PainNCT04710992
Influence of Percutaneous Electrolysis on Endogenous Pain Modulation
A study testing Isolated needling procedure, Low intensity percutaneous electrolysis and High intensity percutaneous electrolysis in people with Pain, run by University of Salamanca at 1 site in Spain.
Trial summary
Percutaneous electrolysis is a minimally invasive approach that consists in the application of a galvanic current through an acupuncture needle. Although several mechanisms and effects are attributed to percutaneous electrolysis, currently there are only a few publications that delve into this topic. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Isolated needling procedure, Low intensity percutaneous electrolysis and High intensity percutaneous electrolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 3 Oct 2022to 23 Dec 2022
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy asymptomatic subjects
- Aged 18 to 40 years
- Both genders
Who cannot join
- Belonephobia or fear of needles
- Neurological, cardiovascular or metabolic diseases
- Any pathology or process that causes pain
- Cutaneous alterations
- Pregnancy
- Cognitive and sensitivity disorders
Show all 11Show fewer
- Fibromyalgia
- Frequent or recent (24 hours before) intake of alcohol and other drugs
- Have received pharmacological, physiotherapeutic or other treatment in the last week
- Intake of caffeine in the two hours prior to measurement
- Vigorous physical activity on the day of testing
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad de Enfermería y Fisioterapia de la Universidad de Salamanca
Salamanca, 37007
About this study
Official title: Influence of Percutaneous Electrolysis on Endogenous Pain Modulation: A Randomized Clinical Trial
Percutaneous electrolysis is a minimally invasive approach that consists in the application of a galvanic current through an acupuncture needle. Although several mechanisms and effects are attributed to percutaneous electrolysis, currently there are only a few publications that delve into this topic. The aim of this study is to investigate the influence of percutaneous electrolysis on the endogenous pain modulation. Four groups of intervention will be involved: no-intervention, isolated needling procedure, low intensity percutaneous electrolysis and high intensity percutaneous electrolysis. The effects on the pain modulation system will be evaluated before and immediately after the intervention, through pressure pain thresholds, conditioned pain modulation and temporal summation.
- Conditions
- Pain
- Being tested
- Isolated needling procedure, Low intensity percutaneous electrolysis, High intensity percutaneous electrolysis
- Keywords
- Electric Stimulation Therapy, Randomized Clinical Trial, Interventional Ultrasonography, Percutaneous Electrolysis, Endogenous Pain Modulation, Pain, Conditioned Pain Modulation, Sensory Thresholds
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated needling procedureProcedure or surgery
The needle will be inserted into the common extensor tendon of the epicondyle (dominant elbow) for 90 seconds without galvanic current.
Low intensity percutaneous electrolysisProcedure or surgery
Once the needle is located in the common extensor tendon of the epicondyle (dominant elbow), a single impact of galvanic current will be applied with an intensity of 0.3 mA for 90 seconds.
High intensity percutaneous electrolysisProcedure or surgery
The needle will be inserted in the target position during the same time as in the other groups (90 seconds). During the first stage of intervention the needle will be imbedded without galvanic current and when the end of the application time approaches (approximately 75 seconds) three impacts of galvanic current will be applied with an intensity of 3 mA and a duration of 3 seconds each.
| Study group | Role | What they receive |
|---|---|---|
| Needling Group | Sham comparator | The needle will be inserted for 90 seconds without galvanic current. Receives: Procedure: Isolated needling procedure |
| Low intensity percutaneous electrolysis | Experimental | A single impact of galvanic current will be applied with an intensity of 0.3 mA for 90 seconds. Receives: Procedure: Low intensity percutaneous electrolysis |
| High intensity percutaneous electrolysis | Experimental | Three impacts of galvanic current will be applied with an intensity of 3 mA and a duration of 3 seconds each. Receives: Procedure: High intensity percutaneous electrolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Conditioned Pain Modulation (evaluated by pressure algometry) immediately after the intervention
Assessed by algometry. Conditioning stimulus: pressure cuff on the arm. Measured at three locations (bilaterally): common extensor tendon of the epicondyle, cervical spine and tibialis anterior muscle.
Measured: Baseline and immediately after the intervention
Secondary outcomes (2)
Change from baseline Pressure Pain Thresholds immediately after the intervention
Assessed by algometry. Measured at three locations (bilaterally): common extensor tendon of the epicondyle, cervical spine and tibialis anterior muscle.
Measured: Baseline and immediately after the intervention
Change from baseline Temporal Summation (evaluated by VNRS) immediately after the intervention
Assessed by Verbal Numeric Rating Scale (11-point). Temporary stimuli: 10 consecutive pressures with the algometer at the intensity of the pressure pain threshold. Three locations (bilaterally): common extensor tendon of the epicondyle, cervical spine and tibialis anterior muscle.
Measured: Baseline and immediately 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 posted15 Jan 2021
- Study start3 Oct 2022
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Varela Rodríguez, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710992
- Sponsor's protocol ID
- Electrolysis550
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2021
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Garcia Bermejo P, De La Cruz Torres B, Naranjo Orellana J, Albornoz Cabello M. Autonomic Responses to Ultrasound-Guided Percutaneous Needle Electrolysis: Effect of Needle Puncture or Electrical Current? J Altern Complement Med. 2018 Jan;24(1):69-75. doi: 10.1089/acm.2016.0339. Epub 2017 Jan 30.
PubMed 28135129Valera-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 25122629Abat F, Diesel WJ, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibanez JM. Effectiveness of the Intratissue Percutaneous Electrolysis (EPI(R)) technique and isoinertial eccentric exercise in the treatment of patellar tendinopathy at two years follow-up. Muscles Ligaments Tendons J. 2014 Jul 14;4(2):188-93. eCollection 2014 Apr.
PubMed 25332934Nir RR, Yarnitsky D. Conditioned pain modulation. Curr Opin Support Palliat Care. 2015 Jun;9(2):131-7. doi: 10.1097/SPC.0000000000000126.
PubMed 25699686Fernandez-de-Las-Penas C, Nijs J. Trigger point dry needling for the treatment of myofascial pain syndrome: current perspectives within a pain neuroscience paradigm. J Pain Res. 2019 Jun 18;12:1899-1911. doi: 10.2147/JPR.S154728. eCollection 2019.
PubMed 31354339Damien J, Colloca L, Bellei-Rodriguez CE, Marchand S. Pain Modulation: From Conditioned Pain Modulation to Placebo and Nocebo Effects in Experimental and Clinical Pain. Int Rev Neurobiol. 2018;139:255-296. doi: 10.1016/bs.irn.2018.07.024. Epub 2018 Aug 14.
PubMed 30146050Sanchez-Gonzalez JL, Navarro-Lopez V, Calderon-Diez L, Varela-Rodriguez S, Fernandez-de-Las-Penas C, Sanchez-Sanchez JL. Effectiveness of different percutaneous electrolysis protocols in the endogenous modulation of pain: A Double-Blinded Randomized Clinical Trial. Musculoskelet Sci Pract. 2023 Nov;68:102872. doi: 10.1016/j.msksp.2023.102872. Epub 2023 Oct 11.
PubMed 37847947
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Percutaneous Electrolysis on Endogenous Pain Modulation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04710992
- Acronym / sponsor ID
- Electrolysis550
- Conditions
- Pain
- Keywords
- Electric Stimulation Therapy, Randomized Clinical Trial, Interventional Ultrasonography, Percutaneous Electrolysis, Endogenous Pain Modulation, Pain, Conditioned Pain Modulation, Sensory Thresholds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 15 Jan 2021 (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.
Percutaneous electrolysis is a minimally invasive approach that consists in the application of a galvanic current through an acupuncture needle. Although several mechanisms and effects are attributed to percutaneous electrolysis, currently there are only a few publications that delve into this topic. The aim of this study is to investigate the influence of percutaneous electrolysis on the endogenous pain modulation. Four groups of intervention will be involved: no-intervention, isolated needling procedure, low intensity percutaneous electrolysis and high intensity percutaneous electrolysis. The effects on the pain modulation system will be evaluated before and immediately after the intervention, through pressure pain thresholds, conditioned pain modulation and temporal summation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Needling Group | Sham comparator | Procedure: Isolated needling procedureThe needle will be inserted for 90 seconds without galvanic current. |
| Low intensity percutaneous electrolysis | Experimental | Procedure: Low intensity percutaneous electrolysisA single impact of galvanic current will be applied with an intensity of 0.3 mA for 90 seconds. |
| High intensity percutaneous electrolysis | Experimental | Procedure: High intensity percutaneous electrolysisThree impacts of galvanic current will be applied with an intensity of 3 mA and a duration of 3 seconds each. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy asymptomatic subjects
- Aged 18 to 40 years
- Both genders
Key exclusion criteria (11 listed)
- Belonephobia or fear of needles
- Neurological, cardiovascular or metabolic diseases
- Any pathology or process that causes pain
- Cutaneous alterations
- Pregnancy
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 |
|---|---|---|
| Isolated needling procedureThe needle will be inserted into the common extensor tendon of the epicondyle (dominant elbow) for 90 seconds without galvanic current. | Procedure or surgery | Needling Group |
| Low intensity percutaneous electrolysisOnce the needle is located in the common extensor tendon of the epicondyle (dominant elbow), a single impact of galvanic current will be applied with an intensity of 0.3 mA for 90 seconds. | Procedure or surgery | Low intensity percutaneous electrolysis |
| High intensity percutaneous electrolysisThe needle will be inserted in the target position during the same time as in the other groups (90 seconds). During the first stage of intervention the needle will be imbedded without galvanic current and when the end of the application time approaches (approximately 75 seconds) three impacts of galvanic current will be applied with an intensity of 3 mA and a duration of 3 seconds each. | Procedure or surgery | High intensity percutaneous electrolysis |
Primary outcome
Change from baseline Conditioned Pain Modulation (evaluated by pressure algometry) immediately after the intervention
Time frame: Baseline and immediately after the intervention
Assessed by algometry. Conditioning stimulus: pressure cuff on the arm. Measured at three locations (bilaterally): common extensor tendon of the epicondyle, cervical spine and tibialis anterior muscle.
2 secondary outcomes
Change from baseline Pressure Pain Thresholds immediately after the intervention
Time frame: Baseline and immediately after the intervention
Change from baseline Temporal Summation (evaluated by VNRS) immediately after the intervention
Time frame: Baseline and immediately 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 26 Jan 2023.
- Background: PubMed 28135129Garcia Bermejo P, De La Cruz Torres B, Naranjo Orellana J, Albornoz Cabello M. Autonomic Responses to Ultrasound-Guided Percutaneous Needle Electrolysis: Effect of Needle Puncture or Electrical Current? J Altern Complement Med. 2018 Jan;24(1):69-75. doi: 10.1089/acm.2016.0339. Epub 2017 Jan 30.
- 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.
- Background: PubMed 25332934Abat F, Diesel WJ, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibanez JM. Effectiveness of the Intratissue Percutaneous Electrolysis (EPI(R)) technique and isoinertial eccentric exercise in the treatment of patellar tendinopathy at two years follow-up. Muscles Ligaments Tendons J. 2014 Jul 14;4(2):188-93. eCollection 2014 Apr.
- Background: PubMed 25699686Nir RR, Yarnitsky D. Conditioned pain modulation. Curr Opin Support Palliat Care. 2015 Jun;9(2):131-7. doi: 10.1097/SPC.0000000000000126.
- Background: PubMed 31354339Fernandez-de-Las-Penas C, Nijs J. Trigger point dry needling for the treatment of myofascial pain syndrome: current perspectives within a pain neuroscience paradigm. J Pain Res. 2019 Jun 18;12:1899-1911. doi: 10.2147/JPR.S154728. eCollection 2019.
- Background: PubMed 30146050Damien J, Colloca L, Bellei-Rodriguez CE, Marchand S. Pain Modulation: From Conditioned Pain Modulation to Placebo and Nocebo Effects in Experimental and Clinical Pain. Int Rev Neurobiol. 2018;139:255-296. doi: 10.1016/bs.irn.2018.07.024. Epub 2018 Aug 14.
- Derived from this study: PubMed 37847947Sanchez-Gonzalez JL, Navarro-Lopez V, Calderon-Diez L, Varela-Rodriguez S, Fernandez-de-Las-Penas C, Sanchez-Sanchez JL. Effectiveness of different percutaneous electrolysis protocols in the endogenous modulation of pain: A Double-Blinded Randomized Clinical Trial. Musculoskelet Sci Pract. 2023 Nov;68:102872. doi: 10.1016/j.msksp.2023.102872. Epub 2023 Oct 11.
- 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 Isolated needling procedure, Low intensity percutaneous electrolysis and High intensity percutaneous electrolysis in people with Pain, run by University of Salamanca 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 11 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 26 Jan 2023. 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. 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?
Change from baseline Conditioned Pain Modulation (evaluated by pressure algometry) immediately after the intervention (time frame: Baseline and immediately after the 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 NCT04710992, which also lists 7 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 26 Jan 2023.