Effects of Percutaneous Neuromouldation of the Saphenous Nerve in Patients With Patellofemoral Pain
NCT ID: NCT06505382
Last Updated: 2024-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
24 participants
INTERVENTIONAL
2024-09-30
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ultrasound-guided Percutaneous Neuromodulation in Anterior Cruciate Reconstruction
NCT05606250
Percutaneous Neuromodulation on the Anterior Pain Knee
NCT03883737
Ultrasound-guided Femoral Nerve Block Without Electrical Stimulation of Peripheral Nerves
NCT05209490
Evaluation of Optimal Dose of Local Anesthetics for Patient Controlled Continuous Femoral Nerve Block
NCT01198340
Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty.
NCT04681547
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Alcala
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Maria Castro Rodriguez
Physical Therapist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maria Castro-Rodriguez, B.S
Role: PRINCIPAL_INVESTIGATOR
University of Alcala
Samuel Fernandez-Carnero, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alcala
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Campus Cientifico-Tecnologico UAH.Colegio de León c/ Libreros, 21
Alcalá de Henares, Madrid, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Saphenous Nerve
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.