The purpose of this double-blinded, placebo-controlled study is to test if treatment with Botulinum toxin-A is effective in reducing chronic muscle-related pain in adults with spastic cerebral palsy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
Intramuscular injections in spastic muscle with regional muscle-related pain
Intramuscular injections in spastic muscle with regional muscle-related pain
Department of Rehabilitation Medicine at Danderyd Hospital AB
Danderyd, Sweden
Astrid Lindgren's Children's Hospital at Karolinska University Hospital
Stockholm, Sweden
Pain intensity
Proportion of responders derived as reduction of intensity of pain of ≥2 points on the Numerical Rating Scale (NRS) at Visit 3 (six weeks after treatment) compared to baseline.
Time frame: Six weeks after treatment
Use of other analgesic treatment
Categories of change in the use of analgesic treatments, derived as Increase, No change, or Decrease at Visit 3 (six weeks after treatment), compared to baseline.
Time frame: Six weeks after treatment
Pain interference
Proportion of responders derived as a reduction in mean interference score of ≥1 on the Brief Pain Inventory (BPI-SF) at Visit 3 (six weeks after treatment) compared to baseline.
Time frame: Six weeks after treatment
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