Efficacy of Percutaneous Electrolysis in the Treatment of Achilles Tendinopathy

Official title

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

Overview

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.

Interventions

• 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
• 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

Primary outcome measures

• Victorian Institute of Sport Assessment - Achilles - Baseline [Time frame: Baseline]
• Victorian Institute of Sport Assessment - Achilles - Week 1 [Time frame: one week at study entry]
• Victorian Institute of Sport Assessment - Achilles - Week 2 [Time frame: two week at study entry]
• Victorian Institute of Sport Assessment - Achilles - Week 3 [Time frame: three week at study entry]
• Victorian Institute of Sport Assessment - Achilles - Week 4 [Time frame: four week at study entry]
• Victorian Institute of Sport Assessment - Achilles - Week 5 [Time frame: five week at study entry]
• Victorian Institute of Sport Assessment - Achilles - Week 6 [Time frame: six week at study entry]
• Victorian Institute of Sport Assessment - Achilles - Week 7 [Time frame: seven week at study entry]
• Victorian Institute of Sport Assessment - Achilles - Week 8 [Time frame: eight week at study entry]
• Victorian Institute of Sport Assessment - Achilles - Week 9 [Time frame: nine week at study entry]

Secondary outcome measures (12)

• visual analog scale - Baseline [Time frame: Baseline]
• visual analog scale - Week 1 [Time frame: one week at study entry]
• visual analog scale - Week 2 [Time frame: Two week at study entry]
• visual analog scale - Week 3 [Time frame: three week at study entry]
• visual analog scale - Week 4 [Time frame: four week at study entry]
• visual analog scale - Week 5 [Time frame: five week at study entry]
• visual analog scale - Week 6 [Time frame: six week at study entry]
• visual analog scale - Week 7 [Time frame: seven week at study entry]
• visual analog scale - Week 8 [Time frame: eight week at study entry]
• visual analog scale - Week 9 [Time frame: nine week at study entry]
• visual analog scale - Week 10 [Time frame: ten week at study entry]
• visual analog scale - Week 11 [Time frame: eleven week at study entry]

Eligibility criteria

Inclusion criteria

• Presence of symptoms in one or both Achilles tendons with a minimum duration of two months. In case the symptoms are bilateral, the intervention or placebo will only be administered and its results evaluated- in the limb with greater symptomatology. If it is not possible to differentiate which one presents greater pain, the right Achilles tendon will be chosen.
• Spontaneous pain of at least three points measured by a visual analog scale (VAS), reproducible by palpation between 2 and 6 cm above the insertion of the Achilles tendon in the calcaneal bone.
• Evidence of tendinopathy by MRI.
• Presence of post-static dyskinesia.
• Willingness to not perform additional treatments (such as footwear modifications, physical therapy, orthotics, injections, or surgery) for Achilles tendon pain during the conduct of the trial.
• Willingness to attempt to discontinue self-administration of medications (NSAIDs) for pain relief Achilles tendon(s) pain for at least 14 days prior to baseline assessment and during the course of the trial.

Exclusion criteria

• Presence or suspicion of pregnancy.
• Previous surgical intervention on the AT in the symptomatic leg(s)
• Total or partial rupture in the symptomatic AT
• Chronic ankle instability, in the foot with symptomatic tendon(s).
• Pathologies that can derive in pain in the region of the AT without being proper of the picture. (e.g.: osteoarthritis, impingement syndromes).
• Presence of arthritis or any metabolic or endocrine disorder (type 1 or 2 diabetes).
• Psychological disorders.
• Oncologic history.
• Treatment with quinolones or fluoroquinolones during the last two years.
• Treatment with statins for the control of hypercholesterolemia for more than two months
• Treatments within or at the periphery of the Achilles tendon, with anesthetics, corticosteroids or any other pharmacological agent during the last three months.
• Needle phobia
• Allergy to metal

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Argentina · 1 center

• Maimonides University — Buenos Aires

Identifiers

NCT: NCT05301959 · 5694

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗