| Outcomes | Illustrative comparative risks (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | |
|---|---|---|---|---|---|
| Risk pre-operative | Risk with Intrathecal baclofen (post-operative) | ||||
|
Walking - household or community ambulation Follow-up: 4 years | 625 per 1,000 |
750 per 1,000 (513 to 1,000) |
RR 1.20 (0.82 to 1.77) |
24 (1 observational study) | Very low1 |
|
Gross motor function GMFM total score Scale from: 0 to 100 Follow-up: 1 year | The mean gross motor function was 55.22 % | The mean gross motor function in the intervention group was 2.34 % higher (2.34 lower to 7.02 higher) | - |
9 (1 observational study) | Very low2 |
|
Tone upper extremity (ITB bolus 100 micrograms) Ashworth scale Scale from: 1 to 5 Follow-up: 4 hours | The mean tone upper extremity (ITB bolus 100 micrograms) was 1.64 | The mean tone upper extremity (ITB bolus 100 micrograms) in the intervention group was 0.23 lower (0.71 lower to 0.25 higher) | - |
8 (1 RCT) | Low3,4 |
|
Tone lower extremity (ITB bolus 100 micrograms) Ashworth scale Scale from: 1 to 5 Follow-up: 4 hours | The mean tone lower extremity (ITB bolus 100 micrograms) was 2.75 | The mean tone lower extremity (ITB bolus 100 micrograms) in the intervention group was 1.4 lower (2.44 lower to 0.36 lower) | - |
8 (1 RCT) | Low2,3 |
|
Tone lower extremity (ITB continuous infusion) Ashworth scale Scale from: 1 to 5 Follow-up: range 1 years to 5 years | The mean tone lower extremity (ITB continuous infusion) ranged from 3.16 to 3.4 | The mean tone lower extremity (ITB continuous infusion) in the intervention group ranged from 1.90 lower (2.66 to 1.14 lower) to 1.16 lower (1.45 to 0.87 lower) | - |
38 (2 observational studies) | Very low2,5 |
|
Tone upper extremity (ITB continuous infusion) Ashworth scale Scale from: 1 to 5 Follow-up: 1 years | The mean tone upper extremity (ITB continuous infusion) was 3 | The mean tone upper extremity (ITB continuous infusion) in the intervention group was 1.3 lower (2.15 lower to 0.45 lower) | - |
13 (1 observational study) | Very low2 |
| HRQOL - not reported | - | - | - | - | - |
| Pain - not reported | - | - | - | - | - |
|
Adverse events (ITB continuous infusion) - catheter or pump infections Follow-up: range 4 to 5 years | Rate ranged from 4.2 to 8% | - |
49 (2 observational studies) | Very low1,4 | |
|
Adverse events (ITB continuous infusion) - catheter disconnection / breakage Follow-up: range 4 years to 5 years | Rate ranged from 4.2% to 17% | - |
55 (3 observational studies) | Very low1,4 | |
|
Adverse events (ITB continuous infusion) - Constipation Follow-up: range 1 years to 5 years | Rate ranged from 4% to 15% | - |
38 (2 observational studies) | Very low1,4 | |
|
Adverse events (ITB continuous infusion) - Anxiety and depression Follow-up: 5 years | Rate was 8% | - |
13 (1 observational study) | Very low1,4 | |
|
Adverse events (ITB continuous infusion) - Seizures Follow-up: 1 years | Rate was 15% | - |
13 (1 observational study) | Very low1,4 | |
| Satisfaction - not reported | - | - | - | - | - |
| Concurrent medications - not reported | - | - | - | - | - |
CI: confidence interval; GMFM: gross motor function measure; HRQOL: health related quality of life; ITB: intrathecal baclofen; RR: risk ratio.
No comparator
Confidence interval includes one default MID threshold
Intrathecal bolus injection rather than implanted pump
Number of participants <400
Extremity not reported in one of the studies
From: Management of abnormal muscle tone: neurosurgical procedures to reduce spasticity
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.