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Not yet recruitingNCT06938425Updated Nov 26, 2025

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

An interventional study of intratissue percutaneous electrolysis and deep dry needling in Whiplash Injuries, sponsored by Camilo Jose Cela University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-26.

Sponsored by Camilo Jose Cela University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Whiplash Injuries

Keywords

  • Percutaneous electrolysis
  • Dry needling
  • Whiplash
  • Myofascial pain syndrome
  • Myofascial trigger point
  • Intrafibrillar blood flow
  • elasticity
03

In context

Whiplash Injuries

68 studies on the registry are indexed under Whiplash Injuries; 8 are open to participants now.

This study's planned enrollment of 36 is below the median of 68 across 49 interventional studies indexed under Whiplash Injuries.

Browse Whiplash Injuries studies →

Lead sponsor

Camilo Jose Cela University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Active comparator
    standard physiotherapy treatment

    Participants in this group will receive standard physical therapy sessions, including manual techniques, massage therapy and mobility exercises.

    Procedure: Standard physiotherapy

  • Experimental
    intratissue percutaneous electrolysis

    Participants in this group will receive physiotherapy sessions using the Percutaneous Intratisular Electrolysis (EPI) technique,

    Other: intratissue percutaneous electrolysis

  • Experimental
    Deep Dry needling

    Participants in this group will receive physiotherapy sessions using the dry puncture technique applied to active trigger points.

    Other: deep dry needling

Interventions

  • Otherintratissue percutaneous electrolysis

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

  • Otherdeep dry needling

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

  • ProcedureStandard physiotherapy

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

06

What researchers measure

Primary outcomes

  1. Intrafibrillar blood flow

    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).

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

  2. Elasticity of muscle fibers

    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).

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

Secondary outcomes

  1. Pain perceived by the patient

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

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

  2. Pain perceived by the patient

    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.

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

  3. Disability

    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.

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Fernandez-Navarro R, Benito-de-Pedro M, Navarro Reyes FM, Moreno-Lopez J, Estebanez-Perez MJ, Pastora-Bernal JM. Intratissue percutaneous electrolysis and deep dry needling compared to a standard physiotherapy protocol in the treatment of whiplash syndrome: study protocol for a randomized controlled trial. Front Rehabil Sci. 2025 Nov 3;6:1670603. doi: 10.3389/fresc.2025.1670603. eCollection 2025. PubMed 41255411 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06938425
Lead sponsor
Camilo Jose Cela University
Responsible party
Rocío Fernández Navarro (Principal investigator, Camilo Jose Cela University) — Principal investigator
First posted
Apr 22, 2025
Start date
Nov 30, 2025 (estimated)
Primary completion
Jun 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Nov 26, 2025

Study contacts

Rocío Fernández Navarro
Contact
rocio.fnavarro@alumno.ucjc.edu
+34667201750
José M. Pérez Ortiz, PhD
Contact
josemanuel.perez@ucjc.edu
+34918153131
María Benito, PhD
study director · Associate Professor

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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