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All outcome measures will be recorded at all three measurements.
An average of the measures will be recorded (where there are three measurements taken, the two closest will be averaged; where the three measures are equidistant the median value will be used).
Process measures and cost measures will be recorded.
Trial outcome measures will be recorded as indicated in table 1.
Outcome measures will be recorded by an assessor blinded to group allocation.
Outcome measures will be recorded by a researcher who is blinded to subject allocation.
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The primary outcome measure will be recorded 6 weeks after the expected due date.
The primary outcome measure will be recorded 10 weeks after the expected term date.
Study characteristics such as the study population, country in which the study was conducted, year of publication, language of publication, journal, age range, study design, criteria for sample selection and sample size, diagnostic criteria and outcomes measured, will be recorded.
The following valid and reliable measures of pain will be recorded: Pain Intensity Numerical Rating Scale (Pain NRS) will measure participant's average pain intensity over the previous 7 days.
The following baseline measures of outcome will be recorded: Numerical pain rating scale on a 0 10 scale [ 14]; A back specific disability scale (Roland Morris Disability Scale) [ 15]; A patient specific measure of disability (Patient Specific Functional Scale)[ 16]; Immediately after completing baseline measures participants will be allocated into treatment groups.
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