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. 2013 Jun 20;3(6):e002771.
doi: 10.1136/bmjopen-2013-002771.

Results from the Upper Limb International Spasticity Study-II (ULISII):a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management

Lynne Turner-Stokes  1 , Klemens Fheodoroff  2 , Jorge Jacinto  3 , Pascal Maisonobe  4
Affiliations

Results from the Upper Limb International Spasticity Study-II (ULISII):a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management

Lynne Turner-Stokes et al. BMJ Open. .

Abstract

Objective: To describe real-life practice and person-centred outcomes in the treatment of poststroke upper limb spasticity with botulinum toxin A (BoNT-A).

Design: Observational, prospective study.

Setting: 84 secondary care centres in 22 countries.

Participants: 456 adults (≥18 years) with poststroke upper limb spasticity treated with one cycle of BoNT-A.

Methods/outcomes: Muscle selection, BoNT-A preparation, injection technique and timing of follow-up were conducted according to routine practice for each centre.

Primary outcome: achievement of the patient's primary goal for treatment using goal-attainment scaling (GAS). Measurements of spasticity, standardised outcome measures and global benefits were also recorded.

Results: The median number of injected muscles was 5 (range 1-15) and the most frequently injected muscles were the long finger flexors, followed by biceps and brachioradialis. The median (range) follow-up time was 14 (2.6 to 32.3) weeks. The common primary treatment goals were passive function (132 (28.9%)), active function (104 (22.8%)), pain (61 (13.4%)), impairment (105 (23%)), involuntary movement (41 (9%)) and mobility (10 (2.2%)). Overall, 363 (79.6%) (95% CI 75.6% to 83.2%) patients achieved (or overachieved) their primary goal and 355 (75.4%) (95% CI 71.2% to 79.2%) achieved their secondary goal. Mean (SD) change from baseline in GAS T-scores was 17.6 (11.0) (95% CI 16.4 to 18.8; p<0.001). GAS T-scores were strongly correlated with global benefit and other standard measures (correlations of 0.38 and 0.63, respectively; p<0.001).

Conclusions: BoNT-A demonstrated a clinically significant effect on goal attainment for the real-life management of upper-limb spasticity following stroke. The study confirms the feasibility of a common international data set to collect systematic prospective data, and of using GAS to capture person-centred outcomes relating to passive and active functions and to pain.

Registration: ClinicalTrials.gov identifier: NCT01020500.

Keywords: botulinum toxin A; goal attainment scaling; post-stroke spasticity; stroke rehabilitation.

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References

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