Track topics on Twitter Track topics that are important to you
Upper limb spasticity is currently mainly managed with local toxin treatments. Recent studies suggested combining botulinum toxin injections with splinting to optimise rehabilitation in spastic patients. However, one study focused exclusively on lower limb spasticity, the second on elbow flexor hypertonia, and the last on wrist and finger spasticity in children.
A study was performed in adult patients with upper limb spasticity treated with botulinum toxin injections used as primary objective the tolerance for dynamic splinting. The authors noted that the need for botulinum toxin was reduced in 2 patients out of 6. No study has been conducted to date on the splinting + toxin combination in adults.
Another study showed that stretching sessions over 2 weeks of a muscle just given botulinum toxin helped improve the toxin's efficacy 2, 6 and 12 weeks after the injection. For this reason, rehabilitation teams routinely prescribe 10 sessions of physiotherapy for 15 days after botulinum treatment.
Based on this principle, we hypothesise that dynamic night splinting applied just after botulinum toxin treatment may also increase the toxin's efficacy. We chose a dynamic splint providing continuous stretching of the wrist and fingers in extension whilst allowing active flexion. Night splinting is thought to promote optimal functional use of the paretic upper limb during the day and thus prevent learned non-use, which could worsen the spasticity.
Each patient will receive treatment cycles, whose results will be compared, so that each patient will act as his/her own control. The evaluation will be based on the Tardieu scale chosen for its greater inter-individual reproducibility and greater reliability to measure spasticity.
The degree of extension of wrist and fingers provided by the splint will be adjusted to the patient's clinical condition with the elastic tensioners. The purpose of the splint is to maintain the stretch beyond the Tardieu spasticity angle at fast speed (V3) without reaching maximum extension, which could be harmful.
This protocol is designed to determine whether dynamic night hand splinting combined with botulinum toxin injections will improve botulinum antispastic efficacy in adults with brain damage.
This prospective, multicentre, randomised, evaluation-blinded, crossover, pilot study, will include different treatment cycles: a control cycle (toxin alone) and a study cycle (toxin + splinting).
It will be conducted in two sites: CHU de Reims and UGECAM de Charleville Mézières.
The study population will include patients with upper limb spasticity associated with functional impairment and/or pain. To be included, the patients must be non-naïve to botulinum toxin, with a period of at least 4 months since the last toxin injections.
Each patient will be given botulinum toxin injections in the hypertonic muscles of his/her upper limb at the beginning of each cycle, i.e. on D0 Phase 1 (D0P1) and D0 Phase 2 (D0P2). This means each patient will receive two sets of injections at 5-month interval for the whole duration of the study.
1. If the effect of the toxin is still present at 5 months (W20), the visit for the following cycle may be delayed to ensure that both cycles are comparable (as per routine practice).
2. If the effect is still present at the end of the second cycle, the patient follow-up will be extended until the end of the effect.
As this is the first study of its type, the required number of subjects cannot be calculated and the decision was taken to conduct a pilot study. The required number of patients has been set at 30 for reasons of clinical relevance and study site capacity.
The patients will be randomised centrally into two arms of 15 patients each:
- Arm A: control cycle (toxin alone) followed by study cycle (toxin + splinting)
- Arm B: study cycle (toxin + splinting) followed by control cycle (toxin alone) The second set of toxin injections will be performed 5 months after the first set. As the effect of the toxin lasts 12 to 20 weeks maximum, this interval ensures that the effect of the first injections will have worn off before the second set of injections is given.
Botulinum toxin will be administered under electrical stimulation guidance to improve the accuracy of the injections in the muscles. Dysport® doses will be adjusted to the muscle group being treated.
The post-injection rehabilitation protocol will be identical for both cycles, and include 10 sessions of physiotherapy to stretch the injected muscles (as per routine practice). The prescription of these sessions will be standardised. These daily sessions will start the day following the botulinum injections, and continue 5 times a week for 2 weeks for both treatment phases.
For the study cycle, the splint will be worn only at night (8.00 pm to 8.00 am) for 4 weeks, starting on the first evening after the toxin injection.
Any previous and on-going drug treatment will also be recorded. Concomitant oral antispastic treatments will be authorised provided they were initiated prior to the patient's inclusion in the study, and that dosage regimens remain unchanged.
The investigator performing the evaluations will be blinded to the treatment cycle, i.e. he/she will not know which treatment cycle the patient is currently in. Therefore, the evaluating, injecting and splint-referring physicians will be three different people. To limit potential biases, these 3 persons will remain the same during all the study for all the patients included.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Upper Limb Spasticity Associated With Functional Impairment and/or Pain
botulinum toxins (Dysport°) alone, orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined
Chu de Reims
CHU de Reims
Published on BioPortfolio: 2016-09-06T16:08:21-0400
The objective of this study is to compare the field of effects of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as mo...
The objective of this study is to compare the action halos of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more d...
Botulism is a severe form of food poisoning caused by bacteria. This bacteria produces several toxins one of which is botulinum toxin A. This toxin causes the symptoms of food poisoning....
The main purpose of this study is to determine the effectiveness and safety of one dose of botulinum toxin type A (Dysport) associated with rehabilitation treatment on pain control in pati...
The aim of this clinical study is to investigate the efficacy and safety of Dysport® in patients with early onset of upper limb spasticity within 2-12 weeks after stroke.
This review explores current evidence to demonstrate that botulinum neurotoxins (BoNTs) exert antipruritic effects. Both experimental and clinical conditions in which botulinum neurotoxins have been a...
Diseases triggered by microorganisms can be controlled by vaccines, which need neutralizing antigens. Hence, it is very crucial to identify extremely efficient immunogens for immune prevention. Botuli...
The effects of botulinum toxin are transient, and repeat injections are required in children with lower-limb spasticity. However, the efficacy of botulinum toxin in patients who have received previous...
Botulinum neurotoxins (BoNTs) are potent bacterial toxins mostly produced by genetically diverse clostridial strains. Recently, BoNT variants have been reported in non-clostridial strains. In this iss...
Hundreds and hundreds of bacterial protein toxins are presently known. Traditionally, toxin identification begins with pathological studies of bacterial infectious disease. Following identification an...
A serotype of botulinum toxins that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25.
A species of anaerobic, gram-positive, rod-shaped bacteria in the family Clostridiaceae that produces proteins with characteristic neurotoxicity. It is the etiologic agent of BOTULISM in humans, wild fowl, HORSES; and CATTLE. Seven subtypes (sometimes called antigenic types, or strains) exist, each producing a different botulinum toxin (BOTULINUM TOXINS). The organism and its spores are widely distributed in nature.
Subtype of CLOSTRIDIUM BOTULINUM that produces botulinum toxin type C which is neurotoxic to ANIMALS, especially CATTLE, but not humans. It causes dissociation of ACTIN FILAMENTS.
Subtype of CLOSTRIDIUM BOTULINUM that produces botulinum toxin type D which is neurotoxic to ANIMALS, especially CATTLE, but not humans.
Subtype of CLOSTRIDIUM BOTULINUM that produces botulinum toxin type B which is neurotoxic to humans and animals.
A joint is where two or more bones come together, like the knee, hip, elbow, or shoulder. Joints can be damaged by many types of injuries or diseases, including Arthritis - inflammation of a joint causes pain, stiffness, and swelling with ...
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...