Ultrasound-guided Neuromodulation Percutaneous

Ultrasound-guided Percutaneous Neuromodulation on Hip Muscle Strength

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: NMP

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 41009
    • Blanca de La Cruz Torres

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of Lower Back Pain
• Having no other therapy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NMP in Infrapiriformis level; Participants in this group received NMP of the sciatic nerve in the gluteus region	Other: 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.
EXPERIMENTAL: NMP in middle thigh level; Participants in this group received NMP of the sciatic nerve in the middle of the thigh	Other: 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.
EXPERIMENTAL: NMP in middle distal level; Participants in this group received NMP of the sciatic nerve before popliteus region	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Seville

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2020
• Primary Completion (ACTUAL): July 2, 2021
• Study Completion (ACTUAL): July 10, 2021

Study Registration Dates

• First Submitted: October 10, 2020
• First Submitted That Met QC Criteria: October 10, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Place-NMP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No