Patients to Treatment Randomized? Explain.

¶ … patients to treatment randomized? Explain.

Yes, a triple-blind, RCT was used for examining the immediate effects of the cervical spine mobilization techniques on neck pain and active cervical ROM. The patients were randomly assigned into either preferred or random mobilization group by using a concealed envelope.

Were all patients who entered the trial properly accounted for at its conclusion? What percentages of subjects were accounted for at the conclusion of the study?

Yes, all patients who entered the trial were properly accounted for at its conclusion. There were 84 that were assessed for eligibility. 24 of the patients were excluded for not meeting the inclusion criteria. That left 60 patients to be randomized into the two groups. There were 30 put into each group. This means that 100% of the subjects were accounted for at the conclusion of the study.

Were patients, their clinicians, and study personnel 'blind' to treatment? How was this accomplished? If it was not done, how could it have been done? What were the obstacles to having a 'blind treatment' study?

The patients were randomly assigned into either preferred or random mobilization group by using a concealed envelope. The first therapist who was blind to the group performed the screening, assessing, prescribing the spinal levels, and the grade of mobilization. The second therapist who was blind to the group performed the mobilization treatment according to their allocated group stated in an envelope. The assessor who was also blind to the group allocation conducted the measurements of pain and active cervical ROM.

One limitation that was noted in performing this blind treatment study was that almost all the patients that were treated had chronic or sub-acute or chronic neck pain. It was felt that different results would have been seen if more of the subjects would have had acute neck pain.

4. Were the groups similar at the start of the trial? (demographics, co-morbidity, severity of pathology). Please describe these conditions. If different, were these adjusted for?

Subjects for this study consisted of patients suffering from mechanical neck pain that was unilaterally distributed for at least 1-week duration. They were included in the study if their symptoms were primarily confined in the area between the superior nuchal line and the tip of the first thoracic spinous process and were provoked by neck movements or by sustained neck postures.

5. Aside from the experimental intervention, were the groups treated equally? (co-intervention, compliance) What was the intervention? What was the difference between the groups?

Aside from the experimental intervention all the groups were treated equally. The intervention consisted of the preferred mobilization group receiving the unilateral PA pressure on the side of the symptoms (ipsilateral). The random mobilization group received 1 of the following 3 mobilization techniques that could be applied in the clinic as a placebo intervention: the central PA, ipsilateral unilateral PA, or contralateral unilateral PA pressure.

6. Overall, are the results of the study valid? Why or why not?

Overall the results of this study were valid because the researchers created a hypothesis that they then tested with a research design that measured whether patients suffering from unilateral mechanical neck pain preferred mobilization or the ipsilateral unilateral PA mobilization technique.

7. Was the treatment effect significant enough to consider using this intervention in practice?

The results of the current study suggest that, in patients suffering from unilateral mechanical neck pain, the preferred mobilization or the ipsilateral unilateral PA mobilization is no more effective than the random mobilization.

8. Were the treatment benefits significant and efficient enough to be worth the cost of treatment? Do you think an insurance company, Medicare, or Medicaid would reimburse for this treatment? Explain