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Rintala et al. 2007;
USA
PEDro=10
RCT
N=22
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Population: SCI: Mean age = 42.6 yrs; Gender: males = 20, females = 2; Level of injury: paraplegia = 7, tetraplegia = 12; Severity of injury: AIS A-C = 19, D = 3; Time since injury = 12.6 yrs; Duration of pain = 7.3 yrs.
Treatment: Patients were randomized into 1 of 6 groups: 1) gabapentin-amitriptyline-diphenhydramine (GAD)(n=7), 2) GDA (n=6), 3) AGD (n=6), 4) ADG (n=6), 5) DGA (n=7), 6) DAG (n=6). Each drug was administered for 9 wks with 1 washout week before and after each drug treatment, for a total of 31 weeks. The maximum doses were 50mg, 3x/day for amitriptyline; 1200mg, 3x/day for gabapentin; 25mg, 3x/day, diphenhydramine (control).
Outcome Measures: Effectiveness of amitriptyline, diphenhydramine, gabapentin on pain management.
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- Amitriptyline was significantly more effective than diphenhydramine at 8 weeks, in subjects with high (≥ 10) baseline Center for Epidemiologic Studies Depression Scale-Short Form (CESD-SF) scores (p=0.035).
- No significant difference was seen at 8 weeks in subjects with high (≥ 10) baseline CESD-SF scores in :
- Effectiveness of amitriptyline over gabapentin (p=0.061).
- Effectiveness of gabapentin over diphenhydramine (p=0.97).
- Subjects with low (< 10) baseline CESD-SF scores showed no significant difference among the medications.
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Cardenas et al. 2002; USA
PEDro=9
1 RCT
N=84
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Population: Mean age = 41 yrs; Gender: males = 80%, females = 20%; Level of injury: cervical, lumbar; Severity of injury: AIS: A-D; Time since injury = 169 mths.
Treatment: Subjects with chronic pain randomized to a 6 wk course of amitriptyline or placebo 1-2 hrs before bedtime.
Outcome Measures: Average pain measure (scale 0-10), SF-MPQ, BPI, CES-D scale, FIM.
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- There were no significant differences between the 2 groups at baseline and at the 6 week time period for any of the measures except satisfaction with life which showed higher scores for those in the placebo group (p=0.004).
- For those who remained on the two medications, it was noted that those in the amitriptyline group had significantly higher severity ratings for increased spasticity (p=0.005) than those in the control group.
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Davidoff et al. 1987;
USA
PEDro=6
RCT
Initial N=19; Final N=18
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Population: Mean age = 39 yrs; Gender: males = 16, females = 2; Time since injury = 49 mths.
Treatment: Subjects underwent a 2 week placebo lead-in period with a 6 week randomization to 150 mg trazodone per day or placebo.
Outcome Measures: MPQ, SPI, PAD
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- No significant differences were noted between the groups when looking at the MPQ, SPI, PAD.
- More subjects reported side effects in the experimental gr (p<0.05).
- More subjects in the placebo group completed the 8 wk study (p<0.01).
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