Clinical trial NCT06505382: Effects of Percutaneous Neuromouldation of the Saphenous Nerve in Patients With Patellofemoral Pain
Official title: Effects of Ultrasound-Guided Percutaneous Neuromodulation of the Saphenous Nerve for Pain Management and Functionality in Patellofemoral Pain Syndrome Patients: A Single-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patellofemoral Pain
Keywords: ultrasound-guided percutaneous neuromodulation
saphenous nerve
pain
functionality
femoropatellar pain
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Introduction: The knee is a common source of musculoskeletal pain, with patellofemoral pain (PFP) being one of the most prevalent. The incidence of PFP varies with age and activity level, but its impact on quality of life by causing pain and reduced functionality is significant. A high prevalence has been observed in adolescents and athletes, with symptoms interfering in daily activities such as climbing stairs, squatting, or sitting for prolonged periods. Percutaneous neuromodulation of the saphenous nerve emerges as a promising therapeutic approach to improve these patients' symptoms within the scope of physiotherapy.

Objectives: To determine the efficacy of a physiotherapy protocol based on ultrasound-guided percutaneous neuromodulation of the saphenous nerve on functional performance and pain in patients with PFP.

Materials and Methods: A randomized controlled clinical trial is proposed in adults with PFP symptoms. Volunteers will be divided into two groups: an intervention group and a control group. The experimental group will receive ultrasound-guided percutaneous neuromodulation (PNM) of the saphenous nerve, while the control group will only receive nerve puncture without electrical stimulation. The AKPS scale will be used to evaluate pain before and after the intervention, as well as knee extension strength and range of motion. Three sessions will be conducted with a one-week interval between the first two and a two-week interval between the second and third sessions. Finally, a follow-up assessment of all items without intervention will be conducted at three months

Eligibility criteria: Inclusion Criteria:

* Be 18 years or older.
* Knee pain in the anterior aspect or around the patella for at least 1 month, exacerbated by activities such as squatting, stair climbing, or prolonged sitting.
* Patients experiencing difficulty participating in sports due to pain.

Exclusion Criteria:

* Previous surgical intervention on the painful knee.
* Previous diagnosed knee pathology.
* Recent trauma or acute injury to the knee that may have led to the development of pain.
* Antiplatelet or anticoagulant therapy.
* Bilateral symptoms.
* Pain attributed to hypersensitivity of any peripheral nerve of the lower limbs or a positive electromyographic test.
* Lumbar spine pathologies (herniated disc, protrusion, etc.).
* Use of medications such as opioids or those with knee pain as a side effect.
* Belonephobia or any condition where percutaneous needle insertion is contraindicated.
* Pregnancy.

Primary outcomes:
measure: Patellofemoral Pain
timeFrame: Before and after the puncture in all interventions. Up to 4 months
Secondary outcomes:
measure: Knee functionality
timeFrame: Before the puncture in all interventions. Up to 4 months
Other outcomes:
measure: Strength of the knee
timeFrame: Before and after the puncture in all interventions. Up to 4 months
measure: The range of motion of the knee
timeFrame: Before and after the puncture in all interventions. Up to 4 months
Locations:
city: Alcalá De Henares
country: Spain
facility: Campus Cientifico-Tecnologico UAH.Colegio de León c/ Libreros, 21
state: Madrid
Study officials:
affiliation: University of Alcala
name: Maria Castro-Rodriguez, B.S
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alcala
name: Samuel Fernandez-Carnero, PhD
role: PRINCIPAL_INVESTIGATOR
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