Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain

NCT04347265 | Completed

• 1 other identifier: NMP in lower back pain
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Lower Back Pain

Outcome Measures

Primary Outcomes (4)

• Level of pain

  Measured by Visual Analogue Scale (0, no pain; 100, max pain)

  From baseline measurement up to 1 week

• Range of motion

  Measured by goniometer. Hip flexion, external and internal rotation range of motion

  From baseline measurement up to 1 week

• Y Balance Test

  Stability body

  From baseline measurement up to 1 week

• Owestry questionnaire

  Lower back pain questionnaire

  From baseline measurement up to 1 week

Study Arms (3)

NMP in level 1

EXPERIMENTAL

Participants in this group received NMP of the sciatic nerve in the gluteus region

Other: NMP

NMP in level 2

EXPERIMENTAL

Participants in this group received NMP of the sciatic nerve in the middle of the thigh

Other: NMP

NMP in level 3

EXPERIMENTAL

Participants in this group received NMP of the sciatic nerve before popliteus region

Other: NMP

Interventions

NMP OTHER

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 in level 1; NMP in level 2; NMP in level 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Lower Back Pain
• Having no other therapy

You may not qualify if:

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

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Blanca de la Cruz Torres

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Blanca De la Cruz Torres, PhD

  University of Seville

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 15, 2020
• Study Start: May 8, 2020
• Primary Completion: May 9, 2020
• Study Completion: July 1, 2020
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)