Neuromodulation in Chronic Ankle Instability

Ankle Sprains Clinical Trial

Official title:

Ultrasound-guided Percutaneous Neuromodulation in Patiens With Chronic Ankle Instability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05680779
• Other study ID #: CEID/2022/2/031
• Status: Completed
• Phase: N/A
• Start date: July 23, 2023
• Est. completion date: May 2, 2024

Study information

• Verified date: May 2024
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2, 2024
• Est. primary completion date: May 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Ankle instability

Exclusion Criteria:

• Subjects taking NSAIDs, analgesics or muscle relaxants

• Epilepsy

• Belonephobia or allergy to metals

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains

Intervention

Other:
• ultrasound-guided percutaneous neuromodulation
It´s an intervention of physiotherapy
• dry needling
It´s an intervention of physiotherapy

Locations

Country	Name	City	State
Spain	Physioterapy and Pain center research	Alcalá de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumberland ankle instability tool	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 a00.766) and reliability (intraclass correlation coefficient 0.979, 95 % confidence interval (CI) 0.958-0.990).	Change from Baseline up to three months
Secondary	Byodex Balance System (BBS)	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).	Change from Baseline up to 5 minutes
Secondary	Electromyography muscle (EMG)	Mdurance EMG system is valid tool to measure muscle activity during isokinetic contractions. It has shown an almost perfect Intraclass Correlation Coefficient>0.81.	Change from Baseline up to 5 minutes
Secondary	stiffness tissue	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	Change from Baseline up to 5 minutes