NCT05301959

Efficacy of Percutaneous Electrolysis in the Treatment of Achilles Tendinopathy

Evaluation of the Efficacy of Adding Low-intensity Percutaneous Musculoskeletal Electrolysis to the Conservative Treatment of Noninsertional Achilles Tendinopathy: a Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Maimonides University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Achilles tendinopathy (AT) is one of the most reported myotendinous pathologies due to overuse in the literature. In the general adult population, its incidence is 2.35 cases per 1,000 patients, with no difference between men and women. The international literature reports that up to 29% of patients fail with conservative treatment. Within physiotherapy, new alternatives for the treatment of tendinopathies arise, applying electric currents percutaneously, which from a mechanical effect associated to the use of a needle and an electric effect by the use of galvanic currents, generate a local inflammatory response; activation of the central nervous system and analgesia. The aim of the research is to evaluate the efficacy of adding low intensity percutaneous electrolysis to the treatment with a high load eccentric exercise program based on the protocol of Silbernagel et al. in adults with Achilles tendinopathy to improve its functionality. A randomized, double-blind, blinded, evaluator-blinded, controlled clinical trial will be conducted in parallel groups (experimental treatment vs. sham treatment), with a follow-up at 26 and 52 weeks after the first intervention. Non-probability and intentional sampling will be performed.

Conditions

• Achilles Tendinopathy

Interventions

Type	Name	Description
DEVICE	low intensity percutaneous musculoskeletal electrolysis	An acupuncture needle (0.30mm X 25mm) will be introduced into the device's strut. With the equipment on and with a base intensity of 120µA, the acupuncture needle is introduced in a proximal-distal and postero-anterior direction, in the area of the Achilles tendon body. The position of the needle will be checked with ultrasound and once the point to be treated is reached, the working intensity will be increased up to 600 µA. The emission will be maintained until the participant reports a pain of 60/100 in VAS. At that moment, the emission will be paused completely until the participant reports a sensation of at least 20/100 in VAS. After this period the emission will be continued at 600 µA. This cycle will continue until the emission lasts for more than 120 sec, continuously. At this point, the needle will be repositioned to repeat the emission protocol a maximum of 3 times in total.
DEVICE	Sham application	A modification will be made in a second equipment, closing the circuit with a 10kΩ resistor inside the equipment, in the output strand chip. Allowing the simulation of emission without emitting current to the participant and without being able to appreciate any type of alteration in the handling of the equipment, by the operators. Therefore, the same steps will be followed as in the experimental group.
OTHER	Silbernagel protocol	The Silbernagel et al. protocol comprises several heel raising exercises with concentric and eccentric movements, performed on two legs and one leg. It is composed of 3 sets of 15 repetitions and that during the exercises allows pain to be present, but not being disabling. The exercises will be performed only once a day. The progression will be made by changing from standing exercises to monopodal support, moving from concentric-eccentric to purely eccentric loading, adding weight in a backpack (in steps of 5 kg when pain does not exceed 5 in the pain monitoring model) and finally using fast rebound exercises and plyometric exercises.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2022-03-31
• Last updated: 2023-08-01

Locations

1 site across 1 country: Argentina