Ultrasound-guided Neuromodulation Percutaneous

NCT04590443 | Completed

• 1 other identifier: Place-NMP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic low back pain (LBP) is one of the most familiar musculoskeletal pains and alone has been the main origin of years lived with disability for the past three decades. LBP is identified as a nonspecific, painful or mechanical situation in the lower back, buttocks, or hips. Although an underlying origin in chronic LBP has been proposed to be due to a multitude of factors, a muscle hip disbalance has been recognized5. A limited hip internal rotation range of motion (IR-ROM) and hip abductor weakness were found in patients with LBP symptoms7 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. However, authors hypothesize that neuromodulation (especially the US-guided PNM technique) may be used to obtain more therapeutic effects, including pain relief. The main aim of this study was to investigate the effect of hip muscle strengthening by a simple single-shot procedure with the US-guided PNM technique in people with LBP. A second purpose was to discover if the stimulation point in the sciatic nerve territory may influence the change of strength in these patients Sixty 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

Low 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

• Hip internal rotation range of motion

  Measured by goniometer.

  From baseline measurement up to 1 week

• Muscle strength

  Measured by dinamometer. Flexor, extensor, abductor, internal and external rotator muscles

  From baseline measurement up to 1 week

• Owestry questionnaire

  Lower back pain questionnaire (0, min; 100, max)

  From baseline measurement up to 1 week

Study Arms (3)

NMP in Infrapiriformis level

EXPERIMENTAL

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

Other: NMP

NMP in middle thigh level

EXPERIMENTAL

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

Other: NMP

NMP in middle distal level

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 Infrapiriformis level; NMP in middle distal level; NMP in middle thigh level

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 Design

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

Study Record Dates

• First Submitted: October 10, 2020
• First Posted: October 19, 2020
• Study Start: October 20, 2020
• Primary Completion: July 2, 2021
• Study Completion: July 10, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Locations

ES (1)