Neuromodulation in Chronic Ankle Instability

NCT05680779 | Completed

• 1 other identifier: CEID/2022/2/031
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Sprains

Outcome Measures

Primary Outcomes (1)

• 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 α00.766) and reliability (intraclass correlation coefficient 0.979, 95 % confidence interval (CI) 0.958-0.990).

  Change from Baseline up to three months

Secondary Outcomes (3)

• Byodex Balance System (BBS)

  Change from Baseline up to 5 minutes

• Electromyography muscle (EMG)

  Change from Baseline up to 5 minutes

• stiffness tissue

  Change from Baseline up to 5 minutes

Study Arms (2)

PNM group

EXPERIMENTAL

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

Control group

OTHER

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

Interventions

ultrasound-guided percutaneous neuromodulation OTHER

It´s an intervention of physiotherapy

PNM group

dry needling OTHER

It´s an intervention of physiotherapy

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ankle instability

You may not qualify if:

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

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Physioterapy and Pain center research

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Daniel Pecos-Martin, PhD

  Alcala University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Daniel Pecos-Martin

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 11, 2023
• Study Start: July 23, 2023
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

ES (1)