Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05942417
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-06-26
Brief Title:
Echoguided Percutaneous Neuromodulation in the Management of Chronic Ankle Instability in Physically Active Subjects
Sponsor:
Escoles Universitaries Gimbernat
Organization:
Escoles Universitaries Gimbernat
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 abilityFAAM measure Scale objective measurement of function in the lower limb Test countermovement jump CMJ and Side hop TestSHT 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
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 abilityFAAM measure Scale objective measurement of function in the lower limb Test countermovement jump CMJ and Side hop TestSHT 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
Detailed 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 volleyballOne 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 functionClinically 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 studiedThe 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 subjects 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 coThe 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 025mmx040mm 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 3194 software Heinrich Heine Düsseldorf UniversityThe calculations have been based using an a priori analysis with a mixed F-Anova test for repeated measures with a Cohens d of 025 a 5 level of significance α 005 80 statistical power two groups and 3 repeated measures64 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 distributionhomoscedasticity 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 cohens d calculation A effect size less than 02 will be considered trivial between 02-05 low between 05-08 moderate and greater than 08 high
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 subjects 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 coThe 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 025mmx040mm 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 3194 software Heinrich Heine Düsseldorf UniversityThe calculations have been based using an a priori analysis with a mixed F-Anova test for repeated measures with a Cohens d of 025 a 5 level of significance α 005 80 statistical power two groups and 3 repeated measures64 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 distributionhomoscedasticity 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 cohens d calculation A effect size less than 02 will be considered trivial between 02-05 low between 05-08 moderate and greater than 08 high
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None