Frequency Parameter Used to Apply Ultrasound-guided Neuromodulation Percutaneous

Low Back Pain Clinical Trial

— Parameters NMP  

Official title:

How we Apply Ultrasound-guided Neuromodulation in Lower Back Pain Sufferers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05106920
• Other study ID #: NMP-Frequency
• Status: Completed
• Phase: N/A
• Start date: November 3, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: December 2023
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the 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 the 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. Forty subjects will be recruited, which will be divided into 2 groups: group 1 to which PNM will be applied to the sciatic nerve at 250 microseconds, 3 Hz) during 90 seconds; group 2 to which PNM will be applied to the sciatic nerve in at 250 microseconds, 10 Hz during 90 second. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 1, 2023
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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

Intervention

Other:
• NMP
Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, to cause a 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	University of Seville	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	Owestry questionnaire	Lower back pain questionnaire. The final result is classified as minimal disability (0-20), moderate disability (21-40), severe disability (41-60), crippled (61-80) and bed-bound or exaggerating their symptoms (81-100).	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	Strength	Measured by dynamometer. Hip flexion, abduction, external and internal rotation muscle strength	From baseline measurement up to 1 week