Effectiveness of a Session of Analgesic Electrostimulation (Invasive and Non-invasive) Applied to the Quadriceps Muscle in Patients After Knee Surgery.

Universidad de Murcia

Status: Invitation-only

Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation

Treatments: Procedure: Invasive analgesic electrostimulation; Procedure: Non-invasive analgesic electrostimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06910150

CE112417

Details and patient eligibility

About

The anterior cruciate ligament (ACL) injury is one of the most prevalent injuries in the musculoskeletal system. Consequently, its surgical reconstruction is among the most commonly performed procedures in current clinical practice.

The aim of this clinical trial is to investigate if the application of a single session of electrical currents to the quadriceps muscle can reduce pain in individuals who have undergone ACL surgery. Additionally, the trial will assess whether this intervention increases the pressure pain threshold, mobility, strength and functionality of the operated knee, as well as improving the participant's quality of life. Effusion and edema of the operated knee will also be measured.

Participants in this clinical trial will be randomly assigned to three study groups: one control group and two experimental groups.

All participants will undergo a conventional physiotherapy program for knee rehabilitation. This program includes manual therapy with a physiotherapist and exercises aimed at strengthening the CORE, hip and knee muscles.

Participants in the first experimental group will receive an additional session of superficial (non-invasive) electrical currents applied to the quadriceps muscle of the operated knee.

Participants in the second experimental group will receive an additional session of invasive electrical currents applied to the quadriceps muscle of the operated knee.

Each patient will be assessed four times: before the intervention, immediately after the intervention, and 1 and 7 days post-intervention. Functionality of the operated knee and quality of life will only be assessed before the intervention and 7 days post-intervention using self-reported scales.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects aged between 18 and 55 years, regardless of gender.
• Subjects who have undergone surgical ACL reconstruction within the past six weeks, with or without additional procedures on one or both menisci due to their high concomitance, and with or without Lemaire reinforcement in the form of extra-articular lateral tenodesis.
• Subjects experiencing pain in the operated knee.
• Voluntary signing of the informed consent form for the study.

Exclusion criteria

• Contraindications for invasive therapies:
• Subjects with chronic joint pathology.
• Subjects with prostheses or osteosynthesis in the affected lower limb.
• Subjects with heart disease.
• Subjects with neoplasms.
• Subjects with coagulopathies.
• Subjects with epilepsy.
• Subjects with pacemakers.
• Pregnant patients.
• Subjects with belonephobia (severe fear of needles).
• Subjects with neuropathic pain.
• Subjects with central nervous system disorders.
• Subjects with a history of neurological disorders.
• Subjects with a history of lumbar hernia or protrusion due to a possible involvement of the lumbar plexus.
• Subjects with a history of spinal surgery.
• Subjects presenting any bilateral symptoms.
• Subjects with a BMI greater than 30 kg/m².
• Subjects taking analgesic medication.
• Subjects receiving any alternative treatment not proposed in this study, which could alter the results.
• Subjects scoring above 37.5 points on the "Personal Psychological Apprehension Scale in Physiotherapy".
• Contraindications for dynamometric measurement:
• Subjects with acute quadriceps muscle injury.
• Subjects with joint instability.
• Subjects with acute joint inflammation.
• Subjects who voluntarily withdraw from the study.
• Subjects absent for any measurement session.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Control group

No Intervention group

Description:

Participants will only undergo a conventional physiotherapy rehabilitation program for anterior cruciate ligament rehabilitation.

Experimental Group 1

Experimental group

Description:

Participants will undergo a conventional anterior cruciate ligament rehabilitation physiotherapy program and receive a single session of analgesic transcutaneous electrical nerve stimulation (TENS).

Treatment:

Procedure: Non-invasive analgesic electrostimulation

Experimental Group 2

Experimental group

Description:

Participants will undergo a conventional anterior cruciate ligament rehabilitation physiotherapy program and receive a single session of invasive analgesic electrostimulation (LTP, long-term potentiation).

Treatment:

Procedure: Invasive analgesic electrostimulation