NCT06938425

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Nov 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Nov 2025Sep 2026

First Submitted

Initial submission to the registry

February 3, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

November 30, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

February 3, 2025

Last Update Submit

November 25, 2025

Conditions

Keywords

Percutaneous electrolysisDry needlingWhiplashMyofascial pain syndromeMyofascial trigger pointIntrafibrillar blood flowelasticity

Outcome Measures

Primary Outcomes (2)

  • 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).

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

  • 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).

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

Secondary Outcomes (3)

  • Pain perceived by the patient

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

  • Pain perceived by the patient

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

  • Disability

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

Study Arms (3)

standard physiotherapy treatment

ACTIVE COMPARATOR

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

Procedure: Standard physiotherapy

intratissue percutaneous electrolysis

EXPERIMENTAL

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

Other: intratissue percutaneous electrolysis

Deep Dry needling

EXPERIMENTAL

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

Other: deep dry needling

Interventions

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

intratissue percutaneous electrolysis

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

Deep Dry needling

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

standard physiotherapy treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Whiplash InjuriesMyofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and InjuriesMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • María Benito, PhD

    Associate Professor

    STUDY DIRECTOR

Central Study Contacts

Rocío Fernández Navarro

CONTACT

José M. Pérez Ortiz, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 3, 2025

First Posted

April 22, 2025

Study Start

November 30, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

November 26, 2025

Record last verified: 2025-11