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Table 1 Differences between the initial and modified trial designs and precipitating reasons for the change

From: Short term treatment versus long term management of neck and back disability in older adults utilizing spinal manipulative therapy and supervised exercise: a parallel-group randomized clinical trial evaluating relative effectiveness and harms

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