| Methods |
Randomised double blind cross‐over trial. Randomisation by random number table performed by pharmacists blind to patients and assessors. |
| Participants |
25 SCI pts: 22 male and 3 female (neurological level, completeness and autonomy not described), with spasticity due to SCI. Length from onset: 1 month ‐ 26 years (median 7 years). Age: 21 ‐ 60 years. Inclusion criteria: age above 18 years, spasticity due to SCI, not responsive to antispastic drugs. Exclusion criteria: pregnancy, history of renal disease, absence of spasms or rigidity. |
| Interventions |
Placebo or gabapentin 400 mg x 3 daily for 48 hours, added to usual medications. 11 day washout interval. |
| Outcomes |
Assessed at baseline (day 1), day 3, 15 and 17, at the same time and within 5 hours from the last drug administration.
a) Subjective evaluation of spasm by Likert six‐point scale; b) Ashworth scale (1 ‐ 5); c) Muscle stretch reflexes (0 ‐ 4); d) Clonus (0 ‐ 3); e) Response to noxious stimuli (0 ‐ 3). |
| Notes |
Possible interference of concomitant antispastic treatment. No functional outcomes. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
Adequate |
