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Questionnaire about the adverse events and side effects following botulinum toxin A treatment in patients with cerebral palsy
2015 (English)In: Toxins, ISSN 2072-6651, E-ISSN 2072-6651, Vol. 7, no 11, p. 4645-4654Article in journal (Refereed) Published
Abstract [en]

Botulinum toxin A (BoNT-A) injections for treatment of spasticity in patients with cerebral palsy (CP) have been used for about two decades. The treatment is considered safe but a low frequency of adverse events (AE) has been reported. A good method to report AEs is necessary to verify the safety of the treatment. We decided to use an active surveillance of treatment-induced harm using a questionnaire we created. We studied the incidence of reported AEs and side effects in patients with CP treated with BoNT-A. We investigated the relationship between the incidence of AEs or side effects and gender, age, weight, total dose, dose per body weight, Gross Motor Function Classification System (GMFCS) and number of treated body parts. Seventy-four patients with CP participated in our study. In 54 (51%) of 105 BoNT-A treatments performed in 45 (61%) patients, there were 95 AEs and side effects reported, out of which 50 were generalized and/or focal distant. Severe AEs occurred in three patients (4%), and their BoNT-A treatment was discontinued. Consecutive collection of the AE and side-effect incidence using our questionnaire can increase the safety of BoNT-A treatment in patients with CP.

Place, publisher, year, edition, pages
MDPI, 2015. Vol. 7, no 11, p. 4645-4654
Keywords [en]
botulinum toxin type A, cerebral palsy, safety, adverse events, muscle spasticity
National Category
Surgery
Identifiers
URN: urn:nbn:se:umu:diva-120337DOI: 10.3390/toxins7114645ISI: 000365647700017PubMedID: 26561833Scopus ID: 2-s2.0-84946819557OAI: oai:DiVA.org:umu-120337DiVA, id: diva2:928525
Funder
Västerbotten County CouncilAvailable from: 2016-05-16 Created: 2016-05-16 Last updated: 2023-02-27Bibliographically approved
In thesis
1. Upper limb assessment and treatment in cerebral palsy
Open this publication in new window or tab >>Upper limb assessment and treatment in cerebral palsy
2023 (English)Doctoral thesis, comprehensive summary (Other academic)
Alternative title[sv]
Bedömning och behandling av övre extremitet hos patienter med cerebral pares
Abstract [en]

Cerebral palsy (CP) is a heterogeneous group of neurological disorders caused by fetal or infant brain damage that often involves deficits in upper limb (UL) posture and function. Knowledge about effective methods of assessment and treatment of UL in CP is not extensive. In this thesis, different aspects of these two are explored.

In Paper I we retrospectively investigated the effect of a long-term treatment regime developed in Västerbotten county habilitation service. The treatment regime included intramuscular injections of botulinum toxin type A (BoNT-A) combined with occupational therapy (OT) and movement training. The results of passive extension of the wrist with fingers extended and the assessment of hand function in children with severe hand function impairment (initially House functional classification 0-1) were analyzed over time. Twenty-five children were divided into 3 groups depending on the treatment regime start age (before or after the age of 7) and treatment regime availability. We found significantly worse passive extension of the wrist with fingers extended in children who did not have a chance to benefit from therapy in early childhood. Additionally, an improvement in the passive movement of the wrists was noted in children who completed the treatment regime before the age of 7. Regarding hand function, a significant difference was found between children who received treatment in early childhood and those who received treatment as adolescents.

The injections of BoNT-A in CP are common, however the monitoring of eventual side effects and adverse events (AEs) after this treatment is difficult to perform in clinical practice. To facilitate this process, we created a new, no previously validated questionnaire (Paper II). The questionnaire was given to patients or their caregivers to be completed after each BoNT-A treatment. 94% of participants returned the questionnaire. 80 % were filled in completely which proves the effectiveness of the applied form and the ease of its use in clinical practice. 61% of patients reported one or more different AEs or sides effects. In addition, we analyzed the risk for generalized and focal distal AEs reported by 38% of patients. Those may indicate the spread of BoNT-A toxin to the whole body, therefore requiring special attention. We found that females had a 1.899 relative risk with significant association (p=0.029) of reporting generalized and focal delayed AEs compared to males. The use of the questionnaire helped to make the decision to change or discontinue BoNT-A injections in 8 cases (11%).

In some patients with dyskinetic type of CP (DCP) treated with BoNT-A to diminish the external rotation posture of the shoulders, a loss of treatment effect was observed, which contributed to the need to look for another method of treatment. In paper III, a surgical method to manage the external rotation posture of the shoulders is presented. The surgical procedure consists of weakening the strength of the externally rotating muscles by cutting the attachment of one of them (release of the posterior deltoid) and complete denervation of the other (denervation of the infraspinatus). The third shoulder external rotator (teres minor) remains intact. The results of this procedure performed in 7 shoulders in 6 patients (age 14-24) were analyzed using satisfaction questionnaire and pre-/postoperative video-recordings. Five of 6 patients were very satisfied with the treatment, one was neither satisfied nor dissatisfied. Four patients had an obvious improvement in their shoulder position confirmed on video recordings. In one, overcorrection in the form of internal shoulder rotation was observed.

Assessment of the thumb in CP is important as the thumb impairment plays a crucial role in hand grip function. Paper IV presents a new tool called CP-thumb score, which addresses the occupational therapists to follow the changes in the thumb function and its posture. CP-thumb score has two parts: descriptive and score of the thumb’s CMC joint radial abduction. Thirty thumbs in 19 patients with all types of CP were assessed with CP-thumb score. All assessments were made based on available video recordings. Additionally, all thumbs were assessed using the House’s thumb-in-palm classification which has been shown to be unreliable. These two thumb assessments were compared with each other.

Place, publisher, year, edition, pages
Umeå: Umeå University, 2023. p. 77
Series
Umeå University medical dissertations, ISSN 0346-6612 ; 2229
Keywords
Cerebral palsy, upper limb, botulinum toxin type A, upper limb surgery, side effects, thumb assessment
National Category
Surgery
Research subject
hand surgery 
Identifiers
urn:nbn:se:umu:diva-205144 (URN)978-91-7855-962-6 (ISBN)978-91-7855-963-3 (ISBN)
Public defence
2023-03-24, Hörsal E04, Byggnad 6E, Norrlands universitetssjukhus, Daniel Naezéns väg, Umeå, 09:00 (English)
Opponent
Supervisors
Available from: 2023-03-03 Created: 2023-02-23 Last updated: 2023-02-27Bibliographically approved

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Blaszczyk, IzabelaLjungberg, ChristinaWiberg, Mikael

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