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

July 14, 2024 updated by: Maria Castro Rodriguez, University of Alcala

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Madrid
      • Alcalá De Henares, Madrid, Spain, 28801
        • Campus Cientifico-Tecnologico UAH.Colegio de León c/ Libreros, 21
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PNM group

Participants in the experimental PNM group will receive ultrasound-guided percutaneous neuromodulation of the saphenous nerve in the painful leg.

In this study, a neurostimulation device ITO ES-160 will be used, where parameters of 2 Hz, 250 μs, and 16 minutes of continuous current will be set, with an appropriate intensity for subjects to perceive nerve stimulation along the path of the nerve (from the needle insertion point to the anterior aspect and below the knee), always ensuring it remains tolerable for them. No motor response will be observed. The black clip of channel 1 will be attached to the needle, and a TENS patch will be attached to the red clip.

The interventions will be conducted 3 times, with 1 week between the first two and a 2-week interval between the second intervention and the third. All measurements will be taken before and after the procedure.
Diagnostic test: Ultrasound-guided percutaneous neuromodulation
Percutaneous ultrasound-guided neuromodulation of the saphenous nerve in subjects with patellofemoral pain to assess its positive effects on pain and functionality.
Placebo Comparator: NON-PNM group

Participants in the control NON-PNM group will receive saphenous nerve puncture in the injured leg with subsequent placement of the clamps but without activating the electrostimulation function.

The needle will remain without current for 16 minutes. The interventions will be conducted 3 times, with 1 week between the first two and a 2-week interval between the second intervention and the third. All measurements will be taken before and after the procedure.
Diagnostic test: Ultrasound-guided percutaneous neuromodulation
Percutaneous ultrasound-guided neuromodulation of the saphenous nerve in subjects with patellofemoral pain to assess its positive effects on pain and functionality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before and after the puncture in all interventions. Up to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before the puncture in all interventions. Up to 4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before and after the puncture in all interventions. Up to 4 months
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.
Before and after the puncture in all interventions. Up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Investigators

  • Principal Investigator: Maria Castro-Rodriguez, B.S, University of Alcalá
  • Principal Investigator: Samuel Fernandez-Carnero, PhD, University of Alcalá

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

July 14, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

July 14, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Saphenous Nerve

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Patellofemoral Pain

Clinical Trials on Ultrasound-guided percutaneous neuromodulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe