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

NCT ID: NCT06938425

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-09-01

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.

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.

Conditions

Whiplash Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

standard physiotherapy treatment

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

Group Type: ACTIVE_COMPARATOR

Standard physiotherapy

Intervention Type: 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.

intratissue percutaneous electrolysis

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

Group Type: EXPERIMENTAL

intratissue percutaneous electrolysis

Intervention Type: 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

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

Group Type: EXPERIMENTAL

deep dry needling

Intervention Type: OTHER

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

Interventions

intratissue percutaneous electrolysis

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

Intervention Type: OTHER

deep dry needling

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

Intervention Type: OTHER

Standard 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Camilo Jose Cela University

OTHER

Sponsor Role: lead

Responsible Party

Rocío Fernández Navarro

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

María Benito, PhD

Role: STUDY_DIRECTOR

Associate Professor

Central Contacts

Rocío Fernández Navarro

Role: CONTACT

rocio.fnavarro@alumno.ucjc.edu

+34667201750

José M. Pérez Ortiz, PhD

Role: CONTACT

josemanuel.perez@ucjc.edu

+34918153131

References

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.

Reference Type: DERIVED

PMID: 41255411 (View on PubMed)

Other Identifiers

16_23_FINER

Identifier Type: -

Identifier Source: org_study_id