Stajcic 1990.
Methods | A randomised, double‐blind, prospective, parallel group study | |
Participants |
Intervention: peripheral streptomycin + lidocaine Diagnostic criteria of patients included in the trial Internation Headache Society criteria, excluded those with pain relief for over 24 hours after test doses of lidocaine No remissions for at least 1 year To locate correct nerve at first visit gave lidocaine block 9 had had previous local surgery Age range 49 to 85 Severity Not available Duration of condition range years 1.2 to 29 years Number 9 Control: peripheral lidocaine Diagnostic criteria of patients included in the trial International Headache Society criteria, excluded those with pain relief for over 24 hours after test doses of lidocaine No remissions for at least 1 year To locate correct nerve at first visit gave lidocaine block 9 had had previous local surgery Age range 49 to 85 years Severity Not available Duration of condition mean (range) years 1.2 to 29 years Number 8 |
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Interventions |
Intervention: peripheral streptomycin + lidocaine Type of intervention 1 g streptomycin + 3 ml 2% lidocaine into trigger area weekly for 5 weeks Usual medication not changed Length of follow‐up (mean in months) Shortest 6 months Control: peripheral lidocaine Type of intervention 3 ml lidocaine into trigger area weekly for 5 weeks Usual medication not changed Length of follow‐up (mean in months) Shortest 6 months |
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Outcomes |
Primary outcome Pain relief measured at 1 week and 30 months following intervention Adverse events Nil reported |
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Notes | Randomised double‐blind trial in 18 patients with TN of varying duration. There are insufficient details to determine whether there is bias, whether the groups were comparable, no details of how outcomes measured, no details of follow up time on all patients. Initially the results suggested some improvement in those having streptomycin but longer follow‐up showed that this was not maintained. However, no details provided as to overall versus triggered branch relief or whether medication was stopped or reduced | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomly selected |
Allocation concealment (selection bias) | Unclear risk | Unclear |
Blinding (performance bias and detection bias) All outcomes | Low risk | Fitted sleeve over injection barrel to decrease recognition independent person prepared injections in identical syringes |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | May have been 1 dropout , shortest follow‐up time was 6 months not clear how many had final assessment at 30 months |
Selective reporting (reporting bias) | Unclear risk | Table 3 provides outcome on all patients but no time frame |
Other bias | Unclear risk | No power calculation, no details as to what classified as good outcome. No mention of whether pain relief gained was total or only for the treated branch |