About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

low intensity percutaneous musculoskeletal electrolysis
Device
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.
Sham application
Device
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.
Silbernagel protocol
Other intervention
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.

Treatment groups

102 Participants

are divided into 2 treatment groups

Group A: Experimental groupExperimental treatment 2 interventions

Group B: Simulated group.Sham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Victorian Institute of Sport Assessment - Achilles - Baseline

patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

Time frame

Baseline

2

Victorian Institute of Sport Assessment - Achilles - Week 1

patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

Time frame

one week at study entry

3

Victorian Institute of Sport Assessment - Achilles - Week 2

patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

Time frame

two week at study entry

4

Victorian Institute of Sport Assessment - Achilles - Week 3

patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).

Time frame

three week at study entry

Secondary outcomes

1

visual analog scale - Baseline

The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).

Time frame

Baseline

2

visual analog scale - Week 1

The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).

Time frame

one week at study entry

3

visual analog scale - Week 2

The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).

Time frame

Two week at study entry

4

visual analog scale - Week 3

The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).

Time frame

three week at study entry

Efficacy of Percutaneous Electrolysis in the Treatment of Achilles Tendinopathy

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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