Ultrasound-guided Neuromodulation Percutaneous

Low Back Pain Clinical Trial

Official title:

Ultrasound-guided Percutaneous Neuromodulation on Hip Muscle Strength

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04590443
• Other study ID #: Place-NMP
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: July 10, 2021

Study information

• Verified date: November 2021
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 10, 2021
• Est. primary completion date: July 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Lower Back Pain

• Having no other therapy

Exclusion Criteria:

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

• Belenophobia

Related Conditions & MeSH terms

• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
Spain	Blanca de la Cruz Torres	Seville

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of pain	Measured by Visual Analogue Scale (0, no pain; 100, max pain)	From baseline measurement up to 1 week
Primary	Hip internal rotation range of motion	Measured by goniometer.	From baseline measurement up to 1 week
Primary	Muscle strength	Measured by dinamometer. Flexor, extensor, abductor, internal and external rotator muscles	From baseline measurement up to 1 week
Primary	Owestry questionnaire	Lower back pain questionnaire (0, min; 100, max)	From baseline measurement up to 1 week