Impact of Different Electrical Frequencies Used in Percutaneous Neuromodulation on Muscle Strength and Pressure Pain Thresholds (PENS-DOSE)

Universidad Complutense de Madrid

Status: Begins enrollment this month

Conditions: Shoulder Pain

Treatments: Other: Percutaneous electrical nerve stimulation: High frequency; Other: Percutaneous electrical nerve stimulation: Low frequency

Study type: Interventional

Funder types: Other

Identifiers

NCT07269925

UComplutenseMadrid-PENS

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Low Frequency PENS

Experimental group

Description:

Participants will receive a single session of PENS setting 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.

Treatment:

Other: Percutaneous electrical nerve stimulation: Low frequency

High Frequency PENS

Experimental group

Description:

Participants will receive a single session of PENS setting 100 Hz frequency, 250 µs pulse width, 5-second stimulation followed by 55-second rest, with an intensity (mA) sufficient to elicit a visible motor response while remaining comfortable for the patient and repeated five times.

Treatment:

Other: Percutaneous electrical nerve stimulation: High frequency