Back to resultsUltrasound-guided Percutaneous Neuromodulation in Anterior Cruciate Reconstruction (NMPeLCA)
Primary Purpose
ACL Injury
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ultrasound-Guided Percutaneous Neuromodulation
Sponsored by
About this trial
This is an interventional treatment trial for ACL Injury focused on measuring percutaneous neuromodulation, femoral nerve, ultrasound, acl reconstruction
Eligibility Criteria
Inclusion Criteria: Subjects aged between 18 and 55 years who have undergone surgery for an anterior cruciate ligament (ACL) in a period of time between 2 and 6 weeks of evolution with or without meniscal injury (meniscal regularization / meniscal suture / meniscectomy, etc.). have pain or loss of sensitivity in the operated knee and that they have signed the informed consent. Exclusion Criteria: Subjects with chronic joint disease; prosthesis or osteosynthesis in the intervention area, as well as heart disease, neoplasia and coagulopathy. Subjects consuming analgesics. Subjects with belonephobia or insurmountable fear of needles History of lumbar pathology (lumbar hernia/protrusion) due to possible involvement of the lumbar plexus. Subjects with a history of neurological or orthopedic disorders Subjects with bilateral symptoms. Subjects with epilepsy, pacemaker or pregnant.
Sites / Locations
- Julio José Caballero López
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Physical therapy protocol
Ultrasound-Guided Percutaneous Neuromodulation
Arm Description
The physiotherapy protocol is based on manual therapy (passive joint mobilization), myofascial work, active exercise, high intensity neuromuscular electrical stimulation and cryotherapy.
Ultrasound-guided percutaneous neuromodulation (e-NMP) is the electrical stimulation by means of a needle with ultrasound guidance of a peripheral nerve at some point in its course or of a muscle at a motor point, with a therapeutic purpose. The application of the stimulation is carried out with a puncture needle accompanied by a low or medium frequency electrical current. In e-MPN, a sensory and/or motor response is sought when the peripheral nerve is stimulated, and a motor response is achieved by stimulating the motor point (uncontrolled exaggerated response that normalizes after the application of the technique).
Outcomes
Primary Outcome Measures
Changes in pain through the visual analogue scale in 12 weeks
It allows pain intensity to be measured with maximum reproducibility between observers. It consists of a horizontal line of 10 centimeters, at whose ends are the extreme expressions of a symptom. Absence or less intensity is located on the left and greater intensity on the right. The patient is asked to mark the point on the line that indicates the intensity and it is measured with a millimeter ruler.
This variable will be measured with a numerical value from 1 to 10.
Secondary Outcome Measures
Changes in DN4 scale en 12 weeks
The DN4 questionnaire consists of a total of 10 items grouped into 4 sections. The first seven elements are related to the quality of pain (burning, painful cold, electric shocks) and its association with abnormal sensations (pins and needles, tingling, numbness, itching). The other 3 items are related to the neurological examination in the painful area (tactile hypoesthesia, pinprick hypoesthesia, tactile allodynia). A score of 1 is given to each positive element and a score of 0 to each negative element. The total score is calculated as the sum of the 10 items and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.
This variable will be measured with a numerical value from 1 to 10.
Changes in LEFS scale in 12 weeks
measure the patient's baseline function, ongoing progress, and functional outcomes. This scale consists of 20 items, and the final score must be between 0 and 80. Items are rated on a 5-point scale, from 0 (extreme difficulty/ inability to perform the activity) to 4 (no difficulty).
This variable will be measured with a numerical value from 1 to 80.
Changes in range of movement in 12 weeks.
With goniometry, the patient's flexion and extension will be measured. This variable will be reflected with a numerical value and angle degrees.
Changes in pressure pain threshold in 12 weeks
Pressure pain threshold (PPT) was assessed with an analog algometer. One point on the epicondyle and five points on both knees (vastus lateralis, vastus medialis, patellar tendon, quadriceps tendon, and hamstring) were evaluated.
PPT points: (1) 10 cm lateral to the midpoint of the superior border of the patella; (2) 3 cm medial to the midpoint of the superior border of the patella; (3) midway between the inferior border of the patella and the tibial tuberosity; (4) 3 cm proximal to the superior border of the patella; and (5) 3 cm medial to the tibial tuberosity, at the insertion of pes anserinus.
When the individual reported a change in the sensation of pressure, the value indicated on the algometer was recorded. The subject did not receive information about the values obtained.
This variable will be reflected with numerical values. The PPT is expressed in kg/m^2 and was measured with an analog algometer.
Changes in heart rate variability in 12 weeks
The intervals between successive heartbeats (RR intervals) 2 (HRV) domains to detect changes in HRV Time domain (non-spectral): average RR intervals (ms); RMSSD (ms): the square root of the mean value of the sum of the squared differences of all successive R-R intervals; LRMSSD (ms): logarithm of the square root of the mean value of the sum of the squared differences of all successive R-R intervals: SDNN (ms): the standard deviation of the interval between beats from which artifacts were removed (NN); and PNN50: the percentage of differences between adjacent normal R-R intervals of more than 50 ms.
Frequency domain / spectral measurements (spectral) (HF) and (LF) (ms). minimum, maximum and average heart rate. The subject will be seated for a period of two minutes and thirty seconds. The data will be collected with the BERRY KING HEARTBEAT 2 heart rate meter, and the data will be record.This variable will be reflected with numerical values.
Changes in dynamometry in 12 weeks.
Dynamometry will be used to assess strength. This variable will be measured with a digital hand dynamometer called the Activ force 2 Digital Dynamometer. The patient will be seated on the stretcher and will actively do three isometric extensions with a 90º angle of knee flexion. This test will be carried out and the maximum extension force data will also be collected between the three knee extensions.
This variable will be reflected with numerical values.
Body Mass Index
weight and height will be combined to report BMI in kg/m^2
Full Information
NCT ID
NCT05606250
First Posted
October 17, 2022
Last Updated
November 2, 2022
Sponsor
Universidad Europea de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT05606250
Brief Title
Ultrasound-guided Percutaneous Neuromodulation in Anterior Cruciate Reconstruction
Acronym
NMPeLCA
Official Title
Effectiveness of the Ultrasound-guided Percutaneous Neuromodulation Technique in Post-surgical Anterior Cruciate Ligament Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
September 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Europea de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of the study is to demonstrate the efficacy of the ultrasound-guided percutaneous neuromodulation technique in the femoral nerve in patients who underwent surgery for the anterior cruciate ligament.
Detailed Description
After being informed about the study and the potential risks, all subjects who accept the study and give their informed consent in writing, the subjects will participate in a randomized, longitudinal and prospective clinical trial divided into two groups (control group and experimental group) with the main objective of demonstrating that the ultrasound-guided percutaneous neuromodulation technique is effective for the treatment of pain in subjects undergoing surgery for the anterior cruciate ligament.
Subjects belonging to the control group will perform a physiotherapy protocol and those belonging to the experimental group will undergo two interventions of the ultrasound-guided percutaneous neuromodulation technique combined with the physiotherapy protocol. The same number of measurements will be performed on all subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury
Keywords
percutaneous neuromodulation, femoral nerve, ultrasound, acl reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control group: The subjects will receive physiotherapy treatment and the experimental group will receive combined treatment of physiotherapy and ultrasound-guided percutaneous neuromodulation.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physical therapy protocol
Arm Type
No Intervention
Arm Description
The physiotherapy protocol is based on manual therapy (passive joint mobilization), myofascial work, active exercise, high intensity neuromuscular electrical stimulation and cryotherapy.
Arm Title
Ultrasound-Guided Percutaneous Neuromodulation
Arm Type
Experimental
Arm Description
Ultrasound-guided percutaneous neuromodulation (e-NMP) is the electrical stimulation by means of a needle with ultrasound guidance of a peripheral nerve at some point in its course or of a muscle at a motor point, with a therapeutic purpose.
The application of the stimulation is carried out with a puncture needle accompanied by a low or medium frequency electrical current.
In e-MPN, a sensory and/or motor response is sought when the peripheral nerve is stimulated, and a motor response is achieved by stimulating the motor point (uncontrolled exaggerated response that normalizes after the application of the technique).
Intervention Type
Other
Intervention Name(s)
Ultrasound-Guided Percutaneous Neuromodulation
Intervention Description
Ultrasound guided percutaneous neuromodulation in femoral nerve. Patients were placed in supine lying with the anterior aspect of the hip uncovered. The intervention consisted of the application of a biphasic square wave electric current, with a frequency of 2 Hz, a phase duration of 250μs, and a maximum tolerable intensity to cause an exacerbated muscle contraction for 15minutes in total
Primary Outcome Measure Information:
Title
Changes in pain through the visual analogue scale in 12 weeks
Description
It allows pain intensity to be measured with maximum reproducibility between observers. It consists of a horizontal line of 10 centimeters, at whose ends are the extreme expressions of a symptom. Absence or less intensity is located on the left and greater intensity on the right. The patient is asked to mark the point on the line that indicates the intensity and it is measured with a millimeter ruler.
This variable will be measured with a numerical value from 1 to 10.
Time Frame
Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
Secondary Outcome Measure Information:
Title
Changes in DN4 scale en 12 weeks
Description
The DN4 questionnaire consists of a total of 10 items grouped into 4 sections. The first seven elements are related to the quality of pain (burning, painful cold, electric shocks) and its association with abnormal sensations (pins and needles, tingling, numbness, itching). The other 3 items are related to the neurological examination in the painful area (tactile hypoesthesia, pinprick hypoesthesia, tactile allodynia). A score of 1 is given to each positive element and a score of 0 to each negative element. The total score is calculated as the sum of the 10 items and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.
This variable will be measured with a numerical value from 1 to 10.
Time Frame
Before treatment / intervention and week 12.
Title
Changes in LEFS scale in 12 weeks
Description
measure the patient's baseline function, ongoing progress, and functional outcomes. This scale consists of 20 items, and the final score must be between 0 and 80. Items are rated on a 5-point scale, from 0 (extreme difficulty/ inability to perform the activity) to 4 (no difficulty).
This variable will be measured with a numerical value from 1 to 80.
Time Frame
Before treatment / intervention and week 12.
Title
Changes in range of movement in 12 weeks.
Description
With goniometry, the patient's flexion and extension will be measured. This variable will be reflected with a numerical value and angle degrees.
Time Frame
Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
Title
Changes in pressure pain threshold in 12 weeks
Description
Pressure pain threshold (PPT) was assessed with an analog algometer. One point on the epicondyle and five points on both knees (vastus lateralis, vastus medialis, patellar tendon, quadriceps tendon, and hamstring) were evaluated.
PPT points: (1) 10 cm lateral to the midpoint of the superior border of the patella; (2) 3 cm medial to the midpoint of the superior border of the patella; (3) midway between the inferior border of the patella and the tibial tuberosity; (4) 3 cm proximal to the superior border of the patella; and (5) 3 cm medial to the tibial tuberosity, at the insertion of pes anserinus.
When the individual reported a change in the sensation of pressure, the value indicated on the algometer was recorded. The subject did not receive information about the values obtained.
This variable will be reflected with numerical values. The PPT is expressed in kg/m^2 and was measured with an analog algometer.
Time Frame
Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
Title
Changes in heart rate variability in 12 weeks
Description
The intervals between successive heartbeats (RR intervals) 2 (HRV) domains to detect changes in HRV Time domain (non-spectral): average RR intervals (ms); RMSSD (ms): the square root of the mean value of the sum of the squared differences of all successive R-R intervals; LRMSSD (ms): logarithm of the square root of the mean value of the sum of the squared differences of all successive R-R intervals: SDNN (ms): the standard deviation of the interval between beats from which artifacts were removed (NN); and PNN50: the percentage of differences between adjacent normal R-R intervals of more than 50 ms.
Frequency domain / spectral measurements (spectral) (HF) and (LF) (ms). minimum, maximum and average heart rate. The subject will be seated for a period of two minutes and thirty seconds. The data will be collected with the BERRY KING HEARTBEAT 2 heart rate meter, and the data will be record.This variable will be reflected with numerical values.
Time Frame
Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
Title
Changes in dynamometry in 12 weeks.
Description
Dynamometry will be used to assess strength. This variable will be measured with a digital hand dynamometer called the Activ force 2 Digital Dynamometer. The patient will be seated on the stretcher and will actively do three isometric extensions with a 90º angle of knee flexion. This test will be carried out and the maximum extension force data will also be collected between the three knee extensions.
This variable will be reflected with numerical values.
Time Frame
Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
Title
Body Mass Index
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
Before treatment / intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects aged between 18 and 55 years who have undergone surgery for an anterior cruciate ligament (ACL) in a period of time between 2 and 6 weeks of evolution with or without meniscal injury (meniscal regularization / meniscal suture / meniscectomy, etc.).
have pain or loss of sensitivity in the operated knee and that they have signed the informed consent.
Exclusion Criteria:
Subjects with chronic joint disease; prosthesis or osteosynthesis in the intervention area, as well as heart disease, neoplasia and coagulopathy.
Subjects consuming analgesics.
Subjects with belonephobia or insurmountable fear of needles
History of lumbar pathology (lumbar hernia/protrusion) due to possible involvement of the lumbar plexus.
Subjects with a history of neurological or orthopedic disorders
Subjects with bilateral symptoms.
Subjects with epilepsy, pacemaker or pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Romero Morales, PT
Organizational Affiliation
Universidad Europea de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Julio José Caballero López
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPDs collected
all IPDs underlying the results of a post
IPD Sharing Time Frame
starting in November 2023
IPD Sharing Access Criteria
The data obtained through this study can be provided to qualified researchers with an academic interest in percutaneous ultrasound-guided neuromodulation.
IPD Sharing URL
https://pubmed.ncbi.nlm.nih.gov
Citations:
PubMed Identifier
34063673
Citation
De-la-Cruz-Torres B, Abuin-Porras V, Navarro-Flores E, Calvo-Lobo C, Romero-Morales C. Ultrasound-Guided Percutaneous Neuromodulation in Patients with Chronic Lateral Epicondylalgia: A Pilot Randomized Clinical Trial. Int J Environ Res Public Health. 2021 May 3;18(9):4877. doi: 10.3390/ijerph18094877.
Results Reference
background
PubMed Identifier
32403999
Citation
De-la-Cruz-Torres B, Carrasco-Iglesias C, Minaya-Munoz F, Romero-Morales C. Crossover effects of ultrasound-guided percutaneous neuromodulation on contralateral hamstring flexibility. Acupunct Med. 2021 Oct;39(5):512-521. doi: 10.1177/0964528420920283. Epub 2020 May 13.
Results Reference
background
PubMed Identifier
30160335
Citation
Ilfeld BM, Said ET, Finneran JJ 4th, Sztain JF, Abramson WB, Gabriel RA, Khatibi B, Swisher MW, Jaeger P, Covey DC, Robertson CM. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Femoral Nerve for Postoperative Analgesia Following Ambulatory Anterior Cruciate Ligament Reconstruction: A Proof of Concept Study. Neuromodulation. 2019 Jul;22(5):621-629. doi: 10.1111/ner.12851. Epub 2018 Aug 30.
Results Reference
background
PubMed Identifier
33876885
Citation
San-Emeterio-Iglesias R, Minaya-Munoz F, Romero-Morales C, De-la-Cruz-Torres B. Correct Sciatic Nerve Management to Apply Ultrasound-Guided Percutaneous Neuromodulation in Patients With Chronic Low Back Pain: A Pilot Study. Neuromodulation. 2021 Aug;24(6):1067-1074. doi: 10.1111/ner.13396. Epub 2021 Apr 20.
Results Reference
background
PubMed Identifier
28086940
Citation
Ilfeld BM, Gilmore CA, Grant SA, Bolognesi MP, Del Gaizo DJ, Wongsarnpigoon A, Boggs JW. Ultrasound-guided percutaneous peripheral nerve stimulation for analgesia following total knee arthroplasty: a prospective feasibility study. J Orthop Surg Res. 2017 Jan 13;12(1):4. doi: 10.1186/s13018-016-0506-7.
Results Reference
background
Learn more about this trial
Ultrasound-guided Percutaneous Neuromodulation in Anterior Cruciate Reconstruction
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