Percutaneous Neuromodulation on the Anterior Pain Knee
Effect of the Ultrasound-guided Percutaneous Neuromodulation on the Anterior Pain Knee: a Pilot Study
1 other identifier
interventional
28
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2019
CompletedFirst Posted
Study publicly available on registry
March 21, 2019
CompletedStudy Start
First participant enrolled
April 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedJuly 14, 2020
July 1, 2020
1 day
March 16, 2019
July 12, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Group 1: PNM in pain knee
EXPERIMENTALparticipants in whom PNM will be applied to the femoral nerve of the pain knee
Group 2: PNM in non-pain knee
EXPERIMENTALparticipants in whom PNM will be applied to the femoral nerve of the non-pain knee
Interventions
an asymmetric rectangular biphasic current (250 microseconds, 10 Hz)
Eligibility Criteria
You may qualify if:
- chronic anterior knee pain \>3 months
- older than 18 years-old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Seville
Seville, 41010, Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
March 16, 2019
First Posted
March 21, 2019
Study Start
April 14, 2019
Primary Completion
April 15, 2019
Study Completion
November 1, 2019
Last Updated
July 14, 2020
Record last verified: 2020-07