1. Study population (30 points) |
a) Description of inclusion and exclusion criteria (1 point). Restriction to a homogeneous study population (1 point) |
b) Comparability of relevant baseline characteristics: duration of complaint (1 point), value of outcome measures (1 point), age (1 point), recurrences (1 point), and radiating complaints/associated symptoms (1 point) |
c) Description of the randomization procedure (2 points). Randomization procedure which excluded bias, i.e. random numbers table (2 points) |
d) Description of dropouts for each group and their reasons (3 points) |
e) Loss to follow-up: less than 20 % loss to follow-up (2 points), OR less than 10 % loss to follow-up (4 points) |
f) Sample size: greater than 50 subjects in the smallest group after randomization (6 points), OR greater than 100 subjects in the smallest group after randomization (12 points) |
2. Interventions (30 points) |
g) Correct description of the manual intervention (5 points). All interventions described (5 points) |
h) Pragmatic study: comparison with an existing treatment modality (5 points) |
i) Co-interventions avoided in the design of the study (5 points) |
j) Comparison with a placebo control group (5 points) |
k) Mention of the experience of the therapist (5 points) |
3. Measurement of effect (30 points) |
l) Placebo controlled studies: patients blinded (3 points), blinding evaluated and fully successful (2 points) OR Pragmatic studies: patients fully naive, evaluated and fully successful (3 points), time restriction of no manual treatments for at least 1 year (2 points) |
m) Outcome measures: pain assessment (2 points), global measure of improvement (2 points), functional status (2 points), spinal mobility (2 points), medical consumption (2 points) |
n) Each blinded outcome measure mentioned under item M earns 2 points |
o) Analysis of post-treatment data (3 points), inclusion of a follow-up period longer than 6 months (2 points) |
4. Data presentation and analysis (10 points) |
p) Intention-to-treat analysis when loss to follow-up is less than 10 % OR intention-to-treat analysis as well as worst-case analysis for missing values when loss to follow-up is greater than 10 % (5 points) |
q) Corrected presentation of the data: mean or median with a standard deviation or percentiles for continuous variables (5 points) |