Ultrasound-guided Percutaneous Neuromodulation in Anterior Cruciate Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-20

Study Completion Date

2024-01-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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ACL Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Physical therapy protocol

The physiotherapy protocol is based on manual therapy (passive joint mobilization), myofascial work, active exercise, high intensity neuromuscular electrical stimulation and cryotherapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Ultrasound-Guided Percutaneous Neuromodulation

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).

Group Type EXPERIMENTAL

Ultrasound-Guided Percutaneous Neuromodulation

Intervention Type 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

Interventions

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Ultrasound-Guided Percutaneous Neuromodulation

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No