Whiplash InjuriesNCT06938425
Effectiveness of Percutaneous Electrolysis and Dry Needling vs. Standard Therapy for Whiplash Syndrome
A study testing intratissue percutaneous electrolysis, deep dry needling and Standard physiotherapy in people with Whiplash Injuries, run by Camilo Jose Cela University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Whiplash Injuries
- What is being tested?
- intratissue percutaneous electrolysis, deep dry needling and Standard physiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Conditions
- Whiplash Injuries
- Being tested
- intratissue percutaneous electrolysis, deep dry needling, Standard physiotherapy
- Keywords
- Percutaneous electrolysis, Dry needling, Whiplash, Myofascial pain syndrome, Myofascial trigger point, Intrafibrillar blood flow, elasticity
- Medical subject headings
- Whiplash Injuries, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intratissue percutaneous electrolysisOther
Using fine needles guided by ultrasound to apply electrical stimulation directly to the affected tissue (for example, damaged muscles or tendons).
deep dry needlingOther
Insertion of fine needles into muscle trigger points (without injection of drugs) to relieve muscle pain and release tension.
Standard physiotherapyProcedure or surgery
It includes manual techniques such as therapeutic massage and mobilization, along with stretching and strengthening exercises to improve range of motion and reduce pain.
| Study group | Role | What they receive |
|---|---|---|
| standard physiotherapy treatment | Active comparator | Participants in this group will receive standard physical therapy sessions, including manual techniques, massage therapy and mobility exercises. Receives: Procedure: Standard physiotherapy |
| intratissue percutaneous electrolysis | Experimental | Participants in this group will receive physiotherapy sessions using the Percutaneous Intratisular Electrolysis (EPI) technique, Receives: 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. Receives: Other: deep dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
Pain is a quantitative variable. The investigators will use the numerical evaluation scale (EN), which consists of a numbered scale from 1 -10.
Measured: From the beginning of treatment to the end of treatment at 4 weeks and at 3 months
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.
Measured: From the beginning of treatment to the end of treatment at 4 weeks and at 3 months
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.
Measured: From the beginning of treatment to the end of treatment at 4 weeks and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start30 Nov 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Whiplash InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Camilo Jose Cela University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocío Fernández Navarro, Camilo Jose Cela University
- Investigators
- María Benito, PhD, Study director, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938425
- Sponsor's protocol ID
- 16_23_FINER
- Status last verified
- Nov 2025
- First submitted
- 3 Feb 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06938425
- Acronym / sponsor ID
- 16_23_FINER
- Conditions
- Whiplash Injuries
- Keywords
- Percutaneous electrolysis, Dry needling, Whiplash, Myofascial pain syndrome, Myofascial trigger point, Intrafibrillar blood flow, elasticity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Camilo Jose Cela UniversityUniversity, hospital or other
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard physiotherapy treatment | Active comparator | Procedure: Standard physiotherapyParticipants in this group will receive standard physical therapy sessions, including manual techniques, massage therapy and mobility exercises. |
| intratissue percutaneous electrolysis | Experimental | Other: intratissue percutaneous electrolysisParticipants in this group will receive physiotherapy sessions using the Percutaneous Intratisular Electrolysis (EPI) technique, |
| Deep Dry needling | Experimental | Other: deep dry needlingParticipants in this group will receive physiotherapy sessions using the dry puncture technique applied to active trigger points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intratissue percutaneous electrolysisUsing fine needles guided by ultrasound to apply electrical stimulation directly to the affected tissue (for example, damaged muscles or tendons). | Other | intratissue percutaneous electrolysis |
| deep dry needlingInsertion of fine needles into muscle trigger points (without injection of drugs) to relieve muscle pain and release tension. | Other | Deep Dry needling |
| Standard physiotherapyIt includes manual techniques such as therapeutic massage and mobilization, along with stretching and strengthening exercises to improve range of motion and reduce pain. | Procedure or surgery | standard physiotherapy treatment |
Primary outcome
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).
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).
3 secondary outcomes
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 perceived by the patient
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Derived from this study: PubMed 41255411Fernandez-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.
Related trials for Whiplash Injuries
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StressModex for Post-Traumatic Neck Pain
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Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders
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Virtual Reality Rehabilitation in Neck Pain Subjects
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
María Benito, PhD study director
Associate Professor
Questions about this trial
What is this clinical trial studying?
A study testing intratissue percutaneous electrolysis, deep dry needling and Standard physiotherapy in people with Whiplash Injuries, run by Camilo Jose Cela University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rocío Fernández Navarro (+34667201750, rocio.fnavarro@alumno.ucjc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrafibrillar blood flow (time frame: From the beginning of treatment to the end of treatment at 4 weeks and at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06938425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.