Table 5.
Exclusion decisions rendered during case review for Trial 1
| Exclusion criterion | Exclusion reasons for participants (n =122) who met a single exclusion criterion | Exclusion reasons for participants (n =63) who met multiple exclusion criteria | Number of participants meeting each exclusion criterion alone or combined with another |
|---|---|---|---|
| Other exclusions* | 81 | 27 | 108 |
| Safety risk^ | 17 | 14 | 26 |
| Quebec Task Force for Spinal Disorders classification# | 13 | 9 | 22 |
| General poor health | 4 | 10 | 14 |
| Alcohol or drug use | 3 | 3 | 6 |
| Osteoporosis | 1 | 2 | 3 |
| Uncontrolled hypertension | 2 | 0 | 2 |
| Vascular claudication | 1 | 1 | 2 |
| Bleeding disorder | 0 | 1 | 1 |
| Prior spinal surgery | 0 | 1 | 1 |
*Other exclusions included compliance concerns, referral needed, peripheral neuropathy, neuromuscular disease, or participant unable to tolerate study procedures.
^Safety risks related to treatment or testing procedures such as inflammatory spondyloarthropathy.
#Quebec Task Force for Spinal Disorders classifications 4 to 6 and 8 to 11 were exclusionary in this trial.