Table 4.
SCS placebo checklist—Items to include when reporting trials of SCS including a placebo arm
Item | Recommendation |
---|---|
Programming and management when the study includes patients with non‐rechargeable devices | Report programming parameters for the active and the sham arm |
Describe how the patient handheld programmer was managed | |
State how blinding was ensured if the patient handheld programmer was provided to the patients | |
For studies that utilize a subthreshold programming as a comparator: | |
Identify the position that the threshold was measured in | |
State if a feedback loop/position adjustment was utilized to vary current with position | |
Report the duration of daily use and frequency of programmer interactions | |
Programming and management when the study includes patients with rechargeable devices | Describe how a similar recharging burden was ensured in the different arms (i.e., report the frequency and duration of recharging) |
Report how the patient handheld programmer was managed (particularly if it contains a feedback screen that allows the subject to assess IPG charge) | |
Describe what provision was made for subjects to switch off their SCS in an emergency if patient handheld programmer was withheld | |
Research team | State if the team was split into blinded and unblinded side with no intermixing |
Report if there was one unblinded programmer member of the team | |
Clearly state which members of the research team were blinded | |
Effectiveness of blinding | Describe how effectiveness of blinding of patients and members of the research team was assessed |
Sham sensations | Describe how sham sensations were managed |
IPG, implantable pulse generator; SCS, spinal cord stimulation.