Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain

Lower Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347265
• Other study ID #: NMP in lower back pain
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain

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