Clinical trial NCT06910150: Study of the Effectiveness of an Analgesic Electrostimulation Session (Invasive and Non-invasive) Applied on the Femoral Quadriceps Muscle in Patients Who Have Undergone an Anterior Cruciate Ligament Surgey: A Random Clinical Trial
Official title: Immediate Effectiveness of an Analgesic Electrostimulation Session on Femoral Quadriceps in Patients After Anterior Cruciate Ligament Reconstruction: A Random Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The anterior cruciate ligament (ACL) injury is one of the most prevalent injuries in the musculoskeletal system. Thus, its surgical reconstruction is one of the most commonly performed procedures currently.

The goal of this clinical trial is to investigate if the application of a single session of currents applied on the quadriceps muscle reduces pain in individuals who have undergone ACL surgery. Additionally, this clinical trial also investigates if that single session of currents raises the pressure pain threshold, mobility, strength, and functionality of the operated knee, plus the participant's quality of life. The effusion and edema of the operated knee is also measured.

The participants in the clinical trial will be randomly assigned to three study groups. The three study groups are a control group and two experimental groups.

All participants in the clinical trial will carry out a conventional physiotherapy program for knee rehabilitation. This program consists of manual therapy with a physiotherapist and exercises to strengthen the knee muscles.

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

Participants in the second experimental group will additionally receive a session of invasive currents applied to the quadriceps muscle of the operated knee.

Each patient will be measured 4 times: before and immediately after the intervention, 1 and 7 days following the intervention. Functionality of the operated knee and quality of life of the participants will only be measured before the intervention and 7 days after the intervention using self-reported scales.


Eligibility criteria: Inclusion Criteria:

* Subjects aged between 18 and 55 years old, regardless of gender.
* Subjects who have undergone surgical ACL reconstruction within the past six weeks, with or without additional surgical 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 study's informed consent.

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 neoplasia.
* 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 disease.
* Subjects with a history of neurological disorders.
* Subjects with a history of lumbar hernia or protrusion due to a plausible afectation 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 (EAPP) 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 who are absent for any measurement session.

Primary outcomes:
measure: Change in knee pain from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
timeFrame: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
measure: Change in knee range of movement from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
timeFrame: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
measure: Change in knee pain threshold to pressure from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
timeFrame: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
measure: Change in maximum isometric quadriceps strength from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
timeFrame: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
measure: Change in thigh muscle atrophy from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
timeFrame: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
measure: Change in knee intra-articular effusion from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
timeFrame: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
measure: Change in knee extra-articular edema from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
timeFrame: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
measure: Change in quality of life from baseline to seven days post-intervention.
timeFrame: From baseline to seven days post-intervention.
measure: Change in knee functionality from baseline to seven days post-intervention.
timeFrame: From baseline to seven days post-intervention.
measure: Needle apprehension at baseline
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clínica CEMTRO
Study officials:
affiliation: Universidad Católica San Antonio de Murcia (UCAM)
name: Luis Blanco-López, Physiotherapy
role: PRINCIPAL_INVESTIGATOR
References: