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

SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Drug: Botulinum Toxin A; Procedure: spastic hand sugery

Detailed Description

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
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pedro Hernández-Cortés, MD PhD; Phone Number: 958240721; Email: phc@ugr.es

Study Locations

• Spain
  • Granada, Spain, 18016
    • Recruiting
    • University of Granada
    • Contact: Pedro Hernández-Cortés, MD PhD; Phone Number: 958240721; Email: phc@ugr.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; Patients who meet the inclusion criteria and who will be treated with botulinum toxin (1 injection/4months).	Drug: Botulinum Toxin A; 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.
Experimental: Group II; Patients who meet the inclusion criteria and who will be treated by surgery.	Procedure: spastic hand sugery; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Quality of life by Newcastle Stroke-Specific Quality of Life Measure	is a specific questionnaire to measure the QoL of patients who suffered a stroke. It was developed and validated by Buck et al. It is different from other questionnaires because it includes domains of vision, cognition and communication, and it can used for patients with ischaemic or haemorrhagic stroke and motor aphasia.	t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome by Asworth scale	It measures the degree of spasticity from 0 to 5. Significant improvement of at least 1 of the 5 joints evaluated (elbow, forearm, wrist, thumb, fingers) will be considered a positive result.	t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Functional outcome by House hand function scale	Scale of hand function with 10 degrees of capability	t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Functional outcome by Fugl-mayer scale	is the first quantitative evaluative instrument for measuring sensorimotor stroke recovery, based on Twitchell and Brunnstrom's concept of sequential stages of motor return in the hemiplegic stroke patient.	t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Functional outcome by GAS score	5-grade scale for the domains hygiene, esthetics and pain. Krasny-Pacini y cols, 2013	t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Carer Burden by Carer Burden Score	Scores the caregiver's degree of difficulty for 4 basic activities (nail clipping, palm grooming, armpit grooming, arm dressing) on a 5-point Likert scale.	t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Pain by Visual Analogue Scale	A tool used to help a person assess the intensity of certain sensations and feelings, such as pain. The visual analogue pain scale is a straight line where one end means no pain and the other end means the worst pain imaginable. The patient marks a point on the line that matches the amount of pain he or she feels.	t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Sleep health by SATED scale	5 questions scale about satisfaction, alertness, timing, efficiency and duration of sleep to know the sleep health of patients. Higher scores (0-10) mean better sleep health.	t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Anxiety and depression by HADS scale	Includes 14 items, with scores from 0 to 3 (higher scores reflect greater severity of symptomatology).	t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)
Activity, structure and brain function by MRI	Functional Magnetic Resonance Imaging (fMRI) at rest and with the patient's repeated attempt to extend the elbow and wrist. Anatomical and functional volumes shall be obtained by MRI and fMRI imaging, using a Siemens Prisma 3T functional MRI.	t0 (basal assesment) t1 (6 months evaluation) t2 (12 months evaluation)

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; surgery; botulinum toxin; spastic hand
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: PI20/01574

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No