Effect of Percutaneous Needle Electrolysis (PNE) on Tendinopathy

Not Applicable

Recruiting

• Conditions: Posterior Tibial Tendon Dysfunction

• Registration Number: NCT05370092
• Lead Sponsor: Universidad Rey Juan Carlos

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.

Study Timeline

• Study Start: 2022-03-20
• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-11
• Primary Completion: 2022-06-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
FOOT AND ANKLE ABILITY (FAAM)	6 months	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.
NUMERICAL SCALE OF PAIN (NSP)	6 months	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.
ULTRASOUND CONTROL	4 weeks	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.

Trial Locations

Locations (1)

Universidad Rey Juan Carlos; 🇪🇸 Madrid, Spain