intratissue percutaneous electrolysis
OtherUsing fine needles guided by ultrasound to apply electrical stimulation directly to the affected tissue (for example, damaged muscles or tendons).
NCT Number: NCT06938425
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Using fine needles guided by ultrasound to apply electrical stimulation directly to the affected tissue (for example, damaged muscles or tendons).
Insertion of fine needles into muscle trigger points (without injection of drugs) to relieve muscle pain and release tension.
It includes manual techniques such as therapeutic massage and mobilization, along with stretching and strengthening exercises to improve range of motion and reduce pain.
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).
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).
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.
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.
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.
Contact information is provided by the study sponsor or research team.
José M. Pérez Ortiz, PhD
CONTACT
Rocío Fernández Navarro
CONTACT
Camilo Jose Cela University
Other
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
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