Clinical trial NCT05053984: Ultrasound-Guided Percutaneous Neuromodulation in Spasticity
Official title: Ultrasound-Guided Percutaneous Neuromodulation in Spasticity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hospital Universitario de Canarias
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Spasticity
timeFrame: 8 weeks
measure: Patient's quality of life
timeFrame: 8 weeks
measure: Patient Functionality
timeFrame: 8 weeks
measure: 9 hole peg test
timeFrame: 8 weeks
measure: Muscle strength
timeFrame: 8 weeks
measure: Range of Motion
timeFrame: 8 weeks
measure: Satisfaction Scale
timeFrame: Immediately after the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: La Laguna
country: Spain
facility: UICEC
state: S/C De Tenerife
Study officials:
References: