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Recruiting NCT07269925

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

No phase Interventional Shoulder Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Percutaneous electrical nerve stimulation: High frequency, Percutaneous electrical nerve stimulation: Low frequency.
Who it may be relevant to
Registry conditions: Shoulder Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other Percutaneous 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
  • Other Percutaneous 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.

Primary outcome measures

  • Muscle strength [Time frame: Baseline]
  • Muscle strength [Time frame: Post-intervention (10 minutes)]
Secondary outcome measures (4)
  • Pain Pressure Thresholds - Latent MTrP [Time frame: Baseline]
  • Pain Pressure Thresholds - Latent MTrP [Time frame: Post-intervention (10 minutes)]
  • Pain Pressure Thresholds - Tibialis anterior [Time frame: Baseline]
  • Pain Pressure Thresholds - Tibialis anterior [Time frame: Post-intervention (10 minutes)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Poland · 2 centers
  • ATMIS — Krakow
  • ATMIS — Nowy Targ

Identifiers

NCT: NCT07269925 · UComplutenseMadrid-PENS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗