Cohen 2008.
Methods | RCT | |
Participants | Johns Hopkins Medical Institutions, Maryland & Walter Reed Army Medical Center, Washington, DC, USA (N = 28) Inclusion criteria
Exclusion criteria
|
|
Interventions |
Experiment group
Control group
|
|
Outcomes | Significant changes between groups for pain intensity (VAS) 1 and 3 months after treatment, and for function (ODI) 1 month after treatment
|
|
Notes | Dropouts: none | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random assignment in blocks of 4 via pre sealed envelopes |
Allocation concealment (selection bias) | Low risk | Presealed envelopes |
Blinding (performance bias and detection bias) All outcomes ‐ patients? | High risk | Blinding evaluated shortly after conclusion of the procedure, when effects of local anaesthetic were still active |
Blinding (performance bias and detection bias) All outcomes ‐ providers? | High risk | Participants treated with placebo after 1 month |
Blinding (performance bias and detection bias) All outcomes ‐ outcome assessors? | High risk | Participant‐reported outcome measures. Participants who did not show adequate symptomatic improvement were unblinded at follow‐up. For those who reported significant relief 1 month after the procedure, unblinding was done 3 months after treatment |
Incomplete outcome data (attrition bias) All outcomes ‐ drop‐outs? | Low risk | No dropouts; only 3 placebo participants refused to cross over |
Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis? | High risk | Cross‐over procedure |
Selective reporting (reporting bias) | Unclear risk | No protocol available |
Baseline characteristics similar? | High risk | Meaningful differences in morphine use and function |
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 | Similar until 3‐month follow‐up |