Ultrasound-Guided Percutaneous Neuromodulation in Spasticity

NCT ID: NCT05053984

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2022-06-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neuromodulation

This study has only 1 arm and the control group is their baseline data

Group Type: EXPERIMENTAL

Percutaneous Echoguided Neuromodulation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario de Canarias

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UICEC

San Cristóbal de La Laguna, S/C de Tenerife, Spain

Countries

Spain

Central Contacts

Alberto Javier Ormazábal

Role: CONTACT

922678968

Montserrat González Plata, MD

Role: CONTACT

montserrat.gonzalezplatas@gmail.com

922678968

Other Identifiers

NEUROECO

Identifier Type: -

Identifier Source: org_study_id