## Protocol Section
### Identification Module
**NCT ID:** NCT05680779

**Brief Title:** Neuromodulation in Chronic Ankle Instability

**Official Title:** Ultrasound-guided Percutaneous Neuromodulation in Patiens With Chronic Ankle Instability

#### Organization Study ID Info
**ID:** CEID/2022/2/031
#### Organization
**Class:** OTHER
**Full Name:** University of Alcala
### Status Module
#### Completion Date
**Date:** 2024-05-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-03

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-05-02

**Type:** ACTUAL

#### Start Date
**Date:** 2023-07-23

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2023-01-11
**Type:** ACTUAL
**Study First Submit Date:** 2022-12-23
**Study First Submit QC Date:** 2022-12-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Alcala

#### Responsible Party

**Investigator Affiliation:** University of Alcala

**Investigator Full Name:** Prof. Dr. Daniel Pecos Martín

**Investigator Title:** PhD Daniel Pecos-Martin

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Ankle Sprains

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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)

**Intervention Names:**

- Other: ultrasound-guided percutaneous neuromodulation

**Label:** PNM group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Other: dry needling

**Label:** Control group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- PNM group

**Description:** It´s an intervention of physiotherapy

**Name:** ultrasound-guided percutaneous neuromodulation

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** It´s an intervention of physiotherapy

**Name:** dry needling

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** Cumberland ankle instability tool

**Time Frame:** Change from Baseline up to three months

#### Secondary Outcomes

**Description:** 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).

**Measure:** Byodex Balance System (BBS)

**Time Frame:** Change from Baseline up to 5 minutes

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

**Measure:** Electromyography muscle (EMG)

**Time Frame:** Change from Baseline up to 5 minutes

**Description:** 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

**Measure:** stiffness tissue

**Time Frame:** Change from Baseline up to 5 minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Ankle instability

Exclusion Criteria:

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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Alcalá de Henares

**Country:** Spain

**Facility:** Physioterapy and Pain center research

**State:** Madrid

**Zip:** 28805

#### Overall Officials

**Official 1:**

**Affiliation:** Alcala University

**Name:** Daniel Pecos-Martin, PhD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007869

- Term: Leg Injuries

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M18909

- Name: Ankle Injuries

- Relevance: HIGH

- As Found: Ankle Sprain

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016512

- Term: Ankle Injuries

### Misc Info Module

- Version Holder: 2024-05-24
