Thimineur 2004.
Methods | Case series Duration: 36 months |
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Participants | N = 38 enrolled Primary condition: Not reported. Likely back pain since Oswestry Disability Index (ODI) was administered. Baseline pain score: 8.4 (SD 1.4)/10 VAS Time since onset: 6.8 (SD 4) years Mean age: 46.1 (SD 12) years Female: Not reported Previous opioid analgesics: All patients had prior opioid exposure, but with dose‐limiting adverse events |
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Interventions | Initial doses not reported for any drug Intrathecal morphine (n = 9), Titrated to mean 10.8 mg/day Intrathecal Dilaudid (n = 21), Titrated to mean 13.5 mg/day Intrathecal fentanyl (n = 24), Titrated to mean 664 ug/day Intrathecal clonidine (n = 23), Titrated to mean 378 ug/day Intrathecal baclofen (n = 2), Titrated to mean 120 ug/day Intrathecal bupivacaine (n = 1), Titrated to 15.0 mg/day Intrathecal methadone (n = 1), Titrated to 10.0 mg/day Supplemental analgesics: All patients received other pain therapies, such as oral and transdermal medications, therapeutic injections, and physical therapy |
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Outcomes | Adverse Events Pain, continuous Quality of life Function |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Comparability of patients at baseline and follow‐up (continuous data) All outcomes | Low risk | Attrition rate relatively low |
Selection method random or consecutive | Unclear risk | Unclear whether either all or consecutive patients were invited |
Prospective | Low risk | Prospective |
Free from confounding treatment(s) | High risk | All patients had additional pain therapies |
Patient compliance monitored and reported at at least 85%? | Low risk | Pump administration |
Attrition and right censoring less than 15% (continuous data) All outcomes | Low risk | Lower than 15% |
Funding from a source without financial conflict of interest? | High risk | Funding by Medtronic |