Chronic Neck PainNCT07345793
Effects of Minimally Invasive Techniques in Healthy and Chronic Cervical Pain Individuals
A study testing Dry needling, Percutaneous nerve stimulation and Percutaneous electrolysis in people with Chronic Neck Pain, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
Brief Summary: This project consists of two sequential experimental phases designed to analyze the immediate and 24-hour effects of three invasive physiotherapy techniques -dry needling (DN), percutaneous neuromodulation (PENS), and percutaneous electrolysis (EPE)- on muscle tone and pain perception. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Dry needling, Percutaneous nerve stimulation and Percutaneous electrolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 19 Jan 2026to 2 Feb 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
- Age between 18 and 65 years.
- Healthy individuals without any current musculoskeletal or neurological pathology.
- Presence of a palpable myofascial trigger point in the upper trapezius muscle.
- No neck or shoulder pain requiring medical treatment in the past three months.
- Willingness to refrain from other physiotherapy or manual therapy interventions during the study period.
- Ability to understand and provide written informed consent
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- Phase 2 - Patients with Chronic Neck Pain
- Age between 18 and 65 years.
- Diagnosis of chronic mechanical or tension-type neck pain lasting for at least 3 months.
- Presence of at least one active myofascial trigger point in the upper trapezius muscle.
- Pain intensity between 3 and 7 on a 10-cm Visual Analog Scale (VAS) at baseline.
- No previous invasive physiotherapy treatments (dry needling, electrolysis, or neuromodulation) within the last 4 weeks.
- Ability and willingness to attend all study sessions and follow-up assessments.
- Signed informed consent before participation.
Who cannot join
- History of cervical or shoulder surgery.
- Neurological, systemic, or rheumatologic disorders affecting the cervical or upper limb region.
- Anticoagulant therapy or known bleeding disorders.
- Pregnancy or suspected pregnancy.
- Skin infection, wound, or dermatological condition at or near the intervention site.
- Use of analgesic, anti-inflammatory, or muscle relaxant medications within 48 hours prior to the intervention.
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- Prior invasive physiotherapy (dry needling, PENS, or EPE) in the target area during the past month.
- Contraindications to electrical stimulation (for PENS or EPE groups), such as implanted pacemaker or metal implants near the treatment area.
- Fear of needles (trypanophobia) or intolerance to invasive procedures.
- Participation in another clinical trial within the past 3 months.
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mmediate and Short-Term Effects of Dry Needling, Percutaneous Neuromodulation, and Percutaneous Electrolysis on Muscle Tone and Pain: A Two-Phase Randomized Experimental Study in Healthy Subjects and Patients With Chronic Neck Pain.
Brief Summary:
This project consists of two sequential experimental phases designed to analyze the immediate and 24-hour effects of three invasive physiotherapy techniques -dry needling (DN), percutaneous neuromodulation (PENS), and percutaneous electrolysis (EPE)- on muscle tone and pain perception.
Read more
In the first phase, the study will be conducted on healthy volunteers to assess the physiological responses and safety profile of the interventions under controlled conditions. Each participant will receive one of the three randomly assigned interventions (DN, PENS, or EPE), applied to the upper trapezius muscle. Pain perception (Visual Analog Scale, VAS) and muscle mechanical properties (tone, stiffness, and elasticity) will be measured before and after the intervention, and after 24 hours, using the MyotonPRO device.
In the second phase, the same protocol and parameters will be applied to patients with chronic neck pain, in order to compare the magnitude and persistence of the effects between healthy subjects and symptomatic individuals.
This study aims to improve understanding of the short-term physiological mechanisms of invasive physiotherapy techniques and their relative effectiveness in managing chronic neck pain. The findings will contribute to the development of more precise and evidence-based treatment protocols for musculoskeletal pain.
- Conditions
- Chronic Neck Pain
- Being tested
- Dry needling, Percutaneous nerve stimulation, Percutaneous electrolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingProcedure or surgery
Dry needling will be performed on the upper trapezius muscle at an active myofascial trigger point. A sterile, single-use solid filament needle (0.30 × 40 mm) will be inserted until eliciting three local twitch responses (LTRs). The needle will then be withdrawn immediately after obtaining the final response. The technique aims to normalize motor endplate activity and reduce local and referred pain through mechanical and neurophysiological modulation.
Percutaneous nerve stimulationProcedure or surgery
Percutaneous neuromodulation will be applied using a sterile acupuncture needle (0.30 × 40 mm) inserted near the accessory nerve pathway in the upper trapezius region. A low-frequency alternating current (10 Hz, 250 μs pulse width) will be delivered for 15 minutes using an electrotherapy device approved for clinical use. The objective is to modulate neuromuscular excitability and decrease pain perception through peripheral and central mechanisms.
Percutaneous electrolysisProcedure or surgery
Percutaneous electrolysis will be performed by inserting a sterile acupuncture needle (0.30 × 40 mm) into the active myofascial trigger point of the upper trapezius. A galvanic current of 1 mA will be applied for three impacts of 5 seconds each using an approved electrolysis device. This technique produces a controlled local inflammatory response, promoting tissue regeneration and analgesia through electrochemical and neurophysiological effects.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Not described Receives: Procedure: Dry needling |
| Percutaneous electrical nerve stimulation | Experimental | Not described Receives: Procedure: Percutaneous nerve stimulation |
| Percutaneous electrolysis | Experimental | Not described Receives: Procedure: Percutaneous electrolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain perception will be measured using a 10 cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain. Participants will mark their perceived pain intensity at rest. The scale is a reliable and validated tool for assessing subjective pain in musculoskeletal disorders.
Measured: Baseline (pre-intervention), immediately post-intervention, and 24 hours post-intervention.
Secondary outcomes (3)
Muscle tone
Muscle tone will be assessed using the MyotonPRO device, which measures the natural oscillation frequency (Hz) of the muscle at rest. The upper trapezius will be evaluated at a standardized point corresponding to the active myofascial trigger point region. Higher frequency values indicate increased muscle tone.
Measured: Baseline and immediately post-intervention, and 24 hours post-intervention
Muslce stiffness
Muscle stiffness will be evaluated using the MyotonPRO, which calculates the muscle's resistance to deformation expressed in newtons per meter (N/m). This parameter reflects the biomechanical rigidity of the tissue.
Measured: Baseline, immediately post intervention and 24 hours post-intervention
Muscle elasticity
Elasticity will be measured with the MyotonPRO, expressed as the logarithmic decrement of the muscle's oscillation. Lower values indicate greater elasticity and better recovery capacity after deformation.
Measured: Baseline, immedialely post intervention and 24 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start19 Jan 2026
- Primary completion28 Jan 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Neck 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
- This study is designed as a two-phase randomized experimental trial with parallel group assignment. In the first phase, healthy volunteers will be randomly assigned to one of three intervention groups: 1. Dry Needling (DN) - mechanical stimulation of an active myofascial trigger point in the upper trapezius. 2. Percutaneous Neuromodulation (PENS) - low-frequency electrical stimulation applied near the accessory nerve through an acupuncture needle. 3. Percutaneous Electrolysis (EPE) - galvanic current (1 mA, three impacts of 5 seconds) applied through a needle at the trigger point. All participants will undergo a single treatment session. Assessments of pain intensity (VAS) and muscle mechanical properties (tone, stiffness, elasticity measured by MyotonPRO) will be performed before the intervention, immediately after, and 24 hours later. In the second phase, the same study design, intervention parameters, and outcome measures will be applied to a population of patients with chroni
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 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
- NCT07345793
- Sponsor's protocol ID
- 25/787-EC_X
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernández-de-Las-Peñas C., Dommerholt J. Myofascial Trigger Points: Pathophysiology and Evidence-Informed Diagnosis and Management. Pain Medicine. 2018.
Abat F. et al. Effectiveness of percutaneous electrolysis for tendinopathies. Br J Sports Med. 2015.
Rodríguez-Sanz J. et al. Dry Needling in the Management of Musculoskeletal Pain. Brazilian Journal of Physical Therapy. 2014.
Pirri C, Manocchio N, Sorbino A, Pirri N, Foti C. Percutaneous Electrolysis for Musculoskeletal Disorders Management in Rehabilitation Settings: A Systematic Review. Healthcare (Basel). 2025 Jul 23;13(15):1793. doi: 10.3390/healthcare13151793.
PubMed 40805826Hoy D, March L, Woolf A, Blyth F, Brooks P, Smith E, Vos T, Barendregt J, Blore J, Murray C, Burstein R, Buchbinder R. The global burden of neck pain: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1309-15. doi: 10.1136/annrheumdis-2013-204431. Epub 2014 Jan 30.
PubMed 24482302Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.
PubMed 15999284
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mmediate and Short-Term Effects of Dry Needling, Percutaneous Neuromodulation, and Percutaneous Electrolysis on Muscle Tone and Pain: A Two-Phase Randomized Experimental Study in Healthy Subjects and Patients With Chronic Neck Pain.
- ClinicalTrials.gov ID
- NCT07345793
- Acronym / sponsor ID
- 25/787-EC_X
- Conditions
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 16 Jan 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.
Brief Summary:
This project consists of two sequential experimental phases designed to analyze the immediate and 24-hour effects of three invasive physiotherapy techniques -dry needling (DN), percutaneous neuromodulation (PENS), and percutaneous electrolysis (EPE)- on muscle tone and pain perception.
In the first phase, the study will be conducted on healthy volunteers to assess the physiological responses and safety profile of the interventions under controlled conditions. Each participant will receive one of the three randomly assigned interventions (DN, PENS, or EPE), applied to the upper trapezius muscle. Pain perception (Visual Analog Scale, VAS) and muscle mechanical properties (tone, stiffness, and elasticity) will be measured before and after the intervention, and after 24 hours, using the MyotonPRO device.
In the second phase, the same protocol and parameters will be applied to patients with chronic neck pain, in order to compare the magnitude and persistence of the effects between healthy subjects and symptomatic individuals.
This study aims to improve understanding of the short-term physiological mechanisms of invasive physiotherapy techniques and their relative effectiveness in managing chronic neck pain. The findings will contribute to the development of more precise and evidence-based treatment protocols for musculoskeletal pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study is designed as a two-phase randomized experimental trial with parallel group assignment. In the first phase, healthy volunteers will be randomly assigned to one of three intervention groups: 1. Dry Needling (DN) - mechanical stimulation of an active myofascial trigger point in the upper trapezius. 2. Percutaneous Neuromodulation (PENS) - low-frequency electrical stimulation applied near the accessory nerve through an acupuncture needle. 3. Percutaneous Electrolysis (EPE) - galvanic current (1 mA, three impacts of 5 seconds) applied through a needle at the trigger point. All participants will undergo a single treatment session. Assessments of pain intensity (VAS) and muscle mechanical properties (tone, stiffness, elasticity measured by MyotonPRO) will be performed before the intervention, immediately after, and 24 hours later. In the second phase, the same study design, intervention parameters, and outcome measures will be applied to a population of patients with chroni
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Procedure: Dry needling |
| Percutaneous electrical nerve stimulation | Experimental | Procedure: Percutaneous nerve stimulation |
| Percutaneous electrolysis | Experimental | Procedure: Percutaneous electrolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age between 18 and 65 years.
- Healthy individuals without any current musculoskeletal or neurological pathology.
- Presence of a palpable myofascial trigger point in the upper trapezius muscle.
- No neck or shoulder pain requiring medical treatment in the past three months.
- Willingness to refrain from other physiotherapy or manual therapy interventions during the study period.
Key exclusion criteria (11 listed)
- History of cervical or shoulder surgery.
- Neurological, systemic, or rheumatologic disorders affecting the cervical or upper limb region.
- Anticoagulant therapy or known bleeding disorders.
- Pregnancy or suspected pregnancy.
- Skin infection, wound, or dermatological condition at or near the intervention site.
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 |
|---|---|---|
| Dry needlingDry needling will be performed on the upper trapezius muscle at an active myofascial trigger point. A sterile, single-use solid filament needle (0.30 × 40 mm) will be inserted until eliciting three local twitch responses (LTRs). The needle will then be withdrawn immediately after obtaining the final response. The technique aims to normalize motor endplate activity and reduce local and referred pain through mechanical and neurophysiological modulation. | Procedure or surgery | Dry needling |
| Percutaneous nerve stimulationPercutaneous neuromodulation will be applied using a sterile acupuncture needle (0.30 × 40 mm) inserted near the accessory nerve pathway in the upper trapezius region. A low-frequency alternating current (10 Hz, 250 μs pulse width) will be delivered for 15 minutes using an electrotherapy device approved for clinical use. The objective is to modulate neuromuscular excitability and decrease pain perception through peripheral and central mechanisms. | Procedure or surgery | Percutaneous electrical nerve stimulation |
| Percutaneous electrolysisPercutaneous electrolysis will be performed by inserting a sterile acupuncture needle (0.30 × 40 mm) into the active myofascial trigger point of the upper trapezius. A galvanic current of 1 mA will be applied for three impacts of 5 seconds each using an approved electrolysis device. This technique produces a controlled local inflammatory response, promoting tissue regeneration and analgesia through electrochemical and neurophysiological effects. | Procedure or surgery | Percutaneous electrolysis |
Primary outcome
Pain intensity
Time frame: Baseline (pre-intervention), immediately post-intervention, and 24 hours post-intervention.
Pain perception will be measured using a 10 cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain. Participants will mark their perceived pain intensity at rest. The scale is a reliable and validated tool for assessing subjective pain in musculoskeletal disorders.
3 secondary outcomes
Muscle tone
Time frame: Baseline and immediately post-intervention, and 24 hours post-intervention
Muslce stiffness
Time frame: Baseline, immediately post intervention and 24 hours post-intervention
Muscle elasticity
Time frame: Baseline, immedialely post intervention and 24 hours post 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 18 Feb 2026.
- Results publicationFernández-de-Las-Peñas C., Dommerholt J. Myofascial Trigger Points: Pathophysiology and Evidence-Informed Diagnosis and Management. Pain Medicine. 2018.
- Results publicationAbat F. et al. Effectiveness of percutaneous electrolysis for tendinopathies. Br J Sports Med. 2015.
- Results publicationRodríguez-Sanz J. et al. Dry Needling in the Management of Musculoskeletal Pain. Brazilian Journal of Physical Therapy. 2014.
- Results publication: PubMed 40805826Pirri C, Manocchio N, Sorbino A, Pirri N, Foti C. Percutaneous Electrolysis for Musculoskeletal Disorders Management in Rehabilitation Settings: A Systematic Review. Healthcare (Basel). 2025 Jul 23;13(15):1793. doi: 10.3390/healthcare13151793.
- Results publication: PubMed 24482302Hoy D, March L, Woolf A, Blyth F, Brooks P, Smith E, Vos T, Barendregt J, Blore J, Murray C, Burstein R, Buchbinder R. The global burden of neck pain: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1309-15. doi: 10.1136/annrheumdis-2013-204431. Epub 2014 Jan 30.
- Results publication: PubMed 15999284Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.
- 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. 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 Dry needling, Percutaneous nerve stimulation and Percutaneous electrolysis in people with Chronic Neck Pain, run by Universidad Europea de Madrid 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 14 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 18 Feb 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 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?
Pain intensity (time frame: Baseline (pre-intervention), immediately post-intervention, and 24 hours post-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 NCT07345793, which also lists 6 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 18 Feb 2026.