Neuromodulation in Chronic Ankle Instability

Sponsor
University of Alcala (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05680779
Collaborator
(none)
54
1
2
8
6.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: ultrasound-guided percutaneous neuromodulation
  • Other: dry needling
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ultrasound-guided Percutaneous Neuromodulation in Patiens With Chronic Ankle Instability
Anticipated Study Start Date :
Jan 15, 2023
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Sep 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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)

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

Other: 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.

Other: dry needling
It´s an intervention of physiotherapy

Outcome Measures

Primary Outcome Measures

  1. Cumberland ankle instability tool [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 Outcome Measures

  1. Byodex Balance System (BBS) [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) [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Ankle instability
Exclusion Criteria:
  • Subjects taking NSAIDs, analgesics or muscle relaxants

  • Epilepsy

  • Belonephobia or allergy to metals

Contacts and Locations

Locations

Site City State Country Postal Code
1 Physioterapy and Pain center research Alcalá de Henares Madrid Spain 28805

Sponsors and Collaborators

  • University of Alcala

Investigators

  • Study Chair: Daniel Pecos-Martin, PhD, Alcala University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Dr. Daniel Pecos Martín, PhD Daniel Pecos-Martin, University of Alcala
ClinicalTrials.gov Identifier:
NCT05680779
Other Study ID Numbers:
  • CEID/2022/2/031
First Posted:
Jan 11, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2023