Spasticity Clinical Trial
Official title:
Influence of Physiotherapy on the Spastic Musculus Biceps Brachii Under Routine Botulinum Toxin Injection. - An Explorative MRI Study
Intramuscular application of botulinum toxin (BoNT) is used as a successful therapy of
muscle spasticity. Clinical practice shows, that even with the use of special guidance
techniques to increase accuracy of targeting, BoNT may spread to adjacent sites by
diffusion. This causes fluctuating treatment response, unintended side effects, and decrease
of effect due to production of antibodies. Hence, clinicians require increase of efficacy
and safety by dose reduction, improvement of injection technique, and additional treatment
strategies. Referring to this, animal model showed increased efficacy and decreased systemic
side effects of BoNT in the injected muscle after active or passive manipulation of muscle.
The mechanism of this effect remain unclear.
T2 and (Diffusion Tensor Imaging) DTI technique can evaluate the in-vivo distribution of
fluids in human skeletal muscle. In addition, it allows to differentiate denervated muscle
tissue, caused by BoNT injections, from surrounding unaffected muscle tissue.
Up to the investigators knowledge, neither a human, in vivo measurement of the influence of
passive muscle activity on the area of denervation, nor the primary, in-vivo distribution of
BoNT within spastic human muscle tissue, been evaluated.
The aim of this explorative study is:
- to monitor the inflow and regional distribution of the injection bolus by dynamic
T2-weighted-, DTI-sequences;
- to assess the effect of passive muscle exercise on the area of denervated, caused by
BoNT, measured by DTI-, T2-weighted and flair sequences.
The investigators hypothesize, that
- intramuscular denervation area, measured by DTI-, T2-weighted and Fluid Attenuated
Inversion Recovery (FLAIR) sequences, 3 weeks after routine BoNT injection, is
facilitated by passive muscle exercise;
- primary distribution of the injected BoNT bolus can be non-invasively monitored by
dynamic T2-, DTI- and T2 weighted sequences.
Therefore, in this investigator blinded, cross-over study, 6 patients suffering from upper
limb spasticity, including musculus biceps brachii, will be investigated. (Magnetic
Resonance Tomography) MRI of the musculus biceps brachii will be performed at two
consecutive, routine BoNT-injection days (baseline and week 16). Patients receive dosage as
clinically indicated, due to routine treatment. Patients will be randomised to receive
thirty minutes of physiotherapy of the affected arm, including exercise of the elbow
flexors, at one of the injection days (baseline, or week 16, respectively). In addition, MRI
will be repeated 3 weeks after injection.
- At baseline and week 16, dynamic T2-, T2-,and DTI weighted sequences will be performed
to monitor the injection of the BoNT-bolus. Immediate after MRI-scan, physiotherapy
will be performed. Patients, who were randomised to the non-treatment group at
baseline, will receive physiotherapy immediately after MRI at week 16.
- At week 3 and week 19, three weeks after BoNT injection, respectively, MRI will be
repeated. T2-and DTI- weighted and FLAIR- sequences will be performed.
;
Observational Model: Case-Crossover, Time Perspective: Prospective
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