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临床试验/NCT07269925
NCT07269925招募中不适用

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

Universidad Complutense de Madrid3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
3
主要终点
Muscle strength

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Low Frequency PENS

Experimental

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.

干预措施: Percutaneous electrical nerve stimulation: Low frequency (Other)

High Frequency PENS

Experimental

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.

干预措施: Percutaneous electrical nerve stimulation: High frequency (Other)

结局指标

主要结局

Muscle strength

时间窗: 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°.

Muscle strength

时间窗: 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°.

次要结局

  • Pain Pressure Thresholds - Latent MTrP(Baseline)
  • Pain Pressure Thresholds - Tibialis anterior(Baseline)
  • Pain Pressure Thresholds - Tibialis anterior(Post-intervention (10 minutes))
  • Pain Pressure Thresholds - Latent MTrP(Post-intervention (10 minutes))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JUAN ANTONIO VALERA CALERO

Principal Investigator

Universidad Complutense de Madrid

研究点 (3)

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