SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS: RANDOMIZED TRIAL

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental44 enrolled

Overview

We present a research project in the form of a controlled clinical trial with the aim of analyzing and demonstrating whether the surgical treatment of upper limb spasticity is an effective and efficient measure to improve dependence and quality of life perceived by patients with sequelae of stroke and therefore, should be included in the therapeutic protocols, in which it is not usually contemplated, as a complement or alternative to traditional treatment with botulinum toxin, rehabilitation and occupational therapy.

Cerebrovascular accident (CVA) or "stroke" is the leading cause of permanent disability in adulthood and many patients require lifelong medical treatment and assistance from other people for the development of their daily activities. The repercussion in the family, professional, labor and social fields is enormous, producing a very important economic expense. The usual treatment of spastic upper limb secondary to stroke is rehabilitation, occupational therapy and periodic injection of botulinum toxin, and surgical correction is not usually considered. A two-arm Randomized Clinical Trial \[surgical treatment (n=22) vs. botulinum toxin (n=22)\] is proposed with the aim of investigating the efficacy and efficiency of surgery for upper limb spasticity with respect to treatment with botulinum toxin in patients with established spastic sequelae after stroke. We will evaluate the effect on functionality and "hygienic" changes; the impact on quality of life, sleep quality, anxiety and depression; as well as on brain activity by Functional Magnetic Resonance Imaging, at baseline and at 6 and 12 months follow-up. The health and care costs of the established groups of patients will also be evaluated. This research is framed in the context of chronic diseases, aging and patients with functional and mobility difficulties. The results of this work are expected to have a great impact due to the high prevalence of the disease, the severe disability it causes, and the number of patients who would benefit, in addition to the savings in healthcare resources. The incorporation of surgery into stroke care would change the current treatment paradigm, favoring the formation of multidisciplinary teams for the treatment of the disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

spastic hand sugeryPROCEDURE

Deformity correction can be performed with single event multilevel surgery, using a combination of soft tissue releases and lengthening, tendon transfers and joint stabilization procedures. In addition, selective and supraselective neurectomies can also be performed.

Botulinum Toxin ADRUG

Treatment consists of periodic injections of the toxin into the spastic muscles. It causes reversible chemical denervation by preventing the release of acetylcholine vesicles at the neuromuscular junctions of the affected muscles.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients of legal age, with spasticity in the upper limb due to stroke, with a minimum evolution time of 12 months, who, after being informed orally and in writing of the objectives of the study, sign the informed consent form (themselves or their legal representatives). Exclusion Criteria: * Absence of consent, refusal of possible surgical treatment, stroke evolution time of less than 12 months, anaesthetic risk (ASA) class IV or higher, presence of involuntary movements, inability to respond adequately to surveys, deformities that cannot be addressed by surgical treatment or inability to follow up for at least one year.

Outcomes

Primary Outcomes

Quality of life by 36-Item Short Form Survey Instrument (SF-36)

SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used.