Skip to content

Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain

Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain: a Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04347265
Enrollment
30
Registered
2020-04-15
Start date
2020-05-08
Completion date
2020-07-01
Last updated
2021-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Back Pain

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

Interventions

OTHERNMP

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.

Sponsors

University of Seville
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of Lower Back Pain * Having no other therapy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Level of painFrom baseline measurement up to 1 weekMeasured by Visual Analogue Scale (0, no pain; 100, max pain)
Range of motionFrom baseline measurement up to 1 weekMeasured by goniometer. Hip flexion, external and internal rotation range of motion
Y Balance TestFrom baseline measurement up to 1 weekStability body
Owestry questionnaireFrom baseline measurement up to 1 weekLower back pain questionnaire

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026