Frequency Parameter Used to Apply Ultrasound-guided Neuromodulation Percutaneous

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: NMP

• Registration Number: NCT05106920
• Lead Sponsor: University of Seville

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-23
• Study First Submitted QC: 2021-10-23
• Study Start: 2021-11-03
• Primary Completion: 2021-11-03
• Study First Posted: 2021-11-04
• Study Completion: 2023-11-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diagnosis of Lower Back Pain
• Having no other therapy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMP 3 Hz	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.
NMP 10 Hz	NMP	Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 10 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 Measures

Name	Time	Method
Range of motion	From baseline measurement up to 1 week	Measured by goniometer. Hip flexion, external and internal rotation range of motion
Level of pain	From baseline measurement up to 1 week	Measured by Visual Analogue Scale (0, no pain; 100, max pain)
Strength	From baseline measurement up to 1 week	Measured by dynamometer. Hip flexion, abduction, external and internal rotation muscle strength
Owestry questionnaire	From baseline measurement up to 1 week	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).
Y Balance Test	From baseline measurement up to 1 week	Stability body

Trial Locations

Locations (1)

University of Seville; 🇪🇸 Seville, Spain