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NCT Number: NCT07269925

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ATMIS, Krakow, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous electrical nerve stimulation: High frequency

Other

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

Percutaneous electrical nerve stimulation: Low frequency

Other

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.

Primary outcomes

  1. Muscle strength

    Time frame: Baseline

    Shoulder 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°.

  2. Muscle strength

    Time frame: Post-intervention (10 minutes)

    Shoulder 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 outcomes

  1. Pain Pressure Thresholds - Latent MTrP

    Time frame: Baseline

    The 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.

  2. Pain Pressure Thresholds - Latent MTrP

    Time frame: Post-intervention (10 minutes)

    The 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.

  3. Pain Pressure Thresholds - Tibialis anterior

    Time frame: Baseline

    The 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.

  4. Pain Pressure Thresholds - Tibialis anterior

    Time frame: Post-intervention (10 minutes)

    The 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Antonio Valera-Calero, PhD

CONTACT

[email protected]

0034 653 766 841

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Universidad Rey Juan Carlos

Registry information

Acronym: PENS-DOSE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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