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Percutaneous Neuromodulation on the Anterior Pain Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03883737
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Blanca de la Cruz Torres, University of Seville

Study Description
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Brief Summary:
Anterior knee pain (AKP) is one of the most frequent pathologies of the lower limb, in young and adult subjects. In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. The objective of this study is to analyze that the effect of PNM on the femoral nerve produces statistically significant changes in pain, joint range and knee functionality in patients with chronic AKP. Thirty subjects will be recruited, which will be divided into 2 groups: group 1 to which PNM will be applied to the femoral nerve of the pain knee; and group 2 to which PNM will be applied to the femoral nerve of the non-pain knee. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current (250 microseconds, 10 Hz)

Condition or disease Intervention/treatment Phase
Neuromodulation Anterior Pain Knee Femoral Nerve Other: PNM Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of the Ultrasound-guided Percutaneous Neuromodulation on the Anterior Pain Knee: a Pilot Study
Actual Study Start Date : April 14, 2019
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : November 1, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1: PNM in pain knee
participants in whom PNM will be applied to the femoral nerve of the pain knee
 Other: PNM
an asymmetric rectangular biphasic current (250 microseconds, 10 Hz)
Experimental: Group 2: PNM in non-pain knee
participants in whom PNM will be applied to the femoral nerve of the non-pain knee
 Other: PNM
an asymmetric rectangular biphasic current (250 microseconds, 10 Hz)


Outcome Measures
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Primary Outcome Measures :
  1. visual analog scale (VAS) (0, no pain; 100, maximum pain). [ Time Frame: up to 1 week ]
    pain

  2. range joint [ Time Frame: up to 1 week ]
    goniometer

  3. VISA-p questionnaire (0, maximum pain; 100, no pain). [ Time Frame: up to 1 week ]
    Functional pain

  4. Kujala questionnaire (0, maximum pain; 100, no pain). [ Time Frame: up to 1 week ]
    Functional pain


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic anterior knee pain >3 months
  • older than 18 years-old

Exclusion Criteria:

  • Surgical intervention in the intervention area
  • Prosthesis or osteosynthesis in the intervention area
  • Cardiac or tumoral diseases
  • Coagulopathies
  • Be under the effects of certain medications
  • contraindication characteristic of the puncture
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883737


Locations
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Spain
University of Seville
Seville, Spain, 41010
Sponsors and Collaborators
University of Seville
More Information
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Additional Information:

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Responsible Party: Blanca de la Cruz Torres, Director, University of Seville
ClinicalTrials.gov Identifier: NCT03883737    
Other Study ID Numbers: PNM and knee
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No