Armstrong 1997.

Methods	Phase 1: trial dose 25 mcg baclofen to determine whether beneficial and whether excessive sedation produced. A further trial with 10 mcg dose performed if the patient sedated with 25 mcg dose. If evidence of benefit without significant side effects, patients proceeded to next phase Phase 2: double‐blind, placebo‐controlled trial of baclofen or saline Phase 3: code broken, pump implantation in individuals who benefited, open‐label, long‐term infusion of intrathecal baclofen
Participants	19 children with spasticity, of whom 10 had spastic cerebral palsy
Interventions	Subarachnoid catheter with subcutaneous access port; escalating dose of intrathecal baclofen (dose and bolus versus continuous infusion not specified), or intrathecal saline
Outcomes	Ashworth score upper and lower limbs
Notes	Ashworth score results of randomised phase not reported. Author unable to supply this data.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation or methods relating to this not described.
Allocation concealment (selection bias)	Unclear risk	No relevant detail recorded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No relevant detail recorded.
Selective reporting (reporting bias)	Unclear risk	No relevant detail recorded.
Blinding (performance bias and detection bias)	Low risk	Study described as "double blind."
Potential for carry‐over effect in cross‐over study design	Low risk	Washout period of at least two to four days