Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasound-guided Neuromodulation Percutaneous

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04590443
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Blanca de la Cruz Torres, University of Seville

Brief Summary:

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. However, The application methodology of this technique is not well developed.

The objective was to determine the most appropriate place of intervention of this technique in patients with chronic LBP.

Sixty subjects will be recruited, which will be divided into 3 groups: group 1 to which PNM will be applied to the sciatic nerve in the gluteus region; group 2 to which PNM will be applied to the sciatic nerve in the middle of the thigh; and group 3 to which PNM will be applied to the sciatic nerve before popliteus region. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current (250 microseconds, 3 Hz) during 90 seconds


Condition or disease Intervention/treatment Phase
Low Back Pain Other: NMP Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Neuromodulation Percutaneous: Is the Intervention Place Important?
Estimated Study Start Date : October 15, 2020
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: NMP in Infrapiriformis level
Participants in this group received NMP of the sciatic nerve in the gluteus region
Other: NMP
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.

Experimental: NMP in middle thigh level
Participants in this group received NMP of the sciatic nerve in the middle of the thigh
Other: NMP
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.

Experimental: NMP in middle distal level
Participants in this group received NMP of the sciatic nerve before popliteus region
Other: NMP
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.




Primary Outcome Measures :
  1. Level of pain [ Time Frame: From baseline measurement up to 1 week ]
    Measured by Visual Analogue Scale (0, no pain; 100, max pain)

  2. Range of motion [ Time Frame: From baseline measurement up to 1 week ]
    Measured by goniometer. Hip flexion, external and internal rotation range of motion

  3. Muscle strength [ Time Frame: From baseline measurement up to 1 week ]
    Measured by dinamometer. Flexor, extensor, abductor, internal and external rotator muscles

  4. Y Balance Test [ Time Frame: From baseline measurement up to 1 week ]
    Stability body

  5. Owestry questionnaire [ Time Frame: From baseline measurement up to 1 week ]
    Lower back pain questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Lower Back Pain
  • Having no other therapy

Exclusion Criteria:

  • Other pathology (discal hernia, injured limbs, neurological pathology)
  • Belenophobia

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): NCT04590443


Contacts
Layout table for location contacts
Contact: Blanca De-la-Cruz-Torres, PhD 954486528 bcruz@us.es

Locations
Layout table for location information
Spain
Blanca de la Cruz Torres Recruiting
Seville, Spain, 41009
Contact: Blanca De la Cruz Torres         
Sponsors and Collaborators
University of Seville
Layout table for additonal information
Responsible Party: Blanca de la Cruz Torres, Director, University of Seville
ClinicalTrials.gov Identifier: NCT04590443    
Other Study ID Numbers: Place-NMP
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Low Back Pain
Back Pain
Pain
Neurologic Manifestations