| PMC full text: | Published online 2014 Jul 23. doi: 10.1186/s12998-014-0026-7
|
Table 1
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Short Term Treatment Versus Long Term Management of Neck and Back
Disability in Older Adults Utilizing Spinal Manipulative Therapy and Supervised Exercise
Differences between the initial and modified trial designs and precipitating reasons for the change
| Initial design | Modified design | Rationale |
|---|---|---|
| Three-arm trial (n = 300) | two-arm trial (n = 200) | Enrollment |
| • 36 weeks SMT + SRE (n = 88) | • 36 weeks SMT + SRE (n = 100) | Funding |
| • 12 weeks SMT + SRE (n = 124) | • 12 weeks SMT + SRE (n = 100) | |
| • 36 weeks SRE alone (n = 88) | | |
| n = 300 | n = 200 (for primary and secondary aims 1–4) | Enrollment |
| n = 18 (for additional secondary aims A-C) | Funding | |
| Randomization ratio 1:1.4:1 | Final randomization ratio 1:1 | Enrollment |
| Funding | ||
| Pertinent inclusion/exclusion criteria: | Pertinent inclusion/exclusion criteria: | Enrollment |
| • NDI and ODI ≥ 15% each at both baseline evaluations | • NDI and ODI ≥ 10% each AND combined score of ≥ 25% at first baseline evaluation only | |
| Functional outcomes: | Functional outcomes: | Funding |
| • short physical performance battery | ||
| • hand grip strength | ||
| • accelerometry | • short physical performance battery | |
| • postural sway | • hand grip strength | |
| • range of motion | • accelerometry | |
| • static endurance |