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OpenTrials
Completed

NCT Number: NCT04347265

Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain

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

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Key information

Conditions

Lower Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blanca de la Cruz Torres

Seville, 41009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Lower Back Pain
  • Having no other therapy

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Level of pain

    Time frame: From baseline measurement up to 1 week

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

  2. Range of motion

    Time frame: From baseline measurement up to 1 week

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

  3. Y Balance Test

    Time frame: From baseline measurement up to 1 week

    Stability body

  4. Owestry questionnaire

    Time frame: From baseline measurement up to 1 week

    Lower back pain questionnaire

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2020
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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