Effectiveness of the Ultrasound-guided Percutaneous Neuromodulation Technique in Post-surgical Anterior Cruciate Ligament Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- ACL Injury
- Sponsor
- Universidad Europea de Madrid
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Changes in pain through the visual analogue scale in 12 weeks
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Detailed 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Changes in pain through the visual analogue scale in 12 weeks
Time Frame: 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,
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.
Secondary Outcomes
- 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 dynamometry 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 LEFS scale in 12 weeks(Before treatment / intervention and week 12.)
- Changes in DN4 scale en 12 weeks(Before treatment / intervention and week 12.)
- 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,)
- Body Mass Index(Before treatment / intervention)