Ultrasound-guided Neuromodulation Percutaneous

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: NMP

• Registration Number: NCT04590443
• Lead Sponsor: University of Seville

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-10
• Study First Submitted QC: 2020-10-10
• Study First Posted: 2020-10-19
• Study Start: 2020-10-20
• Primary Completion: 2021-07-02
• Study Completion: 2021-07-10
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diagnosis of Lower Back Pain
• Having no other therapy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMP in middle distal level	NMP	Participants in this group received NMP of the sciatic nerve before popliteus region
NMP in Infrapiriformis level	NMP	Participants in this group received NMP of the sciatic nerve in the gluteus region
NMP in middle thigh level	NMP	Participants in this group received NMP of the sciatic nerve in the middle of the thigh

Primary Outcome Measures

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

Trial Locations

Locations (1)

Blanca de la Cruz Torres; 🇪🇸 Seville, Spain