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

Exercise Therapy Clinical Trial

Official title:

Effects of Echoguided Percutaneous Neuromodulation (EPNM) of the Common Peroneal Nerve and Neuromuscular Exercise in the Management of Chronic Ankle Instability (CAI): a Randomized Clinical Trial (RCT).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942417
• Other study ID #: 2023137
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Escoles Universitaries Gimbernat
• Contact: Alberto Nava Varas
• Phone: +34667758327
• Email: alberto.nava[@]eug.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 4 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.

Description:

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 health costs. A review of ankle injuries on 70 analyzed sports established that lateral ankle sprains accounted for 77% of all injuries, where the highest incidence rates were found in sports characterized by running, changes of direction or running. jump like basketball, soccer or volleyball.One of the complications of lateral ankle sprain is the development of chronic ankle instability (CAI) characterized by repeated episodes or perceptions of ankle instability, persistent symptoms such as pain, swelling, and decreased function with limitations in activities of daily living and sports participation that persist more than a year after the initial injury. Conservative treatment is the initial therapeutic option for patients with CAI, however, the best strategies are not yet clear. Numerous rehabilitation protocols to improve CAI-associated deficits have been examined. These range from simple progressive strength work or postural dynamic balance protocols to multi-component (strength, balance, mobility) rehabilitation approaches with effective results in improving strength. , balance and in function.Clinically, a new invasive technique has appeared, known as echoguided Percutaneous Neuromodulation (EPNM). This minimally invasive intervention consists of the application of percutaneous electrical stimulation (biphasic square wave electrical current) through an acupuncture needle, as an electrode located in the vicinity of the nerve or motor point of the muscle to be treated under the guidance ultrasound where the generation of structural and excitation changes in the nerve is hypothesized, which as a consequence produces a decrease in its sensitization. It is an accessible, safe and economical technique to treat musculoskeletal conditions by physiotherapists. To date, there is limited evidence regarding its use. EPNM has been applied to different pathologies with good therapeutic results, but its use together with the combination of a multicomponent neuromuscular exercise program has never been studied.The main objective of the study will be to compare the effects in the short and medium term of an intervention with EPNM in the common peroneal nerve together with an exercise program in relation to the variables pain, range of motion in the ankle, strength of the ankle musculature , dynamic balance and functionality both in performance and in self-reports in patients with CAI.

Participants:

Voluntary subjects and adults, from the group of students of the Gimbernat University School with a history of ankle sprain and physically active, defined as participation in moderate aerobic physical activity of at least 30 minutes 5 days a week, or vigorous aerobic intensity of at least 20 minutes 3 days a week, will be evaluated to see if they can participate and be included in the study.

Variables under study:

Principal:

Self-administered scales: FAAM and CAIT. NPRS scale.

Secondaries:

Side hop test. Countermovement jump test. Star excursion balance test. Range of motion. Ankle Strength.

Randomization:

After the initial evaluation, the patients will be randomly assigned to receive a neuromuscular exercise program (control group) or to receive a neuromuscular exercise program plus a EPNM of the common peroneal nerve (experimental group). The hidden estimate is performed using a computer generated random table of numbers created prior to data collection by an outside researcher. Individualized and sequentially numbered index cards will be prepared. These will be placed in sealed opaque envelopes and the second external investigator will open the envelope and proceed with the treatment according to the screen.

Each group will be treated by a clinical physiotherapist, who will be the main investigator of the study, with more than 15 years of experience in the management of lower limb musculoskeletal injuries and more than 10 years of experience in the management of invasive techniques and ultrasound evaluation.

The researcher in charge of processing the data will be blinded with respect to belonging to the groups and likewise the researchers who will carry out the assessments will be blinded with respect to the group display of the participant. Participants in this study will not be blinded to their assigned group. All participants will read and sign an informed consent prior to inclusion in the study and will be asked to lead a lifestyle identical to the one they led before the start of the study.

Procedures:

Neuromuscular exercise program:

he strength program includes a protocol for using Theraband ® according to that described by Kaminsky et al. Participants will sit on the floor with one end of the Theraband attached to a back protector and the other end attached around the metatarsal heads of the foot to be worked on. The knee will be in full extension and the Theraband will initially be stretched to 170% of its resting length, without taking resistance into account. Strength exercises with bands will include ankle movements (dorsiflexion, inversion and eversion). The progression of the program will include an increase in series (1-3 sets of 8-10 repetitions) and an increase in resistance each week of the intervention depending on the subject's symptoms. Plantar flexion will be performed through the standing heel raise exercise. To progress the exercise in the three weeks, body weight will be taken into account. Therefore, during the first week the exercise will be performed with 30-35% of body weight, the second week with 40-45% and the third week with 50-55%.

The balance exercise program will consist of performing a series of exercises in a closed kinetic chain in a standing weight-bearing position that will be progressed from bilateral to unilateral depending on the acceptance of the load. The exercises applied in the study will be the bilateral squat and the unilateral squat in single-leg support with the maximum possible range of motion. To take into account the progress throughout the three weeks, in the bilateral squat during the first week you will work with 25-30% of the body weight, during the second week with 35-40% of the body weight and during the last week with 45-50% of body weight. In the unilateral squat you will work with 40% of the weight used in the squat each week. 3 sets of 10 repetitions will be performed. In the second week, the unilateral squat sets will be performed on an unstable platform (mat). Finally, in the third week, again with respect to the unilateral squat, a disturbance will be performed through the placement of a resistance band on the ankle that will favor greater activation of the muscles. The focus of all these exercises will be motor control on the ankle that allows increasing the strength of the intrinsic muscles and adequately contributes to the stabilization of the joint.

Echoguided percutaneous neuromodulation (EPNM):

The experimental group, apart from the exercise program, will receive a session of EPNM in the common peroneal nerve of the affected lower extremity. The EPNM will be applied prior to the exercise program session. 3 interventions will be carried out, in a dosage of 1 per week. It will be done with the electrostimulator (ES-160 co.).The participant will be placed in a prone position with the foot outside the stretcher. The motor part of the common peroneal nerve that affects the innervation of the superficial peroneal nerve will be searched through an Ultrasound scanner with a high-frequency linear transducer (10 Hz). A dry puncture needle (0.25mmx0.40mm, Barcelona, Spain) will be inserted until it is close to the perineurium and a biphasic square wave electric current will be applied to the needle, with a frequency of 2 Hz, a width of pulse of 250 μsec and a maximum tolerable intensity, in order to cause visible muscle contraction, according to the protocol of other studies. Ten stimulations will be performed with a duration of 10 seconds, with a rest period of 10 seconds between each stimulation. The needle will remain stationary throughout the intervention and the skin will be previously cleaned with isopropyl alcohol and chlorhexidine.

Assessment and monitoring:

The variables under study will be evaluated at 3 different times: pre-intervention measurement, post-intervention (a week after the intervention), medium-term measurement (a month after the intervention).

Adverse effects:

All patients will be asked to report any type of adverse effect they may experience throughout the study and up to one month after completion. An adverse effect is defined as a medium-term sequelae with any symptom perceived as painful or unacceptable by the participant and requiring treatment. As the introduction of the needle in some patients may induce post-treatment discomfort, subjects will be notified to report any incident. The EPNM has adverse effects that are infrequent and not serious, such as post-puncture pain that usually lasts from a few hours to a few days of mild intensity, the possible appearance of a bruise that will be minimized thanks to the use of the ultrasound and with pressure techniques on the area, the irritation of the nerve that will be minimized by the use of the ultrasound again and finally the possibility of infection, for this reason a disinfectant will be used on the area before the technique and gloves of a only use.

The therapeutic exercise program has been subsequently used by other research groups and is very safe because it is an incremental program individually adapted in intensity to each subject. Potential adverse effects are also rare, where the most common may be increased ankle pain, which will be controlled with load adaptation, possible generation of late-onset muscle soreness, which usually has a peak duration of 48 hours and a possible fall with the work of instability and disturbance, which is minimized with the presence of the therapist controlling the session at all times.

Sample size calculation:

The sample size and power calculation were calculated using the G-Power 3.1.9.4 software (Heinrich Heine Düsseldorf University).The calculations have been based using an a priori analysis with a mixed F-Anova test for repeated measures, with a Cohen's d of 0.25, a 5% level of significance (α= 0.05), 80% statistical power, two groups and 3 repeated measures(64). The estimated sample size was at least 28 subjects, 14 for each group. A dropout rate of 10% was considered during follow-up, so 17 subjects were finally included per group.

Statistical analysis of data:

1. Descriptive data in mean, range and standard deviation.

2. Normal distribution/homoscedasticity of the data (See whether the data are parametric or non-parametric).

3. Mixed-model repeated measures analysis of variance ( ANOVA) will used to see the interaction between time-group in the differentes variables.

4. Calculate the effect size of the difference between pre and post on the different variables with the cohen's d calculation. A effect size less than 0.2 will be considered trivial, between 0.2-0.5 low, between 0.5-0.8 moderate and greater than 0.8 high.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. 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.

2. The most recent sprain must have occurred at least 3 months prior to study participation.

3. 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).

4. 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 90% in activities of daily living or a level of less than 80% in sports activities in the Foot and ankle ability measure (FAAM).

5. Pain on the Numeric pain rating scale (NPRS) above 3 points out of 10 in their physical activity.

Exclusion Criteria:

1. History of surgery in either of the two lower extremities that may interfere with the performance of the tests.

2. History of a fracture in either of the two lower extremities requiring alignment.

3. 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.

4. Chronic concomitant pathology at the level of the lower extremity (for example:

osteoarthritis, vascular disease, neural pathology).

5. Regular use of analgesic medication that may mask symptoms.

6. Contraindications of percutaneous puncture and specific to the execution of neuromodulation.

7. Being receiving physiotherapy or medical treatment during the intervention.

8. Being pregnant at the start of the study.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Echoguided percutaneous neuromodulation plus exercise
This group is taking the EPNM and the exercise program
• Strength program
This group is taking the exercise program

Locations

Country	Name	City	State
Spain	Escuelas Universitarias Gimbernat	Torrelavega	Cantabria

Sponsors (2)

Lead Sponsor	Collaborator
Escoles Universitaries Gimbernat	Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

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* Note: There are 58 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"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
Primary	"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
Primary	"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	"Side hop test" (SHT)	Subjects will be asked to jump laterally and medially between two tape marks that are 30 centimeters apart 10 times as fast as possible. One repetition is considered a lateral jump of 30 cm and return to the starting position. Two series will be carried out and the total time in seconds necessary to complete each of them will be recorded. Time will be recorded by a hand chronometer [ICC 0.84, Standard error measurement(SEM) 2.10 seconds and MDC 5.82 seconds]. The rest between series will be one minute and the lowest time will be used for the study. If a participant falls, puts the contralateral foot on the ground or does not correctly complete the distance of 30 cm between the lines, we consider it invalid and the participant should repeat the test.	Though study completion, an average of 1 year
Secondary	"Countermovement jump unilateral test" (Unilateral CMJ)	For this test, subjects will be asked to perform a vertical jump in a standing position with their hands placed on their pelvis. To do this, there will first be a descent phase where the subjects will flex the knee approximately 90 degrees to then take off as quickly as possible keeping the lower extremity extended during the flight phase. The extremity that we do not value will remain at all times without contact on the ground. There will be 3 repetitions with a 30-second rest between each one where we will stay with the highest value. For the measurement, the My Jump 2 application will be used. The validity of the application has been seen to be high (ICC= 0.997, 95% (Intraclass Coefficient (CI): 0.996-0.998, P < 0.001) with an almost perfect correlation coefficient (r= 0.995, P< 0.001) between the application and the gold standard, which is a force platform.	Though study completion, an average of 1 year
Secondary	Isometric ankle strength measurement	Measurement of three muscle groups: the inverters, the evertors/plantarflexors, the inverters/dorsiflexors. Isometric assessment of the ankle in inversion/dorsiflexion and in eversion/plantarflexion selectively assesses the tibialis anterior and peroneus longus and brevis muscles, respectively. The measurement will be made with the Microfet2 hand pressure dynamometer (Hogan Scientific, LLC, Salt Lake City, USA. (ICC 0.61, 95% CI=0.09-0.81 for dorsiflexors, ICC 0.74, 95% CI= 0.425-0.879 for inverters and ICC 0.84, 95% CI=0.431-0.905 for evertors in the standardized positions to ensure consistency throughout the study. For this variable, 3 measurements of 5 seconds duration will be carried out with 20 seconds of rest between measurements. The value to take into account will be the peak isometric force in kg and will be normalized with the body mass of the subjects.	Though study completion, an average of 1 year
Secondary	"Star Excursion Balance Test" (SEBT)	Is a measure of dynamic balance that has been shown to be valid with moderate to good reliability.The 3 SEBT directions to be measured are the anterior, the posterolateral and the posteromedial, as support to previous investigations (ICC intra 0.85-0.91 and ICC inter 0.99-1) with reported minimum detectable change values (MDC). ) of the normalized reach distance of 5.9% for the anterior direction, 7.8% for the posteromedial direction, and 7.6% for the posterolateral direction. 3 consecutive measurements will be made in each direction. The order of the addresses will be randomized.	Though study completion, an average of 1 year
Secondary	Range of Motion (ROM)	Ankle dorsiflexion range of motion will be measured with the My Rom app (version 3.0.4). Its validity has been demonstrated with respect to the Limit® mini digital inclinometer (r = 0.989, 95% CI = 0.986-0.993) and its reliability (ICC = 0.976, 95% CI = 0.966- 0.983, Dorsiflex app Coefficient of variation(CV) = 5.1 ± 2.3%; Digital inclinometer CV = 4.9 ± 2.5%) during the lunge test under load.	Though study completion, an average of 1 year