Rocha 2014.
| Study characteristics | ||
| Methods | Parallel RCT | |
| Participants | N = 36 Mean age (SD): Group 1: 42 years (13.5) Group 2: 44.4 years (8.9) Sex: 19 female, 17 male Upper limb CRPS Diagnostic criteria: IASP (Merskey 1994) then switched to IASP (Harden 2010). Participants screened under old criteria were then excluded. Duration of symptoms (months): Group 1: 22.7 (26.3) Group 2: 21.0 (2.16) Type of initiating injury: mixed: fractures, contusions, surgery, work‐related Concomitant treatments: unclear Previous treatment: 4 week standardised multimodal protocol including physical therapy, oral analgesic polytherapy: antidepressants, analgesics, opioids, gabapentin and psychological input. Medico‐legal factors: not reported |
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| Interventions | Group 1: LASB T2 sympathetic ganglion (fluoroscopically guided) Group 2: subcutaneous space injection of same agents (fluoroscopy also used) Agents: 10 ml anaesthetic + steroid. 5 ml 75% ropivacaine, 5 ml triamcinolone Evaluation of technical adequacy of block: yes ‐ measurement of arm temperature Number of blocks: 1 |
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| Outcomes | Average pain score from Brief Pain Inventory McGill Pain Questionnaire Adverse events 1 month and 1 year follow‐up |
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| Country of origin | Brazil | |
| Study aim | To evaluate the efficacy of TSB for upper limb CRPS‐I | |
| Notes | Authors declare no conflict of interest | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: no details reported |
| Allocation concealment (selection bias) | Low risk | Comment: participants asked to pick an unmarked opaque envelope containing allocation |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Personnel not blinded however, comparison is between two active invasive interventions |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: assessor blinded to intervention |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: 21% attrition at long‐term follow‐up and imbalanced across groups. No details provided regarding reasons for loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | Comment: outcomes reporting adequate |
| Adequate sample size? | High risk | Comment: N = 36 |
| Adequate duration of follow‐up? | Low risk | Comment: 1‐year follow‐up |
| Free of other bias? | High risk | Comment: average pain scores at baseline differ by more than 1 point |