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Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain

Primary Purpose

Lower Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
NMP
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Lower Back Pain
  • Having no other therapy

Exclusion Criteria:

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

Sites / Locations

  • Blanca de la Cruz Torres

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

NMP in level 1

NMP in level 2

NMP in level 3

Arm Description

Participants in this group received NMP of the sciatic nerve in the gluteus region

Participants in this group received NMP of the sciatic nerve in the middle of the thigh

Participants in this group received NMP of the sciatic nerve before popliteus region

Outcomes

Primary Outcome Measures

Level of pain
Measured by Visual Analogue Scale (0, no pain; 100, max pain)
Range of motion
Measured by goniometer. Hip flexion, external and internal rotation range of motion
Y Balance Test
Stability body
Owestry questionnaire
Lower back pain questionnaire

Secondary Outcome Measures

Full Information

First Posted
April 12, 2020
Last Updated
October 3, 2021
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT04347265
Brief Title
Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain
Official Title
Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 8, 2020 (Actual)
Primary Completion Date
May 9, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In our 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 this 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. Thirty 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NMP in level 1
Arm Type
Experimental
Arm Description
Participants in this group received NMP of the sciatic nerve in the gluteus region
Arm Title
NMP in level 2
Arm Type
Experimental
Arm Description
Participants in this group received NMP of the sciatic nerve in the middle of the thigh
Arm Title
NMP in level 3
Arm Type
Experimental
Arm Description
Participants in this group received NMP of the sciatic nerve before popliteus region
Intervention Type
Other
Intervention Name(s)
NMP
Intervention Description
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 Measure Information:
Title
Level of pain
Description
Measured by Visual Analogue Scale (0, no pain; 100, max pain)
Time Frame
From baseline measurement up to 1 week
Title
Range of motion
Description
Measured by goniometer. Hip flexion, external and internal rotation range of motion
Time Frame
From baseline measurement up to 1 week
Title
Y Balance Test
Description
Stability body
Time Frame
From baseline measurement up to 1 week
Title
Owestry questionnaire
Description
Lower back pain questionnaire
Time Frame
From baseline measurement up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Lower Back Pain Having no other therapy Exclusion Criteria: Other pathology (discal hernia, injured limbs, neurological pathology) Belenophobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blanca De la Cruz Torres, PhD
Organizational Affiliation
University of Seville
Official's Role
Study Director
Facility Information:
Facility Name
Blanca de la Cruz Torres
City
Seville
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain

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