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OpenTrials
Completed

NCT Number: NCT07345793

Effects of Minimally Invasive Techniques in Healthy and Chronic Cervical Pain Individuals

Brief Summary:

This project consists of two sequential experimental phases designed to analyze the immediate and 24-hour effects of three invasive physiotherapy techniques -dry needling (DN), percutaneous neuromodulation (PENS), and percutaneous electrolysis (EPE)- on muscle tone and pain perception.

In the first phase, the study will be conducted on healthy volunteers to assess the physiological responses and safety profile of the interventions under controlled conditions. Each participant will receive one of the three randomly assigned interventions (DN, PENS, or EPE), applied to the upper trapezius muscle. Pain perception (Visual Analog Scale, VAS) and muscle mechanical properties (tone, stiffness, and elasticity) will be measured before and after the intervention, and after 24 hours, using the MyotonPRO device.

In the second phase, the same protocol and parameters will be applied to patients with chronic neck pain, in order to compare the magnitude and persistence of the effects between healthy subjects and symptomatic individuals.

This study aims to improve understanding of the short-term physiological mechanisms of invasive physiotherapy techniques and their relative effectiveness in managing chronic neck pain. The findings will contribute to the development of more precise and evidence-based treatment protocols for musculoskeletal pain.

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Key information

Conditions

Chronic Neck Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antonio Rejas Fisioterapia

Cuenca, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Phase 1 - healthy subjects

  • Age between 18 and 65 years.
  • Healthy individuals without any current musculoskeletal or neurological pathology.
  • Presence of a palpable myofascial trigger point in the upper trapezius muscle.
  • No neck or shoulder pain requiring medical treatment in the past three months.
  • Willingness to refrain from other physiotherapy or manual therapy interventions during the study period.
  • Ability to understand and provide written informed consent

Phase 2 - Patients with Chronic Neck Pain

  • Age between 18 and 65 years.
  • Diagnosis of chronic mechanical or tension-type neck pain lasting for at least 3 months.
  • Presence of at least one active myofascial trigger point in the upper trapezius muscle.
  • Pain intensity between 3 and 7 on a 10-cm Visual Analog Scale (VAS) at baseline.
  • No previous invasive physiotherapy treatments (dry needling, electrolysis, or neuromodulation) within the last 4 weeks.
  • Ability and willingness to attend all study sessions and follow-up assessments.
  • Signed informed consent before participation.

Exclusion criteria

  • History of cervical or shoulder surgery.
  • Neurological, systemic, or rheumatologic disorders affecting the cervical or upper limb region.
  • Anticoagulant therapy or known bleeding disorders.
  • Pregnancy or suspected pregnancy.
  • Skin infection, wound, or dermatological condition at or near the intervention site.
  • Use of analgesic, anti-inflammatory, or muscle relaxant medications within 48 hours prior to the intervention.
  • Prior invasive physiotherapy (dry needling, PENS, or EPE) in the target area during the past month.
  • Contraindications to electrical stimulation (for PENS or EPE groups), such as implanted pacemaker or metal implants near the treatment area.
  • Fear of needles (trypanophobia) or intolerance to invasive procedures.
  • Participation in another clinical trial within the past 3 months.
  • Refusal or inability to provide informed consent

Treatment and study plan

dry needling

Procedure

Dry needling will be performed on the upper trapezius muscle at an active myofascial trigger point. A sterile, single-use solid filament needle (0.30 × 40 mm) will be inserted until eliciting three local twitch responses (LTRs). The needle will then be withdrawn immediately after obtaining the final response. The technique aims to normalize motor endplate activity and reduce local and referred pain through mechanical and neurophysiological modulation.

Percutaneous nerve stimulation

Procedure

Percutaneous neuromodulation will be applied using a sterile acupuncture needle (0.30 × 40 mm) inserted near the accessory nerve pathway in the upper trapezius region. A low-frequency alternating current (10 Hz, 250 μs pulse width) will be delivered for 15 minutes using an electrotherapy device approved for clinical use. The objective is to modulate neuromuscular excitability and decrease pain perception through peripheral and central mechanisms.

Percutaneous electrolysis

Procedure

Percutaneous electrolysis will be performed by inserting a sterile acupuncture needle (0.30 × 40 mm) into the active myofascial trigger point of the upper trapezius. A galvanic current of 1 mA will be applied for three impacts of 5 seconds each using an approved electrolysis device. This technique produces a controlled local inflammatory response, promoting tissue regeneration and analgesia through electrochemical and neurophysiological effects.

Primary outcomes

  1. Pain intensity

    Time frame: Baseline (pre-intervention), immediately post-intervention, and 24 hours post-intervention.

    Pain perception will be measured using a 10 cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain. Participants will mark their perceived pain intensity at rest. The scale is a reliable and validated tool for assessing subjective pain in musculoskeletal disorders.

Secondary outcomes

  1. Muscle tone

    Time frame: Baseline and immediately post-intervention, and 24 hours post-intervention

    Muscle tone will be assessed using the MyotonPRO device, which measures the natural oscillation frequency (Hz) of the muscle at rest. The upper trapezius will be evaluated at a standardized point corresponding to the active myofascial trigger point region. Higher frequency values indicate increased muscle tone.

  2. Muslce stiffness

    Time frame: Baseline, immediately post intervention and 24 hours post-intervention

    Muscle stiffness will be evaluated using the MyotonPRO, which calculates the muscle's resistance to deformation expressed in newtons per meter (N/m). This parameter reflects the biomechanical rigidity of the tissue.

  3. Muscle elasticity

    Time frame: Baseline, immedialely post intervention and 24 hours post intervention

    Elasticity will be measured with the MyotonPRO, expressed as the logarithmic decrement of the muscle's oscillation. Lower values indicate greater elasticity and better recovery capacity after deformation.

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

Mmediate and Short-Term Effects of Dry Needling, Percutaneous Neuromodulation, and Percutaneous Electrolysis on Muscle Tone and Pain: A Two-Phase Randomized Experimental Study in Healthy Subjects and Patients With Chronic Neck Pain.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Feb 18, 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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