Echoguided Percutaneous Neuromodulation in the Management of Chronic Ankle Instability in Physically Active Subjects.

NCT05942417 | Completed DMC

• 1 other identifier: 2023137
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The lateral ankle complex sprain is the most prevalent musculoskeletal injury among the general population and athletes and is associated with long-term pain, disability, and high healthcare costs. One of the complications of a lateral ankle sprain is the development of chronic ankle instability (CAI). Conservative treatment is the initial therapeutic option for patients with CAI, however, the best strategies are not yet clear. Clinically, a new invasive technique has appeared, known as echoguided Percutaneous Neuromodulation (EPNM). To date there are no studies showing the efficacy of the technique in patients with CAI together with the combination of a neuromuscular exercise program. Participants: Volunteers and adults, from the group of students of the Gimbernat University School with a history of ankle sprain and physically active who meet the inclusion criteria. Study variables: Self-administered ankle function scales (Cumberland ankle instability tool: CAIT and foot and ankle ability:FAAM measure Scale), objective measurement of function in the lower limb (Test countermovement jump: CMJ and Side hop Test:SHT), measurement of isometric strength of the ankle musculature, measurement of dynamic balance (Test star excursion balance), range of motion measurement (Ankle Dorsiflexion) and pain measurement (Numeric pain rating scale: NPRS Scale). Procedures: After carrying out the assessment, the participants will be randomized to participate in a neuromuscular exercise intervention (control group) or in a neuromuscular exercise intervention together with an application of EPNM in the common peroneal nerve (control group). experimental). The duration of the intervention in both cases will be 3 weeks, where in the control group there will be 2 sessions per week of exercise and in the experimental group 2 sessions per week of exercise plus an application of EPNM. Objective and hypothesis: The main objective of the study will be to compare the short- and medium-term effects of both interventions in relation to the study variables to be measured. The investigators hypothesize that those patients who receive neuromodulation combined with the neuromuscular exercise program will have greater improvements.

Conditions

Transcutaneous Electric Nerve Stimulation; Ankle Injuries and Disorders : Chronic Ankle Instability; Exercise Therapy

Keywords

Ankle; exercise therapy; chronic ankle instability; echoguided percutaneous neuromodulation

Outcome Measures

Primary Outcomes (3)

• "Foot and ankle ability measure" : FAAM questionnaire

  It is a Likert scale that consists of 29 items, which have a score from 0 to 4, representing different levels of difficulty, divided into two subscales: activities of daily living (ADL) (21 items) and sports (8 items). items). The values are added to calculate the result of each subscale, 84 points for ADLs and 32 points for sports. For the analysis of the result, the percentage of each subscale is used separately. The test-retest reliability is high, 0.89 for the ADLs and 0.87 for the sports subscale. In fact, the FAAM scale has been shown to be valid for use in patients with ankle instability. It has been suggested that the minimal clinically important difference (MCID) is 8 and 9 points for the ADL subscale and the sports subscale, respectively.

  Through study completion, an average of 1 year

• "Cumberland Ankle Instability Tool" (CAIT)

  It has shown to be a valid and reliable tool to assess functional ankle instability. With an intraclass correlation coefficient (ICC) of 0.96, the CAIT scale has demonstrated excellent test-retest reliability. The scale consists of 9 items with a maximum score of 30 points, where the highest results indicate greater stability. It has been suggested that the MCID is 3 or more points.

  Though study completion, an average of 1 year

• "Numeric Pain Rating Scale" (NPRS)

  Scale used to assess pain intensity, where 0 is absence of pain and 10 represents maximum pain.There are no data for the MCID in patients with CAI, however it appears that changes between 1.5 and 2.1 points can be considered as the MCID for patients with musculoskeletal pain conditions. This variable will ask about the intensity of pain during sports practice.

  Through study completion, an average of 1 year

Secondary Outcomes (5)

• "Side hop test" (SHT)

  Though study completion, an average of 1 year

• "Countermovement jump unilateral test" (Unilateral CMJ)

  Though study completion, an average of 1 year

• Isometric ankle strength measurement

  Though study completion, an average of 1 year

• "Star Excursion Balance Test" (SEBT)

  Though study completion, an average of 1 year

• Range of Motion (ROM)

  Though study completion, an average of 1 year

Study Arms (2)

Neuromodulation Percutaneous echoguided plus exercise

EXPERIMENTAL

The experimental group will receive a EPNM in the common peroneal nerve of the affected ankle. . Three interventions will be carried out, in a dosage of 1 per week. Moreover, a 3-week of strength exercises will be carried out with two sessions per week. The strength program includes a protocol for the use of Theraband ® according to that described by Kaminsky et al. Moreover, the participants will have to do a balance exercises program.The EPNM will be applied prior to the exercise program session

Procedure: Echoguided percutaneous neuromodulation plus exercise

Strength program

ACTIVE COMPARATOR

The strength program includes a Theraband® use protocol as described by Kaminsky et al. The balance exercise program will consist of performing a series of closed kinetic chain exercises in a weight-bearing standing position that will progress from bilateral to unilateral depending on the acceptance of the load.

Procedure: Strength program

Interventions

Echoguided percutaneous neuromodulation plus exercise PROCEDURE

This group is taking the EPNM and the exercise program

Neuromodulation Percutaneous echoguided plus exercise

Strength program PROCEDURE

This group is taking the exercise program

Strength program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• History of at least one major ankle sprain. The initial sprain must have occurred at least 12 months prior to study participation, be associated with inflammatory symptoms (pain, edema) and have generated at least one day of interruption in physical activity.
• The most recent sprain must have occurred at least 3 months prior to study participation.
• History in the injured ankle of "dropping the ankle" (at least 2 episodes in the 6 months prior to study participation) and/or repeated sprains (two or more sprains in the same ankle) and/or feelings of instability in activities of daily living or sports (score less than 24 on the Cumberland Ankle Instability Tool (CAIT).
• Have a score of less than 75% in three or more categories in the Foot and ankle Outcome Score(FAOS) or a level of less than 80% in sports activities in the Foot and ankle ability measure (FAAM).
• Pain on the Numeric pain rating scale (NPRS) above 3 points out of 10 in their physical activity.

You may not qualify if:

• History of surgery in either of the two lower extremities that may interfere with the performance of the tests.
• History of a fracture in either of the two lower extremities requiring alignment.
• Acute injury to the musculoskeletal structures of other lower extremity joints in the previous 3 months, which impact joint integrity and function, resulting in at least one day of loss of physical activity.
• Chronic concomitant pathology at the level of the lower extremity (for example: osteoarthritis, vascular disease, neural pathology).
• Regular use of analgesic medication that may mask symptoms.
• Contraindications of percutaneous puncture and specific to the execution of neuromodulation.
• Being receiving physiotherapy or medical treatment during the intervention.
• Being pregnant at the start of the study.

Sponsors & Collaborators

• Escoles Universitaries Gimbernat: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Escuelas Universitarias Gimbernat

Torrelavega, Cantabria, 39300, Spain

Location

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MeSH Terms

Conditions

Ankle Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ricardo Ortega

  Universidad Rey Juan Carlos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistical analysis investigator will be masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 12, 2023
• Study Start: October 1, 2023
• Primary Completion: January 15, 2025
• Study Completion: April 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data

Locations

ES (1)