Clinical trial NCT05606250: Ultrasound-guided Percutaneous Neuromodulation in Anterior Cruciate Reconstruction
Official title: Effectiveness of the Ultrasound-guided Percutaneous Neuromodulation Technique in Post-surgical Anterior Cruciate Ligament Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL Injury
Keywords: percutaneous neuromodulation
femoral nerve
ultrasound
acl reconstruction
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in pain through the visual analogue scale in 12 weeks
timeFrame: 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 outcomes:
measure: Changes in DN4 scale en 12 weeks
timeFrame: Before treatment / intervention and week 12.
measure: Changes in LEFS scale in 12 weeks
timeFrame: Before treatment / intervention and week 12.
measure: Changes in range of movement in 12 weeks.
timeFrame: 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,
measure: Changes in pressure pain threshold in 12 weeks
timeFrame: 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,
measure: Changes in heart rate variability in 12 weeks
timeFrame: 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,
measure: Changes in dynamometry in 12 weeks.
timeFrame: 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,
measure: Body Mass Index
timeFrame: Before treatment / intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Julio José Caballero López
Study officials:
affiliation: Universidad Europea de Madrid
name: Carlos Romero Morales, PT
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.