A Randomized Pragmatic Clinical Trial of Chiropractic Care for Headaches With and Without a Self-Acupressure Pillow.

OBJECTIVE: The purpose of this study was to determine if the addition of a self-acupressure pillow (SAP) to typical chiropractic treatment results in significantly greater improvement in tension-type and cervicogenic headache sufferers. METHODS: A pragmatic randomized clinical trial was conducted in a chiropractic college teaching clinic. Thirty-four subjects, including tension-type and cervicogenic headache sufferers, 21 to 60 years of age, male or female, completed the study. Group A (n = 15) received typical chiropractic care only (manual therapy and exercises), and group B (n = 19) received typical chiropractic care with daily home use of the SAP. The intervention period was 4 weeks. The main outcome measure was headache frequency. Satisfaction and relief scores were obtained from subjects in the SAP group. Analysis of variance was used to analyze the intergroup comparisons. RESULTS: Owing to failure of randomization to produce group equivalence on weekly headache frequency, analysis of covariance was performed showing a trend (P = .07) favoring the chiropractic-only group; however, this was not statistically significant. Group A obtained a 46% reduction of weekly headache frequency (t = 3.1, P = .002; d = 1.22). The number of subjects in group A achieving a reduction in headaches greater than 40% was 71%, while for group B, this was 28%. The mean benefit score (0-3) in group B of the use of the SAP was 1.2 (.86). The mean satisfaction rating of users of the SAP was 10.4 (2.7) out of 15 (63%). CONCLUSION: This study suggests that chiropractic care may reduce frequency of headaches in patients with chronic tension-type and cervicogenic headache. The use of a self-acupressure pillow (Dr Zaxx device) may help those with headache and headache pain relief as well as producing moderately high satisfaction with use.

Retention of blinding at follow-up in a randomized clinical study using a sham-control cervical manipulation procedure for neck pain: secondary analyses from a randomized clinical study.

OBJECTIVE: Participants in clinical trials of spinal manipulation have not been rigorously blinded to group assignment. This study reports on secondary analyses of the retention of participant blinding beyond the immediate posttreatment time frame following a single-session, randomized clinical study. A novel control cervical manipulation procedure that has previously been shown to be therapeutically inert was contrasted with a typical manipulation procedure. METHODS: A randomized clinical study of a single session of typical vs sham-control manipulation in patients with chronic neck pain was conducted. Findings of self-reported group registration at 24 to 48 hours posttreatment were computed. The Blinding Index (BI) of Bang et al was then applied to both the immediate and post-24- to 48-hour results. RESULTS: Twenty-four to 48 hours after treatment, 94% and 22% of participants in the typical and control groups, respectively, correctly identified their group assignment. When analyzed with the BI of Bang et al, the immediate posttreatment BI for the group receiving a typical manipulation was 0.22 (95% confidence interval [CI], -0.03 to 0.47); for the group receiving a control manipulation, it was 0.19 (95% CI, -0.06 to 0.43). The BI at post-24 hours was as follows: typical = 0.75 (95% CI, 0.59-0.91) and control = -0.34 (95% CI, -0.58 to -0.11). CONCLUSIONS: This study found that the novel sham-control cervical manipulation procedure may be effective in blinding sham group allocation up to 48 hours posttreatment. It appears that, at 48 hours posttreatment, the modified form of the typical cervical manipulation was not. The sham-control procedure appears to be a promising procedure for future clinical trials.

Staging the use of teaching aids in the development of manipulation skill.

Skill development in manual therapies is influenced by a number of factors. The effects of the training program organization, mentor coaching, feedback in various forms, and electromechanical training aids are factors that have been studied. A significant gap exists in understanding when teaching aids might be most effective within a defined curriculum structure. This project used the ratio of instructional theory and laboratory practice to define the learning context. An electromechanical training aid (Dynadjust™) was introduced at different stages (year 2 and year 4) of training for high-velocity, low-amplitude (HVLA) manipulation. Learners were assigned to either the Aid group or the NoAid group. Independent assessment of skill was evaluated before and after 6 weeks by means of recording force-time profiles of HVLA performance. Repeated measures analysis of variance (ANOVA) evaluated change scores in the force amplitude and rate of rise in force. Program features were dominated by a low ratio of laboratory practice to didactic foundational education components. Use of the aid was not associated with any measurable gains for participants when used in year 2. Later participation in year 4 suggested enhanced development in rate of rise for force (p < 0.0597) and for peak force (p < 0.0303). Careful attention should be given to the sequencing of content and laboratory work in designing curricula for training programs. For programs using lower ratios of laboratory contact hours, teaching aids to augment practice may result in better performance gains when introduced later than if added early in the curriculum.

Validation of a novel sham cervical manipulation procedure.

BACKGROUND CONTEXT: No clinical trial of spinal manipulation for chronic neck pain (NP), for either single or multiple intervention session(s), has used an effective manual sham-manipulation control group. PURPOSE: Validate a practical sham cervical high-velocity low-amplitude spinal manipulation. STUDY DESIGN/SETTING: Randomized experimental validation study in an institutional clinical research laboratory. PATIENT SAMPLE: Eligible subjects were males and females, 18 to 60 years of age with mechanical NP (as defined by the International Association for the Study of Pain Classification) of at least 3 months' duration. Subjects with arm pain, any pathologic cause of NP, or any contraindication to spinal manipulation were excluded. OUTCOME MEASURES: The primary outcome was the patient's self-report or registration of group allocation after treatment. Secondary outcomes were numerical rating scale-101 for NP, range of motion (ROM; by goniometer), and tenderness (by pressure algometry). METHODS: Eligible subjects were randomly allocated to one of two groups: real cervical manipulation (RM) or sham cervical manipulation (SM). All subjects were given two procedures in sequence, either RM+SM or SM+SM. Immediately after the two procedures, subjects were asked to register any pain experienced during the procedures and to identify their treatment group allocation. Force-time profiles were recorded during all procedures. Secondary clinical outcome measures were obtained at baseline, 5 and 15 minutes after the intervention, including ROM, self-report of pain, and local spinous process tenderness. Data for each variable were summarized and tested for normality in distribution. Summary statistics were obtained for each variable and statistically tested. RESULTS: Sixty-seven subjects were randomized. Data from 64 subjects (32 per group) were available for analysis. There were no significant differences between the groups at baseline. One adverse event occurred in the "real" group, which was a mild posttreatment pain reaction lasting less than 24 hours. In the RM group, 50% of subjects incorrectly registered their treatment allocation; in the sham group, 53% did so. For the SM group, none of the procedures resulted in cavitation, whereas in the RM group, 87% of procedures resulted in cavitation. There were no significant changes between groups on pain, tenderness, or ROM. Force-time profiles of the RM and SM procedures demonstrated fidelity with significant differences between components as intended. CONCLUSIONS: The novel sham procedure has been shown to be effective in masking subjects to group allocation and to be clinically inert with respect to common outcomes in the immediate posttreatment stage. Further research on serial applications and for multiple operators is warranted.