Ultrasound-guided Percutaneous Neuromodulation in Anterior Cruciate Reconstruction (NMPeLCA)

European University

Status: Completed

Conditions: ACL Injury

Treatments: Other: Ultrasound-Guided Percutaneous Neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05606250

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Physical therapy protocol

No Intervention group

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

Experimental group

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).

Treatment:

Other: Ultrasound-Guided Percutaneous Neuromodulation