Somedic Algometer type 2 was used to measure PPT. The diameter of the contact tip was 10 mm and covered with 2 mm thick rubber. The pressure on point and its rate was standardized (30 kPa s-1 ). The value of the pain threshold equals the value of the pressure at which the examined person reported that the pressure exerted on a certain point causes pain.
Measured: Baseline, immediately after, and 24 after of intervention
Muscle stiffness
An ultrasound machine with shear-wave elastography Canon Aplio A device, using a linear transducer PLT-1005-BT (Canon Medical Corp, 1385 Shimoishigami, Otawara, Tochigi 324-8550, Japan). The console settings will also be standard for all the acquisitions (Frequency=11 MHz, Gain=78 dB, Dynamic Range=75, and Depth=4.5 cm).
Measured: Baseline, immediately after, and 24 after of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start4 Nov 2024 (estimated)
- Primary completion23 Nov 2024 (estimated)
- Study completion23 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Model description
- A triple-blinded, pilot randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Complutense de Madrid, Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, Sebastian Klich, Wroclaw University of Health and Sport Sciences
- Investigators
- Juan Antonio Valera-Calero, PhD, Study director, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661070
- Sponsor's protocol ID
- UCM#1
- Other IDs
- #19/044
- Acronym
- Electrolysis
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rozenfeld E, Finestone AS, Moran U, Damri E, Kalichman L. Test-retest reliability of myofascial trigger point detection in hip and thigh areas. J Bodyw Mov Ther. 2017 Oct;21(4):914-919. doi: 10.1016/j.jbmt.2017.03.023. Epub 2017 Mar 29.
PubMed 29037648Fernandez-de-Las-Penas C, Dommerholt J. International Consensus on Diagnostic Criteria and Clinical Considerations of Myofascial Trigger Points: A Delphi Study. Pain Med. 2018 Jan 1;19(1):142-150. doi: 10.1093/pm/pnx207.
PubMed 29025044Valera-Calero JA, Sanchez-Mayoral-Martin A, Varol U. Short-term effectiveness of high- and low-intensity percutaneous electrolysis in patients with patellofemoral pain syndrome: A pilot study. World J Orthop. 2021 Oct 18;12(10):781-790. doi: 10.5312/wjo.v12.i10.781. eCollection 2021 Oct 18.
PubMed 34754834
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effectiveness of High- and Low-intensity Percutaneous Electrolysis in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT06661070
- Acronym / sponsor ID
- Electrolysis / UCM#1
- Conditions
- Low Back Pain
- Keywords
- Low Back, Pain, Multifidus muscle, Trigger Points, shear-wave elastography, pain sensitivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Collaborators
- Universidad Complutense de Madrid, Universidad Rey Juan Carlos
- Study start
- 4 Nov 2024 (estimated)
- Primary completion
- 23 Nov 2024 (estimated)
- Study completion
- 23 Nov 2024 (estimated)
- First posted
- 28 Oct 2024 (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.
The goal of this observational study is to investigate the efficacy of percutaneous electrolysis compared with dry needling on pain sensations and multifidus muscle properties in subjects with low back pain. The main questions it aims to answer are:
The high-intensity and low-intensity percutaneous electrolysis may induce pressure pain threshold (PPT) changes in myofascial trigger points in the low back during the intervention compared with dry needling.
Percutaneous electrolysis interventions may reduce stiffness in the multifidus muscle during the intervention compared with dry needling.
Detailed description
A parallel-group, controlled, triple-blinded, randomized pilot clinical trial comparing the effects of a single session of high-intensity percutaneous electrolysis (HIPE), low-intensity percutaneous electrolysis (LIPE), and dry needling (DN) applied to the multifidus muscle most active MTrP in subjects with low back pain. This clinical trial will follow the Consolidated Standards of Reporting Trials for pragmatic clinical trials.
This procedure consists of three trials, i.e., (1, HIPE) 660 uA x 30"; (2, LIPE) 220uA x 30"; and (3, DN) with 1 twitch response, and the needle inserted 30".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A triple-blinded, pilot randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| High-intensity percutaneous electrolysis (HIPE) | Experimental | Device: Electrolysis Percutaneous Therapeutic (EPTE)The HIPE group receives a 660 mA galvanic current for 10 s. |
| Low-intensity percutaneous electrolysis (LIPE) | Experimental | Device: Electrolysis Percutaneous Therapeutic (EPTE)The LIPE group receives a 220 mA × 30 s. |
| Dry Needling (DN) | Active comparator | Other: Dry NeedlingThe DN group received no galvanic current. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- to report low back pain of at least six months duration,
- aged 35 to 50 years,
- at least one active trigger point is present in the multifidus muscle.
Key exclusion criteria (3 listed)
- pharmacological (e.g., analgesics) or physiotherapy treatment before or during their participation in the study,
- needle fear,
- prior lower extremity or spine surgery, absence of pain, any musculoskeletal or neuropathic conditions (e.g., peripheral compressive neuropathy, radiculopathy, sarcopenia, fibromyalgia, muscle ruptures), traumatic injuries (e.g., fractures or fissures), or any medical condition or contraindication for needling treatment (e.g., anticoagulants).
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 |
|---|---|---|
| Electrolysis Percutaneous Therapeutic (EPTE)EPTE device (Ionclinics, Valencia, Spain) | Device | High-intensity percutaneous electrolysis (HIPE), Low-intensity percutaneous electrolysis (LIPE) |
| Dry NeedlingA dry needle with size 0.30 × 40 (Agupunt, Barcelona, Spain) | Other | Dry Needling (DN) |
Primary outcome
Pain changes in pain intensity before and after the intervention
Time frame: Baseline, immediately after, and 24 after of intervention
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patient's current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area.
2 secondary outcomes
Pressure Pain Threshold
Time frame: Baseline, immediately after, and 24 after of intervention
Muscle stiffness
Time frame: Baseline, immediately after, and 24 after of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Results publication: PubMed 29037648Rozenfeld E, Finestone AS, Moran U, Damri E, Kalichman L. Test-retest reliability of myofascial trigger point detection in hip and thigh areas. J Bodyw Mov Ther. 2017 Oct;21(4):914-919. doi: 10.1016/j.jbmt.2017.03.023. Epub 2017 Mar 29.
- Results publication: PubMed 29025044Fernandez-de-Las-Penas C, Dommerholt J. International Consensus on Diagnostic Criteria and Clinical Considerations of Myofascial Trigger Points: A Delphi Study. Pain Med. 2018 Jan 1;19(1):142-150. doi: 10.1093/pm/pnx207.
- Results publication: PubMed 34754834Valera-Calero JA, Sanchez-Mayoral-Martin A, Varol U. Short-term effectiveness of high- and low-intensity percutaneous electrolysis in patients with patellofemoral pain syndrome: A pilot study. World J Orthop. 2021 Oct 18;12(10):781-790. doi: 10.5312/wjo.v12.i10.781. eCollection 2021 Oct 18.
- Individual participant dataSharing planned: No
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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.
Juan Antonio Valera-Calero, PhD study director
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrolysis Percutaneous Therapeutic (EPTE) and Dry Needling in people with Low Back Pain, run by Wroclaw University of Health and Sport Sciences at 1 site in Spain.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 28 Oct 2024. 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 Spain. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Klich, PhD, DSc (+48713473176, sebastian.klich@awf.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain changes in pain intensity before and after the intervention (time frame: Baseline, immediately after, and 24 after of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06661070, which also lists 3 linked publications.
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 28 Oct 2024; AzTrials last refreshed its copy on 1 Nov 2026.