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NCT Number: NCT06938425

Effectiveness of Percutaneous Electrolysis and Dry Needling vs. Standard Therapy for Whiplash Syndrome

The main objective of this research is to evaluate the effectiveness of two interventions (PIE vs DDN) in adult patients who have suffered a LCS after a traffic accident and comparing it with a standard physiotherapy program. As a secondary objective, the investigators will analyze the reduction of intrafibrillar blood flow and muscle elasticity perceived by the patient in the long term and the reduction of pain and disability appreciated by the patient.

It is hypothesized as an alternative hypothesis that percutaneous electrolysis and/or deep dry needling intervention in combination with standard physiotherapy will give better clinical outcomes in patients with active trigger point LCS following a road traffic accident compared to the current standard physiotherapy intervention.

The researchers will compare both invasive physical therapy techniques with standard treatment to see if these techniques are more effective in treating whiplash syndrome.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The present study primarily aims to evaluate the clinical effectiveness of two invasive physiotherapy techniques-percutaneous intratissue electrolysis (PIE) and deep dry needling (DDN)-combined with conventional physiotherapy, compared to a standard physiotherapy program in adult patients who have sustained a whiplash-associated disorder (WAD) following a motor vehicle accident.

Whiplash injury is one of the most common musculoskeletal sequelae after traffic accidents, often leading to chronic pain and functional disability. The heterogeneity of clinical responses and the persistence of symptoms underscore the need for optimized therapeutic strategies supported by high-quality evidence.

This prospective, randomized controlled trial (RCT) will include three parallel intervention arms:

Control group: standard physiotherapy based on therapeutic exercise and manual therapy techniques.

Experimental group 1: standard physiotherapy + PIE intervention.

Experimental group 2: standard physiotherapy + DDN intervention.

The study population will consist of adult subjects diagnosed with WAD and the presence of active myofascial trigger points in the cervical musculature. Participants will be randomly assigned to one of the three groups, and interventions will be administered over a predetermined period, with follow-up assessments scheduled at both short- and long-term intervals.

Secondary outcomes include:

Changes in intrafibrillar blood flow Patient-reported muscle elasticity, Self-reported pain levels Functional disability

The alternative hypothesis proposes that the application of invasive techniques (PIE or DDN) as an adjunct to conventional physiotherapy will yield superior clinical outcomes in terms of pain reduction, functional improvement, and muscle parameter normalization when compared to standard physiotherapy alone.

This study aims to generate robust scientific evidence regarding the comparative efficacy of these interventions and to inform clinical decision-making in the rehabilitative management of post-traumatic whiplash-associated disorders.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults with whiplash syndrome following a traffic accident.
  • Patients must reside or stay in the Autonomous Community of Melilla during the intervention phase.
  • Subjects will have the presence of neck pain after suffering a traffic accident and the presence of at least one active trigger point in the sternocleidomastoid and/or levator scapulae muscles.
  • All subjects who suffer a traffic accident and who have a score of 5 or higher on the numerical scale (EN) of pain assessment.

Exclusion criteria

  • Patients undergoing anticoagulant treatment.
  • Patients who have suffered previous cervical trauma or who have undergone surgery in the last year.
  • Subjects who present some type of alteration (skin or infection, sensitivity or pain perception).
  • Subjects with central or peripheral nervous system involvement.
  • Patients who have problems with the material: allergy to metal, belonephobia (fear of needles).
  • Pregnant women.

Treatment and study plan

intratissue percutaneous electrolysis

Other

Using fine needles guided by ultrasound to apply electrical stimulation directly to the affected tissue (for example, damaged muscles or tendons).

Deep Dry Needling

Other

Insertion of fine needles into muscle trigger points (without injection of drugs) to relieve muscle pain and release tension.

standard physiotherapy

Procedure

It includes manual techniques such as therapeutic massage and mobilization, along with stretching and strengthening exercises to improve range of motion and reduce pain.

Primary outcomes

  1. Intrafibrillar blood flow

    Time frame: From the beginning of treatment to the end of treatment at 4 weeks and at 3 months

    To assess intrafibrillar blood flow, the ultrasound tool is used, with color Doppler. the hypervascularity of small vessels in the inflamed synovial tissue of the structures is evaluated. Measurements are expressed in liters per minute (l/min).

  2. Elasticity of muscle fibers

    Time frame: From the beginning of treatment to the end of treatment at 4 weeks and at 3 months

    Elastography is used to evaluate the elasticity of muscle fibers. It is a grayscale ultrasound technique that is superimposed on the color parametric image that expresses the rate of tissue deformation.Making it possible to express the stiffness and elasticity of the tissue in units of pressure (kilopascals).

Secondary outcomes

  1. Pain perceived by the patient

    Time frame: From the beginning of treatment to the end of treatment at 4 weeks and at 3 months

    Pain is a quantitative variable. The investigators will use the numerical evaluation scale (EN), which consists of a numbered scale from 1 -10.

  2. Pain perceived by the patient

    Time frame: From the beginning of treatment to the end of treatment at 4 weeks and at 3 months

    Another pain variable is the pressure pain threshold (PPT), which is an unpleasant sensory and emotional experience associated with a present injury and a pressure algometer will be used. Measurements are expressed in kg/cm2.

  3. Disability

    Time frame: From the beginning of treatment to the end of treatment at 4 weeks and at 3 months

    To assess disability, the investigators will use the Whiplash Disability Questionnaire (WDQ) scale. It is the first instrument for patients with whiplash syndrome, which includes items related to areas of life, personal care and work and those related to the perception of pain. This questionnaire consists of 13 items, scored from 0 to 10 points.

Study contacts

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

José M. Pérez Ortiz, PhD

CONTACT

[email protected]

+34918153131

Rocío Fernández Navarro

CONTACT

[email protected]

+34667201750

Sponsors and collaborators

Lead sponsor

Camilo Jose Cela University

Other

Registry information

Official study title

Effectiveness of Intratissue Percutaneous Electrolysis and Deep Dry Needling Versus a Standard Physical Therapy Protocol in the Treatment of Whiplash Syndrome in the Short and Medium Term

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2025
Registry last updated
Nov 26, 2025

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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