A preliminary path analysis of expectancy and patient-provider encounter in an open-label randomized controlled trial of spinal manipulation for cervicogenic headache.
Study Goal
The researchers aimed to assess the effects of patient expectancy and the patient-provider encounter on pain outcomes in a trial comparing spinal manipulation and light massage for chronic cervicogenic headache.
Results Summary
The study found that treatment (spinal manipulation or light massage) and baseline pain had the strongest effects on pain outcomes, while patient expectancy and the patient-provider encounter had minimal effects.
Population
80 participants with chronic cervicogenic headache
Effective Dosage
8 or 16 sessions
Duration
8-week treatment period
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
spinal manipulation | decrease | pain outcomes | participants with chronic cervicogenic headache | |beta| = .46-.59 | had the strongest effects on | #1 |
light massage | decrease | pain outcomes | participants with chronic cervicogenic headache | |beta| = .46-.59 | had the strongest effects on | #2 |
treatment | decrease | pain outcomes | participants with chronic cervicogenic headache | |beta| = .46-.59 | had the strongest effects on | #3 |
baseline pain | neutral | pain outcomes | participants with chronic cervicogenic headache | |beta| = .46-.59 | had the strongest effects on | #4 |
expectations | no change | pain | participants with chronic cervicogenic headache | abs value(beta) < .15 | had little effect on | #5 |
patient-provider encounter | neutral | pain | participants with chronic cervicogenic headache | abs value(beta)= .03-.27 | had a weak effect on | #6 |
patient-provider encounter | neutral | subsequent confidence in treatment success | participants with chronic cervicogenic headache | abs value(beta)= .09 and .12 | had a weak effect on | #7 |
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 (beta) 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 (|beta| = .46-.59). Expectations had little effect on pain (abs value(beta) < .15). The patient-provider encounter had a weak effect on pain (abs value(beta)= .03-.27) and on subsequent confidence in treatment success (abs value(beta)= .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.