Stewart et al. 1991
Canada
PEDro = 6
RCT
N (enrolled) = 12
N (completed) = 9
Not combined with training |
Population: 6 subjects with Frankel level A/B, 3 subjects with Frankel level C/D; age: 19–57 years; C7-T10 lesion level; 1–10 yrs post-injury.
Treatment: Double-blind, placebo-controlled, crossover design: Two periods of 4 weeks of medication (Clonidine (up to 0.1–0.5 mg daily) or Placebo, randomly assigned) separated by a 2 week washout period.
Outcome measures: Kinematic measures during body weight support treadmill locomotion, spasticity (no statistical analysis). |
One Frankel C/D patient experienced improvement in treadmill locomotor function resulting from Clonidine and associated with reduction in spasticity. Other 2 Frankel C/D patients showed minimal changes in locomotion with Clonidine. Clonidine did not elicit locomotor activity in the Frankel A/B patients, but there were reductions in stretch reactions and clonus during assisted locomotion.
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Mild side effects included dryness of eyes and mouth, lethargy, hypotension, and constipation (8/9). Moderate to severe side effects included lethargy and constipation (2/9).
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Remy-Neris et al. 1999
France
Downs & Black = 16
Prospective controlled trial
N = 11
N with SCI = 8
Not combined with training |
Population: 11 subjects with incomplete paraplegia; age: 25–66 years; 6 months to 16 yrs post-injury.
Treatment: 3 doses of 15–90 μg Clonidine or placebo (0.6 ml saline) by lumbar puncture or intra-thecally. Each injection separated by a minimum of 3 days.
Outcome measures: Spatiotemporal gait data, Ashworth scores, soleus H-reflex, and polysynaptic flexion reflexes recorded before and every hour for 4–6 hours after injection. |
3 of 8 ambulatory subjects had significantly greater maximum over ground walking speed with Clonidine. These subjects were more severely impaired and had shorter times post-injury. Spasticity was significantly reduced after injection in all subjects. No significant change in soleus H-reflex. Dose-dependent decrease in early latency of poly-synaptic flexion reflexes. Effects of intrathecal Clonidine were dose dependent and subject-specific.
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None reported.
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Norman et al. 1998
Canada
Downs & Black = 13
Pre-post
N=12
Not combined with training |
Population: 12 subjects; Frankel C/D; age: 19–35 yrs; C4-T12 lesion level; 1.1–5.3 yrs post-injury.
Treatment: 3 different oral tablets in order of convenience: Clonidine (≤0.25 mg/day) or Cyproheptadine (≤24 mg/day) or Baclofen (≤80 mg/day): each drug trial had incremental increase to maximum dose and stable dosing over 3 weeks followed by incremental decrease from maximum dose and washout over 2 weeks.
Outcome measures: Surface EMG and kinematic gait analysis during treadmill walking. No statistical analysis. |
7/12 subjects had evaluations of all 3 drugs; adverse effects for 4/5 subjects prevented completion of all conditions; one subject dropped-out. Clonidine resulted in ↑ maximal treadmill speed and a generally more upright posture. Cyprohyeptadine resulted in↓ need for assistance, ↑ in maximum treadmill speed and ↓ clonus. Baclofen resulted in minor changes in walking. The combination of Clonidine and Cyproheptadine resulted in ↑ in maximum treadmill speed, ↓ assistance with stepping Subjects with greater functional impairment showed greatest effects from Clonidine or Cyproheptadine.
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Clonidine: dryness of eyes (7/12); increased urinary frequency (4/12); fatiguability (4/12); light-headedness/dizziness (4/12); constipation (3/12); decreased urinary urgency (2/12); increased appetite (2/12); numbness (1/12); altered sexual function (1/12); and nausea (1/12). Cyproheptadine: increased appetite (5/12), headache/nausea (2/12), fatiguability (2/12), subjective decrease in strength (1/12), increased urinary frequency (1/12), and skin rash (1/12). One or more subjects discontinued medication and/or withdrew study because of adverse side effects (headache/nausea, skin rash). Baclofen: fatiguability (3/12), drowsiness (3/12), subjective decrease in strength (2/12), increased spasms (2/12), and subjective decrease in sensation (1/12). One or more subjects discontinued baclofen early and/or dropped out of the study due to the adverse side effects of fatiguability/decreased concentration and increased spasms.
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