NCT05053984

Ultrasound-Guided Percutaneous Neuromodulation in Spasticity

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hospital Universitario de Canarias · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease characterised by the appearance of lesions, characterised by heterogeneity in their anatomopathological, clinical and radiological presentation. Its aetiology is complex and multifactorial, with genetic and environmental interactions with a predominance in women (3:1) and is the second leading cause of disability in young adults (25-30 years). It has a socio-economic impact, affecting interpersonal relationships and causing a significant reduction in quality of life. MAIN OBJECTIVE To assess the effect on spasticity of the Percutaneous Ultrasound-guided Neuromodulation (PMN) technique in patients diagnosed with MS with upper limb spasticity. SECONDARY OBJECTIVES * To assess changes in the strength parameter of the wrist flexor musculature wrist before and after the application of a PMN programme. * To assess changes in the functionality scales (modified Asworth, established for spasticity * To assess changes in the range of motion (ROM) of the joints under study. * Assess changes in the quality of life scale (MSQOL54). * To assess the adverse effects of the technique. All patients will receive a Percutaneous Echoguided Neuromodulation (PNM) in the median nerve at the elbow, medial to the brachial artery, running between the humeral and ulnar heads of the pronator teres muscle. Once the nerve is located, a needle shall be inserted in the vicinity of the nerve and is stimulated using an electrical current with a frequency of 10 Hz, with a pulse width of 250 µs and a tolerable intensity causing a visible muscle cont raction for 1.5 minutes. After assessing the correct application of ethics in the study, it was decided to use the individual's own baseline data as a control group, as simulating the technique is complex.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
PROCEDURE	Percutaneous Echoguided Neuromodulation	Once the nerve is located, a needle is introduced in the vicinity of the nerve and is stimulated using an electrical current with a frequency of 10 Hz, with a pulse width of 250 µs and a tolerable intensity causing a visible muscle contraction for 1.5 minutes.

Timeline

• Start date: 2021-11-02
• Primary completion: 2022-01-31
• Completion: 2022-06-30
• First posted: 2021-09-23
• Last updated: 2021-09-23

Locations

1 site across 1 country: Spain