Table 6.
Exclusion decisions rendered during case review for Trial 2
| Exclusion criterion | Exclusion reasons for participants (n =22) who met a single exclusion criterion | Exclusion reasons for participants (n =11) who met multiple exclusion criteria | Number of participants meeting each exclusion criterion alone or combined with another |
|---|---|---|---|
| Evaluation or referral required* | 7 | 9 | 16 |
| Compliance^ | 7 | 5 | 12 |
| Aortic aneurysm | 2 | 1 | 3 |
| Alcohol or drug use | 2 | 1 | 3 |
| Treatment safety | 2 | 1 | 3 |
| Concurrent clinical management% | 1 | 2 | 3 |
| Memory impairment | 1 | 1 | 2 |
| Quebec Task Force for Spinal Disorders classification# | 0 | 1 | 1 |
| Cancer, active treatment | 0 | 1 | 1 |
*Evaluation or referral reasons such as recent medication changes with new onset of side effects, cardiovascular symptoms (e.g., unstable angina, new onset cardiac symptoms), progressive neurological signs/symptoms, depression or other mental health concern, etc.
^Compliance concerns such as transportation issues, family or work responsibilities, or reluctance for randomization to medical care group.
%Concurrent clinical management such as advanced renal disease or cardiovascular disease.
#Quebec Task Force for Spinal Disorders classifications 10 to 11 were exclusionary in this trial.