Effect of Percutaneous Needle Electrolysis (PNE) on Tendinopathy

Universidad Rey Juan Carlos

Status: Completed

Conditions: Posterior Tibial Tendon Dysfunction

Treatments: Other: Percutaneous needle electrolysis; Other: Therapeutic exercise; Other: Manual therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05370092

1801202201622

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 months
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Other: Manual therapy

Other: Therapeutic exercise

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Manual therapy

Other: Therapeutic exercise

Other: Percutaneous needle electrolysis