Percutaneous Neuromodulation on the Anterior Pain Knee

Effect of the Ultrasound-guided Percutaneous Neuromodulation on the Anterior Pain Knee: a Pilot Study

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)

Study Overview

• Status: Completed
• Conditions: Neuromodulation; Femoral Nerve; Anterior Pain Knee
• Intervention / Treatment: Other: PNM

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 41010
    • University of Seville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale (VAS) (0, no pain; 100, maximum pain).	pain	up to 1 week
range joint	goniometer	up to 1 week
VISA-p questionnaire (0, maximum pain; 100, no pain).	Functional pain	up to 1 week
Kujala questionnaire (0, maximum pain; 100, no pain).	Functional pain	up to 1 week

Collaborators and Investigators

• Sponsor: University of Seville

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 14, 2019
• Primary Completion (ACTUAL): April 15, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: March 16, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (ACTUAL): March 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 12, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PNM and knee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No