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Ultrasound-guided Neuromodulation Percutaneous

Primary Purpose

Low 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 Low 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 Infrapiriformis level

NMP in middle thigh level

NMP in middle distal level

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)
Hip internal rotation range of motion
Measured by goniometer.
Muscle strength
Measured by dinamometer. Flexor, extensor, abductor, internal and external rotator muscles
Owestry questionnaire
Lower back pain questionnaire (0, min; 100, max)

Secondary Outcome Measures

Full Information

First Posted
October 10, 2020
Last Updated
November 18, 2021
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT04590443
Brief Title
Ultrasound-guided Neuromodulation Percutaneous
Official Title
Ultrasound-guided Percutaneous Neuromodulation on Hip Muscle Strength
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
July 2, 2021 (Actual)
Study Completion Date
July 10, 2021 (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
Chronic low back pain (LBP) is one of the most familiar musculoskeletal pains and alone has been the main origin of years lived with disability for the past three decades. LBP is identified as a nonspecific, painful or mechanical situation in the lower back, buttocks, or hips. Although an underlying origin in chronic LBP has been proposed to be due to a multitude of factors, a muscle hip disbalance has been recognized5. A limited hip internal rotation range of motion (IR-ROM) and hip abductor weakness were found in patients with LBP symptoms7 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, authors hypothesize that neuromodulation (especially the US-guided PNM technique) may be used to obtain more therapeutic effects, including pain relief. The main aim of this study was to investigate the effect of hip muscle strengthening by a simple single-shot procedure with the US-guided PNM technique in people with LBP. A second purpose was to discover if the stimulation point in the sciatic nerve territory may influence the change of strength in these patients 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

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
NMP in Infrapiriformis level
Arm Type
Experimental
Arm Description
Participants in this group received NMP of the sciatic nerve in the gluteus region
Arm Title
NMP in middle thigh level
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 middle distal level
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
Hip internal rotation range of motion
Description
Measured by goniometer.
Time Frame
From baseline measurement up to 1 week
Title
Muscle strength
Description
Measured by dinamometer. Flexor, extensor, abductor, internal and external rotator muscles
Time Frame
From baseline measurement up to 1 week
Title
Owestry questionnaire
Description
Lower back pain questionnaire (0, min; 100, max)
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
Facility Information:
Facility Name
Blanca de la Cruz Torres
City
Seville
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

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Ultrasound-guided Neuromodulation Percutaneous

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