Neuromodulation in Chronic Ankle Instability

NCT ID: NCT05680779

Last Updated: 2024-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-23

Study Completion Date

2024-05-02

Brief Summary

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Ankle sprain is a common injury. Around 712,000 sprains occur every day in the world. It is estimated that they account for 45% of sports injuries, being the second part of the body that is most frequently injured in sports. Of the patients who suffer this injury, around 70% will develop chronic ankle instability, a situation that can cause residual pain, recurrent sprains, a feeling of lack of stability and decreased physical activity.

Two entities can be included in chronic ankle instability: mechanical instability, which involves movement of the joint beyond its physiological limit, and functional instability, which includes proprioceptive dysfunction, impaired neuromuscular control, postural control, and strength deficits.

Currently, the conservative treatment of these patients consists of neuromuscular training through the use of dynamic balance platforms, taping, joint mobilization, dry needling, and the use of plantar supports, balance training being the one that has shown the best result.

Ultrasound-guided percutaneous neuromodulation (PNM) is a recently used technique in the field of invasive physiotherapy that consists of applying a square wave biphasic electrical current through an acupuncture needle-like electrode that is place in close proximity to the nerve with ultrasound guidance. The aim of this study is to evaluate the effectiveness of PNM in ankle instability.

Detailed Description

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Conditions

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Ankle Sprains

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PNM group

Subjects were treated once time. The technique consisted in the application of a square wave biphasic electrical current, with 10 Hz frequency, with 250 μs pulse width and the maximal torelable intensity to cause an exacerbated muscle contraction during ten seconds with a rest period of another ten seconds y total number of ten times. The subjects were lying in lateral decubitus. The common peroneal nerve was located with ultrasound (cross section) near to the peroneal head. After, an acupuncture needle (0,30mm x 30mm) was inserted in a long axis approach until the perineurium of the common peroneal nerve (in close proximity)

Group Type EXPERIMENTAL

ultrasound-guided percutaneous neuromodulation

Intervention Type OTHER

It´s an intervention of physiotherapy

Control group

Subjects were treated once time. The subjects were lying in lateral decubitus. The common peroneal nerve was located with ultrasound (cross section) near to the peroneal head. After, an acupuncture needle (0,30mm x 30mm) was inserted in a long axis approach until the perineurium of the common peroneal nerve (in close proximity). The needle remains in this location during 200 seconds without any electrical current.

Group Type OTHER

dry needling

Intervention Type OTHER

It´s an intervention of physiotherapy

Interventions

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ultrasound-guided percutaneous neuromodulation

It´s an intervention of physiotherapy

Intervention Type OTHER

dry needling

It´s an intervention of physiotherapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ankle instability

Exclusion Criteria

* Subjects taking NSAIDs, analgesics or muscle relaxants
* Epilepsy
* Belonephobia or allergy to metals
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Daniel Pecos Martín

PhD Daniel Pecos-Martin

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Pecos-Martin, PhD

Role: STUDY_CHAIR

Alcala University

Locations

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Physioterapy and Pain center research

Alcalá de Henares, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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CEID/2022/2/031

Identifier Type: -

Identifier Source: org_study_id

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