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

NCT06505382 | Not Yet Recruiting

• 1 other identifier: Saphenous Nerve
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellofemoral Pain

Keywords

ultrasound-guided percutaneous neuromodulation; saphenous nerve; pain; functionality; femoropatellar pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Knee functionality

  Before the puncture in all interventions. Up to 4 months

Other Outcomes (2)

• Strength of the knee

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

• The range of motion of the knee

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

Study Arms (2)

PNM group

EXPERIMENTAL

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

NON-PNM group

PLACEBO COMPARATOR

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

Interventions

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.

NON-PNM group; PNM group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

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

Alcalá de Henares, Madrid, 28801, Spain

Location

Related Publications (10)

• Neal BS, Lack SD, Lankhorst NE, Raye A, Morrissey D, van Middelkoop M. Risk factors for patellofemoral pain: a systematic review and meta-analysis. Br J Sports Med. 2019 Mar;53(5):270-281. doi: 10.1136/bjsports-2017-098890. Epub 2018 Sep 21.

  PMID: 30242107 BACKGROUND

• Dutton RA, Khadavi MJ, Fredericson M. Patellofemoral Pain. Phys Med Rehabil Clin N Am. 2016 Feb;27(1):31-52. doi: 10.1016/j.pmr.2015.08.002.

  PMID: 26616176 BACKGROUND

• Boling MC, Padua DA, Marshall SW, Guskiewicz K, Pyne S, Beutler A. A prospective investigation of biomechanical risk factors for patellofemoral pain syndrome: the Joint Undertaking to Monitor and Prevent ACL Injury (JUMP-ACL) cohort. Am J Sports Med. 2009 Nov;37(11):2108-16. doi: 10.1177/0363546509337934. Epub 2009 Sep 24.

  PMID: 19797162 BACKGROUND

• Thomee R, Renstrom P, Karlsson J, Grimby G. Patellofemoral pain syndrome in young women. II. Muscle function in patients and healthy controls. Scand J Med Sci Sports. 1995 Aug;5(4):245-51.

  PMID: 7552770 BACKGROUND

• Jensen R, Kvale A, Baerheim A. Is pain in patellofemoral pain syndrome neuropathic? Clin J Pain. 2008 Jun;24(5):384-94. doi: 10.1097/AJP.0b013e3181658170.

  PMID: 18496302 BACKGROUND

• De-la-Cruz-Torres B, Abuin-Porras V, Navarro-Flores E, Calvo-Lobo C, Romero-Morales C. Ultrasound-Guided Percutaneous Neuromodulation in Patients with Chronic Lateral Epicondylalgia: A Pilot Randomized Clinical Trial. Int J Environ Res Public Health. 2021 May 3;18(9):4877. doi: 10.3390/ijerph18094877.

  PMID: 34063673 BACKGROUND

• Arias-Buria JL, Cleland JA, El Bachiri YR, Plaza-Manzano G, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrical Nerve Stimulation of the Radial Nerve for a Patient With Lateral Elbow Pain: A Case Report With a 2-Year Follow-up. J Orthop Sports Phys Ther. 2019 May;49(5):347-354. doi: 10.2519/jospt.2019.8570. Epub 2019 Jan 18.

  PMID: 30658050 BACKGROUND

• San-Emeterio-Iglesias R, Minaya-Munoz F, Romero-Morales C, De-la-Cruz-Torres B. Correct Sciatic Nerve Management to Apply Ultrasound-Guided Percutaneous Neuromodulation in Patients With Chronic Low Back Pain: A Pilot Study. Neuromodulation. 2021 Aug;24(6):1067-1074. doi: 10.1111/ner.13396. Epub 2021 Apr 20.

  PMID: 33876885 BACKGROUND

• Beltra P, Ruiz-Del-Portal I, Ortega FJ, Valdesuso R, Delicado-Miralles M, Velasco E. Sensorimotor effects of plasticity-inducing percutaneous peripheral nerve stimulation protocols: a blinded, randomized clinical trial. Eur J Pain. 2022 May;26(5):1039-1055. doi: 10.1002/ejp.1928. Epub 2022 Mar 3.

  PMID: 35191131 BACKGROUND

• Rossi M, DeCarolis G, Liberatoscioli G, Iemma D, Nosella P, Nardi LF. A Novel Mini-invasive Approach to the Treatment of Neuropathic Pain: The PENS Study. Pain Physician. 2016 Jan;19(1):E121-8.

  PMID: 26752480 BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome; Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Castro-Rodriguez, B.S

  University of Alcala

  PRINCIPAL INVESTIGATOR

• Samuel Fernandez-Carnero, PhD

  University of Alcala

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Castro-Rodriguez, B.S

CONTACT

+34658101818; maria.castror@edu.uah.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: July 17, 2024
• Study Start: September 30, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)