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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04347265
Other study ID # NMP in lower back pain
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 8, 2020
Est. completion date July 1, 2020

Study information

Verified date October 2021
Source University of Seville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 1, 2020
Est. primary completion date May 9, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Diagnosis of Lower Back Pain - Having no other therapy Exclusion Criteria: - Other pathology (discal hernia, injured limbs, neurological pathology) - Belenophobia

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Spain Blanca de la Cruz Torres Seville

Sponsors (1)

Lead Sponsor Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of pain Measured by Visual Analogue Scale (0, no pain; 100, max pain) From baseline measurement up to 1 week
Primary Range of motion Measured by goniometer. Hip flexion, external and internal rotation range of motion From baseline measurement up to 1 week
Primary Y Balance Test Stability body From baseline measurement up to 1 week
Primary Owestry questionnaire Lower back pain questionnaire From baseline measurement up to 1 week
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