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OpenTrials
Completed

NCT Number: NCT05680779

Neuromodulation in Chronic Ankle Instability

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physioterapy and Pain center research

Alcalá de Henares, Madrid, 28805, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ankle instability

Exclusion criteria

  • Subjects taking NSAIDs, analgesics or muscle relaxants
  • Epilepsy
  • Belonephobia or allergy to metals

Treatment and study plan

ultrasound-guided percutaneous neuromodulation

Other

It´s an intervention of physiotherapy

dry needling

Other

It´s an intervention of physiotherapy

Primary outcomes

  1. Cumberland ankle instability tool

    Time frame: Change from Baseline up to three months

    The Cumberland ankle instability tool (CAIT) is a questionnaire that consists of 9 items, the maximum score of the questionnaire is 30 points, the lower the score obtained, the more severe the functional instability of the ankle. The Spanish version of the CAIT has high internal consistency (Cronbach's α00.766) and reliability (intraclass correlation coefficient 0.979, 95 % confidence interval (CI) 0.958-0.990).

Secondary outcomes

  1. Byodex Balance System (BBS)

    Time frame: Change from Baseline up to 5 minutes

    The BBS is a platform designed to measure and record an individual´s ability to maintain stability under dynamic stress. It calculates a medial-lateral stability index (MLSI), anterior-posterior stability index (APSI), and an overall stability index (OSI) with reliability estimates of R= 0.92 (OSI), R = 0.89 (APSI), R= 0.93 (MLSI).

  2. Electromyography muscle (EMG)

    Time frame: Change from Baseline up to 5 minutes

    Mdurance EMG system is valid tool to measure muscle activity during isokinetic contractions. It has shown an almost perfect Intraclass Correlation Coefficient>0.81.

  3. stiffness tissue

    Time frame: Change from Baseline up to 5 minutes

    Myoton Pro is a device designed to measure and record Oscillation frequency (pitch), dynamic stiffness (stiffness), logarithmic decrement (elasticity), mechanical stress relaxation time and creep. It has shown an excellent reliability, Intraclass Correlation Coefficient 0.91-0.96 in all measures with the exception of elasticity 0.78-0.86

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

Ultrasound-guided Percutaneous Neuromodulation in Patiens With Chronic Ankle Instability

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 11, 2023
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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