Haller H, Ostermann T, Lauche R, Cramer H, Dobos G. Credibility of a comparative sham control intervention for craniosacral therapy in patients with chronic neck pain [published online October 6, 2014]. Complement Ther Med. 2014;22(6):1053-1059. doi:10.1016/j.ctim.2014.09.007.
German integrative medicine researchers at the University of Duisburg-Essen assessed the applicability of a sham-controlled intervention of craniosacral therapy (CST) in the treatment of patients with chronic neck pain. The data reported were secondary findings of a randomized controlled trial on neck treatment (the primary outcome measures have not yet been reported). Fifty-four patients were randomly assigned to either a CST group or a sham-CST group. The CST protocol included cranial manual techniques well known to osteopathic physicians who use osteopathic cranial manipulative medicine (OCMM). The sham-CST was light touch "without therapeutic intention" for the same amounts of time and applied to the same regions of the body as the CST.
Each patient was seen at 8 weekly 45-minute sessions. The patients all had chronic neck pain lasting at least 3 months with moderate intensity of at least 45 on a 100-mm visual analog scale. Four different therapists provided the interventions.
Outcome measures were the Credibility/Expectancy Questionnaire and the Helping Alliance Questionnaire obtained at the end of the eighth session. The results for adjusted ORs showed no difference between groups for the following Credibility/Expectancy Questionnaire items: (1) How confident are you that CST will be successful in reducing your neck pain symptoms? (2) How logical does CST seem to you for treating your limitations due to neck pain? and (3) How confident would you be in recommending CST to a friend with the same problem? Likewise, there was no difference between groups for the Helping Alliance Questionnaire variables of relation to therapist and satisfaction with treatment. Per-protocol analysis by regression coefficient revealed a significant difference between the groups for satisfaction with treatment, but findings were not significant in the intent-to-treat analysis.
Previous osteopathic research using "light touch" found light touch to have a treatment effect.
1 As a treatment provider in that study, I can say that had there been a more concerted effort to mentally avoid "therapeutic intent," results might have been different. However, in a study
2 that showed the effects of OCMM on cerebral tissue oxygenation, light touch without therapeutic intent (not reported in the study) was used effectively (Scott T. Stoll, DO, verbal communication, January 2012).
I believe light touch sham OCMM is valid and this study presents a way to use such procedures in osteopathic research. (doi:10.7556/jaoa.2015.008)
University of California, San Diego School of Medicine