ABSTRACT
OBJECTIVE: To evaluate whether botulinum toxin can decrease the burden for caregivers of long term care patients with severe upper limb spasticity. METHOD: This was a double-blind placebo-controlled trial with a 24-week follow-up period. SETTING: A 250-bed long term care hospital, the infirmary units of 3 regional hospitals, and 5 care and attention homes. PARTICIPANTS: Participants included 55 long term care patients with significant upper limb spasticity and difficulty in basic upper limb care. INTERVENTIONS: Patients were randomized into 2 groups that received either intramuscular botulinum toxin A or saline. MAIN OUTCOME MEASURES: The primary outcome measure was provided by the carer burden scale. Secondary outcomes included goal attainment scale, measure of spasticity by modified Ashworth score, passive range of movement for shoulder abduction, and elbow extension and finger extension. Pain was assessed using the Pain Assessment in Advanced Dementia Scale. RESULTS: A total of 55 patients (21 men; mean age = 69, SD =18) were recruited. At week 6 post-injection, 18 (60%) of 30 patients in the treatment group versus 2 (8%) of 25 patients in the control group had a significant 4-point reduction of carer burden scale (P < .001). There was also significant improvement in the goal attainment scale, as well as the modified Ashworth score, resting angle, and passive range of movement of the 3 regions (shoulder, elbow, and fingers) in the treatment group which persisted until week 24. There were also fewer spontaneous bone fractures after botulinum toxin injection, although this did not reach statistical significance. No significant difference in Pain Assessment in Advanced Dementia scale was found between the 2 groups. No serious botulinum toxin type A-related adverse effects were reported. CONCLUSION: Long term care patients who were treated for upper limb spasticity with intramuscular injections of botulinum toxin A had a significant decrease in the caregiver burden. The treatment was also associated with improved scores on patient-centered outcome measures.
