Clinical trial NCT05370092: Effect of Percutaneous Needle Electrolysis (PNE) on Tendinopathy
Official title: Effect of Percutaneous Needle Electrolysis on Tibialis Posterior Tendinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posterior Tibial Tendon Dysfunction
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: NUMERICAL SCALE OF PAIN (NSP)
timeFrame: 6 months
measure: FOOT AND ANKLE ABILITY (FAAM)
timeFrame: 6 months
measure: ULTRASOUND CONTROL
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Rey Juan Carlos
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Antonio Rejas Fernández
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Rey Juan Carlos
name: Jose Luis Arias Buría
role: STUDY_DIRECTOR
affiliation: Universidad Rey Juan Carlos
name: Ana Isabel De La Llave Rincón
role: STUDY_DIRECTOR
References:
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