Sham manual medicine protocol for cervical strain-counterstrain research.

OBJECTIVE: To describe the development of a sham manual medicine protocol. SETTING: An academic physical medicine and rehabilitation clinic. PARTICIPANTS: Twenty-six persons with cervical tender points were included in the pilot study. Exclusion criteria entailed cervical disk herniations or diskitis, cancer, current incarceration, or any condition that prevented small-range passive neck movements. Subjects were also excluded if, in the past 3 months, they had received cervical or thoracic spine surgery, osteopathic manipulation, or workers' compensation benefits. INTERVENTIONS: The subjects were sequentially assigned to receive either sham or strain-counterstrain treatment. The subjects filled out pre- and posttreatment questionnaires. Fifteen subjects were in the sham group, and 11 were in the treatment group. MAIN OUTCOME MEASURES: Outcome measures included subject tolerance of manual medicine, change in pain level, and ability to accurately determine receipt of strain-counterstrain or sham technique. Statistical significance was set at P < .05. RESULTS: There were no adverse effects of the sham or treatment protocols. There was no statistically significant change in pain as a result of the sham manual medicine protocol (P = .222) in contrast to the strain-counterstrain group, which did have decreased pain (P = .014). The subjects were unable to determine whether they had received sham or strain-counterstrain technique (P = .850). CONCLUSION: The sham protocol developed for this study was well tolerated. The small study size and design limitations do not yet allow the sham protocol developed in this pilot study to be definitively validated as a manual medicine tool, but there are early indications that it may be useful. Larger studies that validate this sham protocol by addressing inter- and intra-rater reliability are needed, followed by studies that evaluate strain-counterstrain as a treatment modality.