Effects of Percutaneous Neuromouldation of the Saphenous Nerve in Patients With Patellofemoral Pain
NCT Number: NCT06505382
Acronym: PNMSNPFP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patellofemoral Pain
Interventions: DIAGNOSTIC_TEST: Ultrasound-guided percutaneous neuromodulation
Sponsor: University of Alcala
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2025-06-30
Locations: Campus Cientifico-Tecnologico UAH.Colegio de León c/ Libreros, 21, Alcalá De Henares, Madrid, 28801, Spain

Summary:
The knee is a common source of musculoskeletal pain, with patellofemoral pain (PFP) standing out due to its high prevalence. This pain, frequent in adolescents and athletes, significantly impacts the quality of life by hindering daily activities such as climbing stairs and sitting for extended periods. Percutaneous neuromodulation of the saphenous nerve (PNM) emerges as a promising therapeutic approach in physiotherapy to alleviate these symptoms.

A randomized controlled clinical trial is proposed in adults with PFP. Participants will be divided into two groups: one will receive PNM of the saphenous nerve, while the other will be a control group receiving puncture without electrical stimulation. Pain, extension strength, and knee range of motion will be evaluated before and after the intervention using the AKPS scale. Three sessions will be conducted with specific intervals, and a follow-up assessment will be performed three months later.

Primary Outcome Measures: Patellofemoral Pain, To quantify "pain intensity," the Visual Analog Scale (VAS) will be used, allowing the patient to subjectively express the intensity of their pain. It consists of a 10 cm line, where one end represents complete absence of pain and the other end represents the maximum possible intensity of pain. The patient is asked to mark on the line the point that reflects their pain level, and the measurement is recorded in millimeters. Within the "pain intensity" variable, a sub-variable will record the difference in pain intensity before and after the invasive physiotherapy intervention, expressed as a percentage of relief. This approach will allow observation of pain evolution across different sessions and evaluation of the immediate effects of Percutaneous Ultrasound-guided Neuromodulation., Before and after the puncture in all interventions. Up to 4 months
Secondary Outcome Measures: Knee functionality, The Kujala Knee Pain Score (AKPS) will be primarily measured, consisting of 13 items related to specific symptoms and aggravating activities associated with patellofemoral pain (e.g., stairs, squatting, prolonged sitting, pain). Participants select a response for each item. All items are scored on a weighted basis and summed to give a score out of 100, where 0 represents maximum disability and 100 represents no disability., Before the puncture in all interventions. Up to 4 months
Other Outcome Measures: Strength of the knee, The subject to be evaluated will be positioned at the edge of the examination table with 85º of hip flexion and 90º of knee flexion. A padded strap will be placed 5 cm proximal to the lateral malleolus, attached to the pressure dynamometer, which in turn will be connected to a rigid strap. This setup allows for the assessment of isometric quadriceps contraction strength. Participants will perform a warm-up consisting of five submaximal and maximal isometric knee extension contractions (50-100% effort). Subsequently, they will perform 3 maximal isometric contractions lasting 3 seconds each, with 1 minute of rest between contractions. Finally, the highest force contraction will be recorded for data analysis., Before and after the puncture in all interventions. Up to 4 months|The range of motion of the knee, The measurement will be conducted with the volunteer in prone position. The pelvis will be stabilized by the weight of the volunteer, and the femur will be stabilized by the evaluating physiotherapist. From this starting position, the physiotherapist will instruct the volunteer to actively perform knee extension in the sagittal plane and coronal axis.

For measuring the extension movement, the physiotherapist will place the universal goniometer with its axis at the lateral epicondyle of the femur, the fixed arm parallel to the longitudinal axis of the femur, and the movable arm parallel to the longitudinal axis of the fibula, towards the lateral malleolus. The movement will begin to be measured from 90 degrees of knee flexion, instructing the subject to extend the heel away from the buttock until maximum extension is reached., Before and after the puncture in all interventions. Up to 4 months