Ercelen 2003.
Methods | RTC | |
Participants | VKV American Hospital, Pain Management Department, Istanbul, Turkey (N = 39) Inclusion criteria
Exclusion criteria
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Interventions |
Group A was treated with a 120‐second 80°C lesion of the intervertebral disc after injection of a mixture of 1 to 2 mL of dye and local anaesthetic (N = 20) Group B was treated with a 360‐second 80°C lesion of the intervertebral disc after injection of a mixture of 1 to 2 mL of dye and local anaesthetic (N = 19) |
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Outcomes | No significant changes between groups in pain and function
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Notes | Dropouts: 2 (5%) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants randomly assigned to 2 treatment groups by computer |
Allocation concealment (selection bias) | Unclear risk | Remained unclear from text |
Blinding (performance bias and detection bias) All outcomes ‐ patients? | High risk | Participants not blinded |
Blinding (performance bias and detection bias) All outcomes ‐ providers? | High risk | Providers not blinded |
Blinding (performance bias and detection bias) All outcomes ‐ outcome assessors? | High risk | Participants not blinded and all outcomes participant reported |
Incomplete outcome data (attrition bias) All outcomes ‐ drop‐outs? | Low risk | Two participants (5%) dropped out |
Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis? | Low risk | Attrition bias unlikely because of design ? |
Selective reporting (reporting bias) | Unclear risk | No protocol available |
Baseline characteristics similar? | Low risk | Groups comparable on relevant demographic and clinical variables |
Co‐interventions avoided or similar? | Unclear risk | Remained unclear from text |
Compliance acceptable? | Low risk | Irrelevant: single‐session intervention |
Timing of outcome assessments similar? | Low risk | Outcomes measured directly after procedure and at 1 week, 2 weeks, 1 month, 2 months, 3 months and 6 months after procedure |