Clinical trial NCT05301959: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Achilles Tendinopathy
Keywords: tendinopathy
physiotherapy
percutaneous electrolysis
Lead sponsor: Maimonides University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Victorian Institute of Sport Assessment - Achilles - Baseline
timeFrame: Baseline
measure: Victorian Institute of Sport Assessment - Achilles - Week 1
timeFrame: one week at study entry
measure: Victorian Institute of Sport Assessment - Achilles - Week 2
timeFrame: two week at study entry
measure: Victorian Institute of Sport Assessment - Achilles - Week 3
timeFrame: three week at study entry
measure: Victorian Institute of Sport Assessment - Achilles - Week 4
timeFrame: four week at study entry
measure: Victorian Institute of Sport Assessment - Achilles - Week 5
timeFrame: five week at study entry
measure: Victorian Institute of Sport Assessment - Achilles - Week 6
timeFrame: six week at study entry
measure: Victorian Institute of Sport Assessment - Achilles - Week 7
timeFrame: seven week at study entry
measure: Victorian Institute of Sport Assessment - Achilles - Week 8
timeFrame: eight week at study entry
measure: Victorian Institute of Sport Assessment - Achilles - Week 9
timeFrame: nine week at study entry
measure: Victorian Institute of Sport Assessment - Achilles - Week 10
timeFrame: ten week at study entry
measure: Victorian Institute of Sport Assessment - Achilles - Week 11
timeFrame: eleven week at study entry
measure: Victorian Institute of Sport Assessment - Achilles - Week 12
timeFrame: twelve week at study entry
measure: Victorian Institute of Sport Assessment - Achilles - Week 26
timeFrame: twenty-six week at study entry
measure: Victorian Institute of Sport Assessment - Achilles - Week 52
timeFrame: fifty-two week at study entry
Secondary outcomes:
measure: visual analog scale - Baseline
timeFrame: Baseline
measure: visual analog scale - Week 1
timeFrame: one week at study entry
measure: visual analog scale - Week 2
timeFrame: Two week at study entry
measure: visual analog scale - Week 3
timeFrame: three week at study entry
measure: visual analog scale - Week 4
timeFrame: four week at study entry
measure: visual analog scale - Week 5
timeFrame: five week at study entry
measure: visual analog scale - Week 6
timeFrame: six week at study entry
measure: visual analog scale - Week 7
timeFrame: seven week at study entry
measure: visual analog scale - Week 8
timeFrame: eight week at study entry
measure: visual analog scale - Week 9
timeFrame: nine week at study entry
measure: visual analog scale - Week 10
timeFrame: ten week at study entry
measure: visual analog scale - Week 11
timeFrame: eleven week at study entry
measure: visual analog scale - Week 12
timeFrame: twelve week at study entry
measure: visual analog scale - Week 26
timeFrame: twenty-six week at study entry
measure: visual analog scale - Week 52
timeFrame: fifty-two week at study entry
measure: The Foot and Ankle Ability Measure - Baseline
timeFrame: Baseline
measure: The Foot and Ankle Ability Measure - Week 1
timeFrame: one week at study entry
measure: The Foot and Ankle Ability Measure - Week 2
timeFrame: two week at study entry
measure: The Foot and Ankle Ability Measure - Week 3
timeFrame: three week at study entry
measure: The Foot and Ankle Ability Measure - Week 4
timeFrame: four week at study entry
measure: The Foot and Ankle Ability Measure - Week 5
timeFrame: five week at study entry
measure: The Foot and Ankle Ability Measure - Week 6
timeFrame: six week at study entry
measure: The Foot and Ankle Ability Measure - Week 7
timeFrame: seven week at study entry
measure: The Foot and Ankle Ability Measure - Week 8
timeFrame: eight week at study entry
measure: The Foot and Ankle Ability Measure - Week 9
timeFrame: nine week at study entry
measure: The Foot and Ankle Ability Measure - Week 10
timeFrame: ten week at study entry
measure: The Foot and Ankle Ability Measure - Week 11
timeFrame: eleven week at study entry
measure: The Foot and Ankle Ability Measure - Week 12
timeFrame: twelve week at study entry
measure: The Foot and Ankle Ability Measure - Week 26
timeFrame: twenty-six week at study entry
measure: The Foot and Ankle Ability Measure - Week 52
timeFrame: fifty-two week at study entry
measure: ultrasound Shear Wave elastography - baseline
timeFrame: Baseline
measure: ultrasound Shear Wave elastography - Week 4
timeFrame: four week at study entry
measure: ultrasound Shear Wave elastography - Week 8
timeFrame: eight week at study entry
measure: ultrasound Shear Wave elastography - Week 12
timeFrame: twelve week at study entry
measure: ultrasound Shear Wave elastography - Week 26
timeFrame: twenty-six week at study entry
measure: ultrasound Shear Wave elastography - Week 52
timeFrame: fifty-two week at study entry
measure: Vienna Achilles tendon morphological score - MRI - baseline
timeFrame: Baseline
measure: Vienna Achilles tendon morphological score - MRI - Week 4
timeFrame: four week at study entry
measure: Vienna Achilles tendon morphological score - MRI - Week 8
timeFrame: eight week at study entry
measure: Vienna Achilles tendon morphological score - MRI - Week 12
timeFrame: twelve week at study entry
measure: Vienna Achilles tendon morphological score - MRI - Week 26
timeFrame: twenty-six week at study entry
measure: Vienna Achilles tendon morphological score - MRI - Week 52
timeFrame: fifty-two week at study entry
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Maimonides University
state: Caba
Study officials:
affiliation: Maimonides University
name: Santiago M d'Almeida, PT SCS
role: PRINCIPAL_INVESTIGATOR
References: