Ultrasound-Guided Percutaneous Neuromodulation in Spasticity

Status unknownNot a drug-phase studyMS (type not specified)NCT05053984

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Percutaneous Echoguided Neuromodulation

What it measured

Main measures

  • Spasticity

    8 weeks

    Spasticity
  • Patient's quality of life

    8 weeks

    Quality of life (reported by participants)
  • Patient Functionality

    8 weeks

  • 9 hole peg test

    8 weeks

    Disability progression
  • Muscle strength

    8 weeks

    Physical function
  • Range of Motion

    8 weeks

    Arm and hand function
  • Satisfaction Scale

    Immediately after the treatment

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 55

Show the full criteria

Inclusion criteria

* Sign the consent form to participate in the study * Be a patient diagnosed with Multiple Sclerosis. * Be over 18 years of age and less than or equal to 55 years of age. * Have spasticity (Asworth 2) in the upper limb. * Be able to travel to the place of the session

Exclusion criteria

* Failure to comply with the above * Withdrawal of informed consent * Having a disease associated with MS that is incompatible with the technique. Use of anticoagulation * Cognitive impairment * Belenophobia

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Nov 2021

      2. Main results due

        Jan 2022

      3. Finished

        Jun 2022

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