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NCT Number: NCT06505382

Effects of Percutaneous Neuromouldation of the Saphenous Nerve in Patients With Patellofemoral Pain

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.

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Key information

Conditions

Patellofemoral Pain Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Patellofemoral Pain Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus Cientifico-Tecnologico UAH.Colegio de León c/ Libreros, 21

Alcalá de Henares, Madrid, 28801, Spain

Location contact

Maria Castro-Rodriguez, B.S

CONTACT

[email protected]

+34658101818

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound-guided percutaneous neuromodulation

Diagnostic Test

Percutaneous ultrasound-guided neuromodulation of the saphenous nerve in subjects with patellofemoral pain to assess its positive effects on pain and functionality.

Primary outcomes

  1. Patellofemoral Pain

    Time frame: Before and after the puncture in all interventions. Up to 4 months

    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.

Secondary outcomes

  1. Knee functionality

    Time frame: Before the puncture in all interventions. Up to 4 months

    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.

Other outcomes

  1. Strength of the knee

    Time frame: Before and after the puncture in all interventions. Up to 4 months

    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.

  2. The range of motion of the knee

    Time frame: Before and after the puncture in all interventions. Up to 4 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Castro-Rodriguez, B.S

CONTACT

[email protected]

+34658101818

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study 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

Acronym: PNMSNPFP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2024
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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