- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05106920
Frequency Parameter Used to Apply Ultrasound-guided Neuromodulation Percutaneous (Parameters NMP)
How we Apply Ultrasound-guided Neuromodulation in Lower Back Pain Sufferers
In the daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain (LBP). Regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, including neuromodulation.
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 the study is to analyze that the effect of PNM on the sciatic nerve produces statistically significant changes in pain, joint range and functionality in patients with chronic LBP. Forty subjects will be recruited, which will be divided into 2 groups: group 1 to which PNM will be applied to the sciatic nerve at 250 microseconds, 3 Hz) during 90 seconds; group 2 to which PNM will be applied to the sciatic nerve in at 250 microseconds, 10 Hz during 90 second. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seville, Spain, 41009
- University of Seville
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of Lower Back Pain
- Having no other therapy
Exclusion Criteria:
- Other pathology (discal hernia, injured limbs, neurological pathology)
- Belenophobia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NMP 3 Hz
Participants received the percutaneous electrical stimulation intervention.
Specifically, this consisted of the application of a square wave biphasic electrical current, with 3 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction.
The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations.
A trained physiotherapist performed the PNM intervention.
|
Participants received the percutaneous electrical stimulation intervention.
Specifically, this consisted of the application of a square wave biphasic electrical current, to cause a tolerable muscle contraction.
The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations.
A trained physiotherapist performed the PNM intervention.
|
Experimental: NMP 10 Hz
Participants received the percutaneous electrical stimulation intervention.
Specifically, this consisted of the application of a square wave biphasic electrical current, with 10 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction.
The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations.
A trained physiotherapist performed the PNM intervention.
|
Participants received the percutaneous electrical stimulation intervention.
Specifically, this consisted of the application of a square wave biphasic electrical current, to cause a tolerable muscle contraction.
The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations.
A trained physiotherapist performed the PNM intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of pain
Time Frame: From baseline measurement up to 1 week
|
Measured by Visual Analogue Scale (0, no pain; 100, max pain)
|
From baseline measurement up to 1 week
|
Owestry questionnaire
Time Frame: From baseline measurement up to 1 week
|
Lower back pain questionnaire.
The final result is classified as minimal disability (0-20), moderate disability (21-40), severe disability (41-60), crippled (61-80) and bed-bound or exaggerating their symptoms (81-100).
|
From baseline measurement up to 1 week
|
Range of motion
Time Frame: From baseline measurement up to 1 week
|
Measured by goniometer.
Hip flexion, external and internal rotation range of motion
|
From baseline measurement up to 1 week
|
Y Balance Test
Time Frame: From baseline measurement up to 1 week
|
Stability body
|
From baseline measurement up to 1 week
|
Strength
Time Frame: From baseline measurement up to 1 week
|
Measured by dynamometer.
Hip flexion, abduction, external and internal rotation muscle strength
|
From baseline measurement up to 1 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMP-Frequency
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Ache Laboratorios Farmaceuticos S.A.Unknown
-
Palmer College of ChiropracticDepartment of Health and Human ServicesCompletedChronic Low Back Pain | Subacute Low Back PainUnited States
-
Universität Duisburg-EssenSiemens-BetriebskrankenkasseCompletedChronic Low Back Pain | Recurrent Low Back Pain
-
Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
Clinical Trials on NMP
-
University of SevilleCompleted
-
Induce Biologics USA Inc.Enrolling by invitation
-
Erasmus Medical CenterUniversity Medical Center Groningen; Leiden University Medical CenterRecruitingComplication of Surgical Procedure | Liver Transplant | Organ PerfusionNetherlands
-
Peter MacCallum Cancer Centre, AustraliaMelbourne HealthCompleted
-
Washington University School of MedicineOrganOx Ltd.; Mid-America TransplantRecruiting
-
Universidad Europea de CanariasNot yet recruiting
-
Induce Biologics USA Inc.Not yet recruitingDegenerative Disc Disease | Spinal Stenosis | Degenerative SpondylolisthesisUnited States
-
OrganOx Ltd.North American Science Associates Ltd.Terminated
-
Massachusetts General HospitalNot yet recruiting