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

November 25, 2025 updated by: Rocío Fernández Navarro, Camilo Jose Cela University

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard physiotherapy treatment
Participants in this group will receive standard physical therapy sessions, including manual techniques, massage therapy and mobility exercises.
It includes manual techniques such as therapeutic massage and mobilization, along with stretching and strengthening exercises to improve range of motion and reduce pain.
Experimental: intratissue percutaneous electrolysis
Participants in this group will receive physiotherapy sessions using the Percutaneous Intratisular Electrolysis (EPI) technique,
Using fine needles guided by ultrasound to apply electrical stimulation directly to the affected tissue (for example, damaged muscles or tendons).
Experimental: Deep Dry needling
Participants in this group will receive physiotherapy sessions using the dry puncture technique applied to active trigger points.
Insertion of fine needles into muscle trigger points (without injection of drugs) to relieve muscle pain and release tension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From the beginning of treatment to the end of treatment at 4 weeks and at 3 months
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).
From the beginning of treatment to the end of treatment at 4 weeks and at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the beginning of treatment to the end of treatment at 4 weeks and at 3 months
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.
From the beginning of treatment to the end of treatment at 4 weeks and at 3 months
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.
From the beginning of treatment to the end of treatment at 4 weeks and at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: María Benito, PhD, Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Whiplash Injuries

Clinical Trials on Standard physiotherapy

Subscribe