Table A2:
GRADE Evidence Profile for Comparison of 10-kHz High-Frequency SCS Versus Conventional SCS for Chronic Noncancer Pain—Randomized Controlled Trials
| Number of Studies (Design) | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Upgrade Considerations | Quality |
|---|---|---|---|---|---|---|---|
| Pain Intensity | |||||||
| 3 (RCTs)28–30 | Serious limitations (−1)a | No serious limitations | No serious limitations | No serious limitations | Undetected | NA | ⊕ ⊕ ⊕ Moderate |
| Functional Disability | |||||||
| 3 (RCTs)28–30 | Serious limitations (−1)a | No serious limitations | No serious limitations | No serious limitations | Undetected | NA | ⊕ ⊕ ⊕ Moderate |
| Opioid Use | |||||||
| 1 (RCT)28 | Serious limitations (−1)a | No serious limitations | No serious limitations | Serious limitations (−1)b | Undetected | NA | ⊕ ⊕ Low |
| Patient Satisfaction | |||||||
| 2 (RCTs)28,30 | Serious limitations (−1)a | No serious limitations | No serious limitations | No serious limitations | Undetected | NA | ⊕ ⊕ ⊕ Moderate |
| Global Impression of Change | |||||||
| 3 (RCTs)28–30 | Serious limitations (−1)a | No serious limitations | No serious limitations | No serious limitations | Undetected | NA | ⊕ ⊕ ⊕ Moderate |
| Sleep Quality | |||||||
| 2 (RCTs)28,30 | Serious limitations (−1)a | No serious limitations | No serious limitations | No serious limitations | Undetected | NA | ⊕ ⊕ ⊕ Moderate |
| Health-Related Quality of Life | |||||||
| 3 (RCTs)28–30 | Serious limitations (−1)a | Serious limitations | No serious limitations | No serious limitations | Undetected | NA | ⊕ ⊕ ⊕ Moderate |
Abbreviations: GRADE, Grading of Recommendations Assessment, Development, and Evaluation; RCT, randomized controlled trial; SCS, spinal cord stimulation.
a
Blinding of patients and investigators was not done.
b
Only one trial reported on opioid use, and doses were extremely variable.