NeuromodulationNCT03883737
Percutaneous Neuromodulation on the Anterior Pain Knee
A study testing PNM in people with Neuromodulation and Anterior Pain Knee, run by University of Seville at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Neuromodulation, Anterior Pain Knee, Femoral Nerve
- What is being tested?
- PNM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 14 Apr 2019to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic anterior knee pain >3 months
- older than 18 years-old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
- Conditions
- Neuromodulation, Anterior Pain Knee, Femoral Nerve
- Being tested
- PNM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNMOther
an asymmetric rectangular biphasic current (250 microseconds, 10 Hz)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: PNM in pain knee | Experimental | participants in whom PNM will be applied to the femoral nerve of the pain knee Receives: Other: PNM |
| Group 2: PNM in non-pain knee | Experimental | participants in whom PNM will be applied to the femoral nerve of the non-pain knee Receives: Other: PNM |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (VAS) (0, no pain; 100, maximum pain).
pain
Measured: up to 1 week
range joint
goniometer
Measured: up to 1 week
VISA-p questionnaire (0, maximum pain; 100, no pain).
Functional pain
Measured: up to 1 week
Kujala questionnaire (0, maximum pain; 100, no pain).
Functional pain
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start14 Apr 2019
- Primary completion15 Apr 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuromodulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca de la Cruz Torres, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883737
- Sponsor's protocol ID
- PNM and knee
- Status last verified
- Jul 2020
- First submitted
- 16 Mar 2019
- Last updated
- 14 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Ultrasound-guided Percutaneous Neuromodulation on the Anterior Pain Knee: a Pilot Study
- ClinicalTrials.gov ID
- NCT03883737
- Acronym / sponsor ID
- PNM and knee
- Conditions
- Neuromodulation, Anterior Pain Knee, Femoral Nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 14 Apr 2019 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: PNM in pain knee | Experimental | Other: PNMparticipants in whom PNM will be applied to the femoral nerve of the pain knee |
| Group 2: PNM in non-pain knee | Experimental | Other: PNMparticipants in whom PNM will be applied to the femoral nerve of the non-pain knee |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- chronic anterior knee pain >3 months
- older than 18 years-old
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNMan asymmetric rectangular biphasic current (250 microseconds, 10 Hz) | Other | Group 1: PNM in pain knee, Group 2: PNM in non-pain knee |
Primary outcome
visual analog scale (VAS) (0, no pain; 100, maximum pain).
Time frame: up to 1 week
pain
range joint
Time frame: up to 1 week
goniometer
VISA-p questionnaire (0, maximum pain; 100, no pain).
Time frame: up to 1 week
Functional pain
Kujala questionnaire (0, maximum pain; 100, no pain).
Time frame: up to 1 week
Functional pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNM in people with Neuromodulation and Anterior Pain Knee, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (VAS) (0, no pain; 100, maximum pain). (time frame: up to 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.