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Impact of Different Electrical Frequencies Used in Percutaneous Neuromodulation on Muscle Strength and Pressure Pain Thresholds

Impact of Different Electrical Frequencies Used in Percutaneous Neuromodulation on Muscle Strength and Pressure Pain Thresholds

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07269925
Acronym
PENS-DOSE
Enrollment
30
Registered
2025-12-08
Start date
2026-02-15
Completion date
2026-07-30
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

Keywords

Percutaneous electrical nerve stimulation, Strength, Pain pressure thresholds

Brief summary

Percutaneous electrical nerve stimulation (PENS) involves delivering electrical currents through fine filiform needles inserted near tissues such as muscles, ligaments, or nerves. It has been explored for various chronic pain conditions affecting the cervical and lumbar spine, as well as the upper and lower limbs. Despite its growing clinical use, the overall quality of evidence supporting PENS for chronic musculoskeletal pain remains limited. Most studies have applied the technique directly over nerve structures, and while some reviews have shown greater pain reduction compared to transcutaneous electrical nerve stimulation (TENS), the superiority of PENS has not been conclusively demonstrated. Research specifically examining its application on nerve tissues, particularly in the upper limbs, remains scarce. Some preliminary and single-case studies have reported improvements in pain and disability following PENS directed at the radial nerve, but these findings are limited by small sample sizes and the absence of control groups. The physiological mechanisms underlying PENS are still not fully understood, though both peripheral and central processes are believed to be involved. Evidence suggests that PENS can reduce local sensitivity to pressure pain through peripheral mechanisms and may also enhance descending inhibitory control by activating conditioned pain modulation at the central level. However, further studies are necessary to clarify these effects. Since to date, limited research has specifically examined the optimal PENS dosage, the present study aimed to compare two PENS dosage for improving muscle strength and pain pressure thresholds.

Interventions

OTHERPercutaneous electrical nerve stimulation: Low frequency

A single PENS session will be applied under ultrasound guidance using sterile, single-use filiform needles placed in the suprascapular and axillary nerves and connected to an electrostimulator APSe4 (Agupunt, Barcelona). Dosage will be: 2 Hz frequency, 250 µs pulse width, 10 minutes duration, with an intensity (mA) sufficient to elicit a visible motor response while remaining comfortable for the patient.

OTHERPercutaneous electrical nerve stimulation: High frequency

A single PENS session will be applied under ultrasound guidance using sterile, single-use filiform needles placed in the suprascapular and axillary nerves and connected to an electrostimulator APSe4 (Agupunt, Barcelona). Dosage will be: 100 Hz frequency, 250 µs pulse width, 5-second stimulation followed by 55-second rest, repeated five times

Sponsors

Universidad Complutense de Madrid
Lead SponsorOTHER
Universidad Rey Juan Carlos
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Randomized, Double-Blinded, Placebo-Controlled Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Presence of at least one latent myofascial trigger point (MTrP) in the infraspinatus muscle, identified according to the most recent Delphi consensus criteria. * Ability to read, understand, and sign the written informed consent form.

Exclusion criteria

* Current pharmacological treatment that may affect muscle tone. * History of shoulder or spinal surgery. * Traumatic disorders such as whiplash-associated injuries, dislocations, or fractures. * Neuropathies, including radiculopathies or myelopathies. * Severe medical conditions (e.g., tumors, fractures, neurological or systemic diseases). * Clinically relevant asymmetries. * Generalized musculoskeletal conditions such as fibromyalgia.

Design outcomes

Primary

MeasureTime frameDescription
Muscle strengthBaselineShoulder external rotator strength will be assessed using a handheld dynamometer (TruStrength, Hawkin Dynamics, USA), previously validated for measuring isometric muscle contraction strength. Participants will perform a standardized isometric external rotation test in a seated position with the elbow flexed at 90°.

Secondary

MeasureTime frameDescription
Pain Pressure Thresholds - Latent MTrPBaselineThe assessment of pressure pain thresholds (PPT) at the myofascial trigger point (MTrP) will be evaluated three times at each measurement site using a analog algometer, applying a pressure rate of approximately 5 N/s.
Pain Pressure Thresholds - Tibialis anteriorBaselineThe assessment of pressure pain thresholds (PPT) at a distal location (Tibia's anterior) will be evaluated three times at each measurement site using a analog algometer, applying a pressure rate of approximately 5 N/s.

Countries

Poland

Contacts

CONTACTJuan Antonio Valera-Calero, PhD
juavaler@ucm.es0034 653 766 841

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026