Ultrasound-guided Percutaneous Neuromodulation in Anterior Cruciate Reconstruction

NCT05606250 | Completed DMC

• 1 other identifier: h8yucsdh
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL Injury

Keywords

percutaneous neuromodulation; femoral nerve; ultrasound; acl reconstruction

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (7)

• Changes in DN4 scale en 12 weeks

  Before treatment / intervention and week 12.

• Changes in LEFS scale in 12 weeks

  Before treatment / intervention and week 12.

• Changes in range of movement in 12 weeks.

  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,

• Changes in pressure pain threshold in 12 weeks

  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,

• Changes in heart rate variability in 12 weeks

  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,

Study Arms (2)

Physical therapy protocol

NO INTERVENTION

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

EXPERIMENTAL

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).

Other: Ultrasound-Guided Percutaneous Neuromodulation

Interventions

Ultrasound-Guided Percutaneous Neuromodulation OTHER

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

Ultrasound-Guided Percutaneous Neuromodulation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Julio José Caballero López

Madrid, 28046, Spain

Location

Related Publications (6)

• 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.

  PMID: 34063673 BACKGROUND

• 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.

  PMID: 32403999 BACKGROUND

• 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.

  PMID: 30160335 BACKGROUND

• 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.

  PMID: 33876885 BACKGROUND

• 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.

  PMID: 28086940 BACKGROUND

• Caballero-Lopez J, Navarro-Santana M, Almazan-Polo J, Garcia-Sanz F, Diaz-Arribas MJ, Minaya-Munoz F, Romero-Morales C. Short-term effects of percutaneous electrical nerve stimulation on pain and muscle function in patients undergoing anterior cruciate ligament surgery: a randomized clinical trial. Front Rehabil Sci. 2025 Apr 29;6:1501703. doi: 10.3389/fresc.2025.1501703. eCollection 2025.

  PMID: 40365171 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Carlos Romero Morales, PT

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group: The subjects will receive physiotherapy treatment and the experimental group will receive combined treatment of physiotherapy and ultrasound-guided percutaneous neuromodulation.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: November 4, 2022
• Study Start: January 20, 2022
• Primary Completion: April 20, 2022
• Study Completion: January 15, 2024
• Last Updated: March 21, 2024

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting in November 2023
• Access Criteria: The data obtained through this study can be provided to qualified researchers with an academic interest in percutaneous ultrasound-guided neuromodulation.

Locations

ES (1)