Chronic Low-back PainNCT04290221

Effectiveness Analysis of Ultrasound-guided Intratissue Percutaneous Electrolysis (EPI) in Patient With Chronic Low Back Pain

A study testing Ultrasound-guided percutaneous electrolysis in the lumbar nerve root and Electrical Dry Needling in trigger points in people with Chronic Low-back Pain, run by Universidad de Almeria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The main objective of this study is to analyze the effectiveness of the lumbar nerve root stimulation with ultrasound-guided percutaneous electrolysis versus the electrical dry needling of trigger points in patients with chronic low back pain. Read more about this study

Who is it for?: Ages 30 to 67 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Low-back Pain
What is being tested?: Ultrasound-guided percutaneous electrolysis in the lumbar nerve root and Electrical Dry Needling in trigger points
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteSpain
Study dates: 30 Nov 2021to 4 Jun 2023
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 30 to 67 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Low back pain ≥ 3 months.
Age between 30 and 67 years old.
Score ≥ 4 points on the Roland Morris Disability Questionnaire.
Not being receiving other physical therapy.

Who cannot join

Presence of lumbar stenosis.
Diagnosis of spondylolisthesis.
Diagnosis of fibromyalgia.
Treatment with corticosteroids or oral medication in recent weeks.
History of spine surgery.
Contraindication of analgesic electrical therapy.
Have previously received a treatment of intratissue percutaneous electrolysis.
Central or peripheral nervous system disease.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universidad de Almeria
Almería, Almeria, 04120

Other trials in Spain

About this study

Official title: Comparing Effectiveness Two Intratissue Percutaneous Electrolysis (EPI) Interventions for Chronic Low Back Pain: Lumbar Nerve Root Stimulation vs Trigger Points Stimulation

Read the detailed description

Given that recently the effectiveness of intratissue percutaneous electrolysis (EPI) has become of interest in the treatment of chronic musculoskeletal pain, when conventional physiotherapy management is not successful, the EPI can promote the healing biological processes. Several studies have demonstrated that inflammation can play an important role in the progression of muscle degeneration, in addition to potentially contributing to painful symptoms in individuals with chronic low back pain.

This technique involves nonthermal, electrochemical ablation of the lesion via the use of a cathodic fluid. The inflammation provoked is very localized and healing is rapid. Although EPI has been widely employed lately, the literature contains few studies validating its use.

The good results reported in studies of tendinopathies have to the undertaking of the present work, which compares the long-term effectiveness of EPI and dry needling-both ultrasound-guided-for the treatment of chronic low back pain.

A double blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients of experimental group will receive 1 weekly sessions of intratissue percutaneous electrolysis for 3 weeks, for a total of 3 sessions. The aim is to compare the effectiveness of applying percutaneous electrolysis in the lumbar nerve root versus applying electrical dry needling on trigger points of the gluteus medius, quadratus lumborum, and erector spinae muscles (6 sessions, once a week) on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility and muscular electrical activity.

Conditions: Chronic Low-back Pain
Being tested: Ultrasound-guided percutaneous electrolysis in the lumbar nerve root, Electrical Dry Needling in trigger points
Keywords: Intratissue Percutaneous Electrolysis, Trigger points, Lumbar nerve root, Randomized clinical trial, Electrical dry needling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ultrasound-guided percutaneous electrolysis in the lumbar nerve rootOther
This group will be treated with intratissue percutaneous electrolysis using a needle G32 with galvanic current as a cathodic flow electrode in the posterior nerve root of L3 (one times per week / 6 weeks). The intervention will be guided by ultrasound equipment medically certified (Directive 93/42 / EEC) device (EPI Advanced Medicine, Barcelona, Spain).
Electrical Dry Needling in trigger pointsOther
It consists in apply the ultrasound-guided percutaneous electrolysis on active and/or latent TPs in the gluteus medius, quadratus lumborum, and erector spinae muscles of the subjects L3 (one times per week / 6 weeks).

Study groups in NCT04290221
Study group	Role	What they receive
Percutaneous electrolysis in the lumbar nerv	Experimental	This group will be treated with intratissue percutaneous electrolysis using a needle G32 with galvanic current as a cathodic flow electrode in the posterior nerve root of L3, L4 and L5, bilaterally (one times per week / 6 weeks). The intervention will be guided by ultrasound equipment medically certified (Directive 93/42 / EEC) device (EPI Advanced Medicine, Barcelona, Spain). Receives: Other: Ultrasound-guided percutaneous electrolysis in the lumbar nerve root
Electrical dry needling in trigger points	Active comparator	It consists in apply the electrical dry needling on active and/or latent TPs in the gluteus medius, quadratus lumborum, and erector spinae muscles of the subjects L3 (one times per week / 6 weeks). Receives: Other: Electrical Dry Needling in trigger points

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in Algometry
An instrument for measuring the degree of sensitivity to pain. We will carry out a location of the myofascial trigger points following the illustrations of location of the myofascial trigger points that indicate Travell and Simons of both the left and right hemibody.
Once located they will be classified as active or latent. Measured in kg / cm 2 with an analog pressure algometer model Wagner FDK20. To carry out this diagnosis using the analog pressure algometer, a force of 1Kg / sec will be applied until the subject indicates with a "YA" presence of pain, at that time we will stop the pressure made with the analog pressure algometer and record the result. The measurement will be executed 3 times with a 30 sec rest between each measurement and an average of the 3 results obtained will be obtained.
Myofascial trigger points that do not meet the above criteria will be considered latent and which will not be subject to any treatment.
Measured: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.
Measured: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.

Secondary outcomes (9)

Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
It has 10 items associated to activities of daily living, each item has a punctuation from 0 to 5 points.
Measured: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in pain intensity. Visual analogue scale.
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain
Measured: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
Is a 17-item questionnaire that measures the fear of movement and (re)injury.
Measured: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline on Quality of Life. SF-36 Health questionnaire.
SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
Measured: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from Mcquade Test.
It measures the isometric endurance of trunk flexion muscles.
Measured: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in range of motion and lumbar segmental mobility
This variable is quantified using the SpinalMouse ® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagittal spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way.
Measured: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in Fingers-floor distance (cm)
The patient flexes the trunk forward from the standing position, and the distance from the fingers to the ground is measured.
Measured: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in Quality of Sleep . Pittsburgh Quality of Sleep Questionnaire Index
The Pittsburgh Quality of Sleep Questionnaire Index (PSQI) will be used to study the quality of sleep. It comprises 24 items where the subjects respond to 19 of these items, and individual living in the same dwelling (or hospital room) responds to the remaining 5. Scores are obtained on each of 7 components of sleep quality: subjective quality, sleep latency, sleep duration, habitual sleep efficacy, sleep perturbations, use of hypnotic medication, and daily dysfunction.
Measured: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in Anxiety. Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-question instrument that measures anxiety and depression. Each question is scored between 0 (no impairment) and 3 (severe impairment), with a maximum score of 21 for anxiety or depression.
Measured: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 20214 Jun 2023

First posted28 Feb 2020
Study start30 Nov 2021
Primary completion4 Mar 2022
Study completion4 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Chronic 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: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04290221
Sponsor's protocol ID: UALBIO2019/037
Status last verified: Sep 2023
First submitted: 26 Feb 2020
Last updated: 5 Feb 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

de Miguel Valtierra L, Salom Moreno J, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria JL. Ultrasound-Guided Application of Percutaneous Electrolysis as an Adjunct to Exercise and Manual Therapy for Subacromial Pain Syndrome: A Randomized Clinical Trial. J Pain. 2018 Oct;19(10):1201-1210. doi: 10.1016/j.jpain.2018.04.017. Epub 2018 May 16.
PubMed 29777953
Freeman MD, Woodham MA, Woodham AW. The role of the lumbar multifidus in chronic low back pain: a review. PM R. 2010 Feb;2(2):142-6; quiz 1 p following 167. doi: 10.1016/j.pmrj.2009.11.006.
PubMed 20193941
Shahidi B, Hubbard JC, Gibbons MC, Ruoss S, Zlomislic V, Allen RT, Garfin SR, Ward SR. Lumbar multifidus muscle degenerates in individuals with chronic degenerative lumbar spine pathology. J Orthop Res. 2017 Dec;35(12):2700-2706. doi: 10.1002/jor.23597. Epub 2017 May 23.
PubMed 28480978
Shahidi B, Parra CL, Berry DB, Hubbard JC, Gombatto S, Zlomislic V, Allen RT, Hughes-Austin J, Garfin S, Ward SR. Contribution of Lumbar Spine Pathology and Age to Paraspinal Muscle Size and Fatty Infiltration. Spine (Phila Pa 1976). 2017 Apr 15;42(8):616-623. doi: 10.1097/BRS.0000000000001848.
PubMed 27517512
Abat F, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibanez JM. Clinical results after ultrasound-guided intratissue percutaneous electrolysis (EPI(R)) and eccentric exercise in the treatment of patellar tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2015 Apr;23(4):1046-52. doi: 10.1007/s00167-014-2855-2. Epub 2014 Jan 30.
PubMed 24477495
Tuzun EH, Gildir S, Angin E, Tecer BH, Dana KO, Malkoc M. Effectiveness of dry needling versus a classical physiotherapy program in patients with chronic low-back pain: a single-blind, randomized, controlled trial. J Phys Ther Sci. 2017 Sep;29(9):1502-1509. doi: 10.1589/jpts.29.1502. Epub 2017 Sep 15.
PubMed 28931976
Iborra-Marcos A, Ramos-Alvarez JJ, Rodriguez-Fabian G, Del Castillo-Gonzalez F, Lopez-Roman A, Polo-Portes C, Villanueva-Martinez M. Intratissue Percutaneous Electrolysis vs Corticosteroid Infiltration for the Treatment of Plantar Fasciosis. Foot Ankle Int. 2018 Jun;39(6):704-711. doi: 10.1177/1071100718754421. Epub 2018 Feb 13.
PubMed 29436233
Jensen TS, Karppinen J, Sorensen JS, Niinimaki J, Leboeuf-Yde C. Vertebral endplate signal changes (Modic change): a systematic literature review of prevalence and association with non-specific low back pain. Eur Spine J. 2008 Nov;17(11):1407-22. doi: 10.1007/s00586-008-0770-2. Epub 2008 Sep 12.
PubMed 18787845
Shahidi B, Fisch KM, Gibbons MC, Ward SR. Increased Fibrogenic Gene Expression in Multifidus Muscles of Patients With Chronic Versus Acute Lumbar Spine Pathology. Spine (Phila Pa 1976). 2020 Feb 15;45(4):E189-E195. doi: 10.1097/BRS.0000000000003243.
PubMed 31513095
Goubert D, Oosterwijck JV, Meeus M, Danneels L. Structural Changes of Lumbar Muscles in Non-specific Low Back Pain: A Systematic Review. Pain Physician. 2016 Sep-Oct;19(7):E985-E1000.
PubMed 27676689
Arias-Buria JL, Truyols-Dominguez S, Valero-Alcaide R, Salom-Moreno J, Atin-Arratibel MA, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:315219. doi: 10.1155/2015/315219. Epub 2015 Nov 15.
PubMed 26649058
Valera-Garrido F, Minaya-Munoz F, Medina-Mirapeix F. Ultrasound-guided percutaneous needle electrolysis in chronic lateral epicondylitis: short-term and long-term results. Acupunct Med. 2014 Dec;32(6):446-54. doi: 10.1136/acupmed-2014-010619. Epub 2014 Aug 13.
PubMed 25122629

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Chronic Low-back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing Effectiveness Two Intratissue Percutaneous Electrolysis (EPI) Interventions for Chronic Low Back Pain: Lumbar Nerve Root Stimulation vs Trigger Points Stimulation
ClinicalTrials.gov ID: NCT04290221
Acronym / sponsor ID: UALBIO2019/037
Conditions: Chronic Low-back Pain
Keywords: Intratissue Percutaneous Electrolysis, Trigger points, Lumbar nerve root, Randomized clinical trial, Electrical dry needling
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Universidad de AlmeriaUniversity, hospital or other
Study start: 30 Nov 2021 (actual)
Primary completion: 4 Mar 2022 (actual)
Study completion: 4 Jun 2023 (actual)
First posted: 28 Feb 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Percutaneous electrolysis in the lumbar nerv	Experimental	Other: Ultrasound-guided percutaneous electrolysis in the lumbar nerve rootThis group will be treated with intratissue percutaneous electrolysis using a needle G32 with galvanic current as a cathodic flow electrode in the posterior nerve root of L3, L4 and L5, bilaterally (one times per week / 6 weeks). The intervention will be guided by ultrasound equipment medically certified (Directive 93/42 / EEC) device (EPI Advanced Medicine, Barcelona, Spain).
Electrical dry needling in trigger points	Active comparator	Other: Electrical Dry Needling in trigger pointsIt consists in apply the electrical dry needling on active and/or latent TPs in the gluteus medius, quadratus lumborum, and erector spinae muscles of the subjects L3 (one times per week / 6 weeks).

Who may qualify

Ages: 30 to 67 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Low back pain ≥ 3 months.
Age between 30 and 67 years old.
Score ≥ 4 points on the Roland Morris Disability Questionnaire.
Not being receiving other physical therapy.

Key exclusion criteria (8 listed)

Presence of lumbar stenosis.
Diagnosis of spondylolisthesis.
Diagnosis of fibromyalgia.
Treatment with corticosteroids or oral medication in recent weeks.
History of spine surgery.

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
Ultrasound-guided percutaneous electrolysis in the lumbar nerve rootThis group will be treated with intratissue percutaneous electrolysis using a needle G32 with galvanic current as a cathodic flow electrode in the posterior nerve root of L3 (one times per week / 6 weeks). The intervention will be guided by ultrasound equipment medically certified (Directive 93/42 / EEC) device (EPI Advanced Medicine, Barcelona, Spain).	Other	Percutaneous electrolysis in the lumbar nerv
Electrical Dry Needling in trigger pointsIt consists in apply the ultrasound-guided percutaneous electrolysis on active and/or latent TPs in the gluteus medius, quadratus lumborum, and erector spinae muscles of the subjects L3 (one times per week / 6 weeks).	Other	Electrical dry needling in trigger points

Primary outcome

Change from baseline in Algometry
Time frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
An instrument for measuring the degree of sensitivity to pain. We will carry out a location of the myofascial trigger points following the illustrations of location of the myofascial trigger points that indicate Travell and Simons of both the left and right hemibody. Once located they will be classified as active or latent. Measured in kg / cm 2 with an analog pressure algometer model Wagner FDK20. To carry out this diagnosis using the analog pressure algometer, a force of 1Kg / sec will be applied until the subject indicates with a "YA" presence of pain, at that time we will stop the pressure made with the analog pressure algometer and record the result. The measurement will be executed 3 times with a 30 sec rest between each measurement and an average of the 3 results obtained will be obtained. Myofascial trigger points that do not meet the above criteria will be considered latent and which will not be subject to any treatment.
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
Time frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.

9 secondary outcomes

Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
Time frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in pain intensity. Visual analogue scale.
Time frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
Time frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline on Quality of Life. SF-36 Health questionnaire.
Time frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from Mcquade Test.
Time frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in range of motion and lumbar segmental mobility
Time frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in Fingers-floor distance (cm)
Time frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in Quality of Sleep . Pittsburgh Quality of Sleep Questionnaire Index
Time frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.
Change from baseline in Anxiety. Hospital Anxiety and Depression Scale (HADS)
Time frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last 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 5 Feb 2025.
Background: PubMed 29777953de Miguel Valtierra L, Salom Moreno J, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria JL. Ultrasound-Guided Application of Percutaneous Electrolysis as an Adjunct to Exercise and Manual Therapy for Subacromial Pain Syndrome: A Randomized Clinical Trial. J Pain. 2018 Oct;19(10):1201-1210. doi: 10.1016/j.jpain.2018.04.017. Epub 2018 May 16.
Background: PubMed 20193941Freeman MD, Woodham MA, Woodham AW. The role of the lumbar multifidus in chronic low back pain: a review. PM R. 2010 Feb;2(2):142-6; quiz 1 p following 167. doi: 10.1016/j.pmrj.2009.11.006.
Background: PubMed 28480978Shahidi B, Hubbard JC, Gibbons MC, Ruoss S, Zlomislic V, Allen RT, Garfin SR, Ward SR. Lumbar multifidus muscle degenerates in individuals with chronic degenerative lumbar spine pathology. J Orthop Res. 2017 Dec;35(12):2700-2706. doi: 10.1002/jor.23597. Epub 2017 May 23.
Background: PubMed 27517512Shahidi B, Parra CL, Berry DB, Hubbard JC, Gombatto S, Zlomislic V, Allen RT, Hughes-Austin J, Garfin S, Ward SR. Contribution of Lumbar Spine Pathology and Age to Paraspinal Muscle Size and Fatty Infiltration. Spine (Phila Pa 1976). 2017 Apr 15;42(8):616-623. doi: 10.1097/BRS.0000000000001848.
Background: PubMed 24477495Abat F, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibanez JM. Clinical results after ultrasound-guided intratissue percutaneous electrolysis (EPI(R)) and eccentric exercise in the treatment of patellar tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2015 Apr;23(4):1046-52. doi: 10.1007/s00167-014-2855-2. Epub 2014 Jan 30.
Background: PubMed 28931976Tuzun EH, Gildir S, Angin E, Tecer BH, Dana KO, Malkoc M. Effectiveness of dry needling versus a classical physiotherapy program in patients with chronic low-back pain: a single-blind, randomized, controlled trial. J Phys Ther Sci. 2017 Sep;29(9):1502-1509. doi: 10.1589/jpts.29.1502. Epub 2017 Sep 15.
Background: PubMed 29436233Iborra-Marcos A, Ramos-Alvarez JJ, Rodriguez-Fabian G, Del Castillo-Gonzalez F, Lopez-Roman A, Polo-Portes C, Villanueva-Martinez M. Intratissue Percutaneous Electrolysis vs Corticosteroid Infiltration for the Treatment of Plantar Fasciosis. Foot Ankle Int. 2018 Jun;39(6):704-711. doi: 10.1177/1071100718754421. Epub 2018 Feb 13.
Background: PubMed 18787845Jensen TS, Karppinen J, Sorensen JS, Niinimaki J, Leboeuf-Yde C. Vertebral endplate signal changes (Modic change): a systematic literature review of prevalence and association with non-specific low back pain. Eur Spine J. 2008 Nov;17(11):1407-22. doi: 10.1007/s00586-008-0770-2. Epub 2008 Sep 12.
Background: PubMed 31513095Shahidi B, Fisch KM, Gibbons MC, Ward SR. Increased Fibrogenic Gene Expression in Multifidus Muscles of Patients With Chronic Versus Acute Lumbar Spine Pathology. Spine (Phila Pa 1976). 2020 Feb 15;45(4):E189-E195. doi: 10.1097/BRS.0000000000003243.
Background: PubMed 27676689Goubert D, Oosterwijck JV, Meeus M, Danneels L. Structural Changes of Lumbar Muscles in Non-specific Low Back Pain: A Systematic Review. Pain Physician. 2016 Sep-Oct;19(7):E985-E1000.
Background: PubMed 26649058Arias-Buria JL, Truyols-Dominguez S, Valero-Alcaide R, Salom-Moreno J, Atin-Arratibel MA, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:315219. doi: 10.1155/2015/315219. Epub 2015 Nov 15.
Background: PubMed 25122629Valera-Garrido F, Minaya-Munoz F, Medina-Mirapeix F. Ultrasound-guided percutaneous needle electrolysis in chronic lateral epicondylitis: short-term and long-term results. Acupunct Med. 2014 Dec;32(6):446-54. doi: 10.1136/acupmed-2014-010619. Epub 2014 Aug 13.

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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?

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 4 inclusion and 8 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 5 Feb 2025. 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?

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?

Change from baseline in Algometry (time frame: At baseline, at 3 weeks, at 6 weeks, and 1 month after the last intervention.). The study lists 2 primary outcomes in all. 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 NCT04290221, which also lists 12 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 5 Feb 2025.