A Preliminary Path Analysis of Expectancy and Patient-Provider Encounter in an Open-Label Randomized Controlled Trial of Spinal Manipulation for Cervicogenic Headache

Abstract 

Objective

The purpose of this article was to present a preliminary model to identify the effects of expectancy of treatment success and the patient-provider encounter (PPE) on outcomes in an open-label randomized trial.

Methods

Eighty participants with chronic cervicogenic headache (CGH) were randomized to 4 groups: 2 levels of treatment dose (8 or 16) and 2 levels of therapy from a chiropractor (spinal manipulation or light massage). Providers were instructed to have equal enthusiasm for all care. Structural equation modeling with standardized path coefficients (β) was used in a path analysis to identify the effects of patient expectancy and the PPE on CGH pain. The model included monthly pain from baseline to 12 weeks. Expectancy and PPE were evaluated on Likert scales. The patient-provider encounter was measured as patient perception of chiropractor enthusiasm, confidence, and comfort with care.

Results

Baseline patient expectancy was balanced across groups. The PPE measures were balanced across groups and consistent over the 8-week treatment period. Treatment and baseline pain had the strongest effects on pain outcomes (|β| = .46-.59). Expectations had little effect on pain (|β| < .15). The patient-provider encounter had a weak effect on pain (|β| = .03-.27) and on subsequent confidence in treatment success (|β| = .09 and .12).

Conclusions

Encouraging equipoise in the PPE and balancing expectancy across treatment groups may protect against some confounding related to the absence of blinding in a randomized controlled trial of pain. In this trial, their effects were found to be small relative to the effects of treatment and baseline values.

Key Indexing Terms: Statistical Model, Cervicogenic Headache, Spinal Manipulation, Chiropractic, Randomized Controlled Trial