Effect of Percutaneous Needle Electrolysis (PNE) on Tendinopathy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to test the efficacy of percutaneous electrolysis in posterior tibial tendinopathies. The posterior tibial tendon injury is one of the most frequent pathologies in the lower extremities, and therefore a correct study and evaluation of it is necessary. This study aims to compare the therapeutic effect of percutaneous electrolysis comparing a control group with an experimental group. To evaluate functionality, pain and its ultrasound pattern before and after treatment, in order to assess the efficacy of the treatment.

Detailed Description
-----------------
A single-blind, longitudinal, randomised, controlled, single-blind, longitudinal, randomised, controlled clinical trial will be conducted. First, the participant will receive a FOOT AND ANKLE ABILITY (FAAM) survey, along with a numerical pain scale, both of which must be completed. Next, an ultrasound study of the foot will be performed, focusing on pain in the inner ankle, to check for possible pathology in the posterior tibial tendon. Finally, the physiotherapist's intervention will be carried out to check the effectiveness of the technique, which may cause some pain, and finally, the numerical pain scale will be passed again. Four sessions will be carried out in four different weeks, always using the same day of the week for the intervention and following the same steps as above. The purpose of this study is to test the efficacy of PD in posterior tibial tendinopathy and whether PD is therefore a safe technique for this type of intervention. All patients will sign an informed consent form and will be informed about the study beforehand.

Official Title
-----------------
Effect of Percutaneous Needle Electrolysis on Tibialis Posterior Tendinopathy

Conditions
-----------------
Posterior Tibial Tendon Dysfunction

Intervention / Treatment
-----------------
* Other: Percutaneous needle electrolysis
* Other: Therapeutic exercise
* Other: Manual therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects over 18 years of age Mild inflammation, swelling and/or tenderness posterior to the medial malleolus Pain posterior and/or superior to the medial malleolus, aggravated by activity Pain present for at least 3 weeks One or more signs of flexible flatfoot deformity, including excessive valgus deformity of the hindfoot during weight bearing and/or excessive foot abduction (many toes sign). Pain when performing the Hell Rise Test or performed incorrectly. Signs of tenosynovitis on ultrasound examination. As the inclusion criteria are based on side-to-side comparison all participants had to have unilateral involvement. Exclusion Criteria: Previous surgery on the affected foot, leg or knee. Disabling osteoarthritis of the knee on the affected side. Fixed hindfoot deformities. Recurrent ankle sprains on the affected side. Ligament tears or bony abnormalities of the affected foot. A physical or medical condition that contraindicates the testing protocol. Pregnancy. FCD or FLH tendinopathy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Patients assigned to this group will receive a session of manual therapy and therapeutic exercise. The manual therapy (TM) treatment for tendinopathies is mainly focused on soft tissue mobilization and deep transverse friction massage (Cyriax). The therapeutic exercise session participants will perform 2 exercises for 4 weeks 3 days per week. The first exercise they will perform will be the Short-Foot Exercise holding the position 5 seconds isometrically. The second exercise will be plantar flexion of the ankle with adduction of the foot and inversion with elastic band in its concentric and eccentric phase. Each exercise will be performed in 3 series of 15 repetitions, with 1 minute rest between series, the exercise session will follow the TM and will last approximately 15-20 minutes. | Other: Therapeutic exercise<br>* The first exercise they will perform will be the Short-Foot Exercise holding the position 5 seconds isometrically. The second exercise will be plantar flexion of the ankle with adduction of the foot and inversion with elastic band in its concentric and eccentric phase<br>Other: Manual therapy<br>* The manual therapy (TM) treatment for tendinopathies is mainly focused on soft tissue mobilization and deep transverse friction massage (Cyriax).<br>|
| Experimental: Intervention group<br>Participants in this group will receive 4 sessions (once a week during their respective treatment session) of percutaneous electrolysis guided by MUSCULO-SKELETAL ECOGRAPHY, by a physiotherapist with extensive clinical experience in this therapeutic approach. The technique will be applied using a specifically developed and medically certified device (EPI Advanced Medicine®, Barcelona, Spain. EPI®). The galvanic current will be applied using acupuncture needles. In the present study, a 0.30*25 mm needle (Agupunt, Barcelona, Spain) will be used, with an intensity of 2 mA for a total of 3-5 seconds and 3-5 impacts on the liquid content (TTP tenosynovitis) and 2 mA for a total of 3 seconds and 2-3 impacts if in the tendon (intrasubstance). The technique shall be applied under ultrasound guidance. The needle shall be introduced at an angle of 80° in a short-axis cross-section to the skin, with the tip of the needle directed towards the posterior tibial tendon. | Other: Percutaneous needle electrolysis<br>* Electrolysis is the process by which water (H2O) and sodium chloride (NaCl) molecules, which are present in the biological tissues and body compartments of our organism, are organically broken down into their constituent chemical elements, regrouping to create entirely new substances such as sodium hydroxide (NaOH), hydrogen gas (H2) and chlorine gas (Cl2). This process occurs thanks to the passage of a flow of direct electric current, also known as galvanic current, which is a totally athermal process. The passage of this current allows a local inflammatory response to occur (increase in lymphocytes and macrophages) as well as an increase in vasodilatation, inducing phagocytosis and biological stimulation of tendon repair.<br>Other: Therapeutic exercise<br>* The first exercise they will perform will be the Short-Foot Exercise holding the position 5 seconds isometrically. The second exercise will be plantar flexion of the ankle with adduction of the foot and inversion with elastic band in its concentric and eccentric phase<br>Other: Manual therapy<br>* The manual therapy (TM) treatment for tendinopathies is mainly focused on soft tissue mobilization and deep transverse friction massage (Cyriax).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NUMERICAL SCALE OF PAIN (NSP) | The scale consists of a horizontal line of 11 numbers, at the ends of which are the extreme manifestations of a symptom that allows observers to measure the intensity of pain with maximum reproducibility. On the far left is 0 or the total absence of pain and on the far right is 10 or the maximum pain that can be tolerated. The patient will be asked to select the number where they consider their pain to be. The objective of the scale is to reduce the patient's pain with the intervention and that the pain that he gives us at the beginning, prior to the intervention, decreases until it reaches 0. | 6 months | 
| FOOT AND ANKLE ABILITY (FAAM) | The FAAM questionnaire consists of 29 items separated into two subscales: the ADL subscale with 21 items and the Sport subscale with 8 items. Each one has a maximum Likert scale score of 5 points ranging from no difficulty to impossible to perform. All scores will be converted to percentages, with a higher percentage indicating a higher level of functionality and lower pathology. At the end of the scale, the functionality percentage will be calculated, ranging from 0% (inability to perform any activity) to 100% (normal functionality level). Finally, patients will rate the condition of their ankle and foot on a 4-point scale that includes normal, almost normal, abnormal, and severely abnormal. The intention of the study is that the patient recovers 100% of functionality or better the percentage that has been marked prior to the intervention. As in the 4-point scale, the condition of your ankle should be normal. | 6 months | 
| ULTRASOUND CONTROL | All participants, both in the control and experimental groups, will be examined before the intervention and at the end of the 4 sessions to evaluate possible changes in the tendon, and all invasive interventions will be performed ultrasonographically. We will take as reference the pre-intervention measurement in millimeters and the post-intervention measurement to see if the tendon has undergone changes in its size. | 4 weeks |