None listed
Conditions
Brief summary
Plantar fasciosis is a chronic degenerative process of the plantar fascia. Etiology is not entirely known; is argued that can be caused by repetitive microtrauma. The typical symptom is plantar medial heel pain, which is more noticeable with initial steps after a period of inactivity and continues to deteriorate after prolonged weight bearing (Neufeld, 2007). The current histological findings published on plantar fasciitis support the nonexistence of inflammatory mediators; show a myxoid tissue degeneration, loss of fiber orientation, collagen necrosis and angiofybroblastic hyperplasia. These characteristics are related to degenerative processes without inflammation of the fascia or plantar fasciosis (Lemont, 2003). Scientific evidence of conservative management of individuals with plantar fasciosis is sometimes conflicting. There is evidence that regular exercise programs are effective for this pain condition. The inclusion of other therapeutic modalities is still controversial. In acute stages, therapeutic medical invasive treatments as glucocorticoids infiltrations counters inflammation. On the other hand, in chronic stages we can induce this inflammation by applying a galvanic low-current through an acupuncture needle, in order to induce a local process of electrolysis.The chemical reaction that takes place under the cathode produces changes in the damaged tissue by the formation of an alkaline controlled burn in the extracellular medium. This leads to an inflammatory response and tissue ablation, restarting the regenerative process. The destroyed tissue is metabolized by the body itself through phagocytosis (Martínez Morillo M, 1998; Martin Cordero JE, 2008). The Therapeutic Percutaneous Electrolysis device (EPTE Registered Trademark System; EPTE Manual, 2014 IONCLINICS & DEIONIC, SL) is a tool that enables to access to the soft tissue dysfunction and apply a local treatment that involves a galvanic current through an acupuncture needle with high accuracy, since the treatment is performed with an ultrasound device. The EPTE device (Registered Trademark) has proven its effectivity in the treatment of tendonitis (Arias, 2015) and we hypothesize that it could also be effective in other connective tissue of different density, and with similarities in pathophysiology and histopathology, as the plantar fascia is. Therefore, the proposal of this research is to evaluate the efficacy of the Ultrasound-guided Percutaneous Electrolysis treatment, in the degenerated plantar fasiosis, versus patients which only receive a placebo treatment.
Interventions
Experimental: US-guided percutaneous electrolysis
Patients will receive one weekly session for 5 weeks for 5 weeks of US-guided percutaneous electrolysis. This intervention consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the plantar fascia insertion.
Treatment will be applied by Physical Therapist/Medical Doctor with minimum 5 years of experience in ultrasound-guided invasive techniques.
Dosage: 350 microamperes (28 mic
Experimental: US-guided percutaneous electrolysis Patients will receive one weekly session for 5 weeks for 5 weeks of US-guided percutaneous electrolysis. This intervention consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the plantar fascia insertion. Treatment will be applied by Physical Therapist/Medical Doctor with minimum 5 years of experience in ultrasound-guided invasive techniques. Dosage: 350 microamperes (28 microcoulombs) Duration: 3 approaches of 80 second each one inside the plantar fascia insertion, on the same visit, once per week Mode: Percutaneous Galvanic Device: EPTE device (Registered Trademark). Max 48 Volts, 1000 microamps. Ultrasound Device: Mindray (Registered Trademark) M7 ultrasound system with linear L12-4s transducer Adherence monitoring: Not applicable
Sponsors
Camilo Jose Cela University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Insidious onset of sharp pain under the plantar heel surface upon weight bearing after a period of non-weight bearing. Plantar heel pain which increases in the morning with the first steps after waking up. Symptoms decreasing with slight levels of activity, such as walking. Plantar fascia ultrasound thickness greater than 0,4 cm.
Exclusion criteria
Prior surgery in the lower extremity. Diagnosis of fibromyalgia syndrome. Previous physical therapy interventions for the foot region in the previous 6 months. Lidocaine or other injections in the plantar fascia for the management of pain in the previous 6 months.
Outcome results
None listed