To determine if asymptomatic adults will experience the adverse effects of headache and neck pain following one week of test-pillow usage.
The study design is that of a Before-After trial.
The subjects were 23 healthy adults with asymptomatic cervical spines, with a mean (sd) age of 26.4(4.4) years, without any known organic pathology within or referring from the cervical spine.
Outcome Measures and Statistical Analysis:
The outcome measures of pain severity, sleep quality and pillow comfort were used via a daily diary-type of questionnaire. The diary-questionnaire was judged to demonstrate acceptable sensibility. Pre- and post-trial pain states, as well as ratings of comfort were analyzed using the paired t-test at the (Bonferroni-corrected) 0.025 level of significance.
Because none of the 4 paired t-tests yielded clinically important or statistically significant differences between pre vs. post measures, this trial suggests that the majority (91%) of asymptomatic subjects did not become symptomatic after one week of using this pillow.
This study suggests that asymptomatic young adults will not experience the adverse effects of headache and neck pain following one week of using this newly designed semi-customized cervical pillow. It is therefore concluded that this pillow is ethically safe to further test on a demographically similar symptomatic population.
Perhaps the most important message to be taken away from this paper is that all care givers should actively look for adverse effects information on all forms of treatment relevant to their practice. It is not enough to know that one intervention is better than another by an average of “x” units (of some outcome measure); the astute consumer of the research literature will also look for:
a) the proportion of subjects reaching some clinically important positive endpoint:
b) the proportion of subjects reaching some clinically important negative (adverse) endpoint; and
c) the proportion of subjects experiencing NO clinically important endpoint.
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