Spastic paraparesis is one of the most disabling functional deficits in the population with multiple sclerosis between 18 and 80 years of age and at any functional level. Infiltration with Botulinum Toxin is a clinical practice that has been carried out for years with clinical evidence of improvement in the patient's walking patterns and quality of life. We assume that the infiltration of this product can generate a direct benefit in the walking ability of these patients and secondarily improve their quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Echo-guided infiltration of botulinum toxin type A (Dysport®) in the lower limbs according to normal service practice
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Effectiveness of repeated Botulinum Toxin infiltrations using objective results obtained by the clinician (Six Minutes Walking Test - 6MWT).
To assess the effectiveness of repeated Botulinum Toxin infiltrations on gait in patients with Multiple Sclerosis who presented limb spasticity less than 4 weeks after infiltration and its maintenance over time at 12 months, using objective results obtained by the clinician (Six Minutes Walking Test - 6MWT). Higher scores mean a better outcome.
Time frame: 12 months
Effectiveness of repeated Botulinum Toxin infiltrations using results reported by the patient (Twelve item Multiple Sclerosis Walking Scale - MSWS-12).
To assess the effectiveness of repeated Botulinum Toxin infiltrations on gait in patients with Multiple Sclerosis who presented limb spasticity less than 4 weeks after infiltration and its maintenance over time at 12 months, using results reported by the patient (Twelve item Multiple Sclerosis Walking Scale - MSWS-12). Higher scores mean a worse outcome.
Time frame: 12 months
Evaluation of spasticity using Modified Ashworth Spasticity scale (MAS scale).
Evaluation of spasticity using Modified Ashworth Spasticity scale (MAS scale). Higher scores mean a worse outcome.
Time frame: 12 months
Evaluation of disability using Expanded Disability Status Scale de Kurtzke (EDSS scale).
Evaluation of disability using Expanded Disability Status Scale de Kurtzke (EDSS scale). Higher scores mean a worse outcome.
Time frame: 12 months
Evaluation of the quality of life after the use of botulinum toxin type A using Multiple Sclerosis Quality of Life 54 (MSQoL-54).
Evaluation of the quality of life after the use of botulinum toxin type A using Multiple Sclerosis Quality of Life 54 (MSQoL-54). Higher scores mean a better outcome.
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Time frame: 12 months
Assessment of medium and long-term objectives using Goal Attainment Scaling (GAS scale).
Assessment of medium and long-term objectives using Goal Attainment Scaling (GAS scale). Higher scores mean a better outcome.
Time frame: 12 months
Number of adverse events.
Number of adverse events.
Time frame: 12 months