200172 Baseline physical exam predicts final self-reported pain outcomes from a randomized trial on chronic cervicogenic headache

Monday, November 9, 2009: 11:30 AM

Darcy Vavrek, ND, MS , Center for Outcomes Studies, Western States Chiropractic College, Portland, OR
Mitchell Haas, DC , Center for Outcomes Studies, Western States Chiropractic College, Portland, OR
David Peterson, DC , Center for Outcomes Studies, Western States Chiropractic College, Portland, OR
Purpose: The goal of this analysis is to find which baseline physical exam (PE) measures best predict clinically relevant self-reported outcomes at 24 weeks.

Methods: This is an exploratory analysis of data generated by baseline PE from an open-label randomized controlled study. 80 subjects were randomized to 8 or 16 treatments of spinal manipulative therapy or light massage control over 8 weeks. Self-reported outcomes of interest included headache and neck pain and disability, and number of headaches and related disability days in the last four weeks. PE included motion palpation of the cervical and upper thoracic regions, inclinometric evaluation of active cervical range of motion (ROM) and associated pain, and algometric pain threshold (PPT) over articular pillars. The association between PE variables and outcomes were evaluated using forwards then backwards stepwise generalized linear models, adjusting for baseline outcome and treatment group. The resulting prediction models identify independent PE predictors of self-reported outcomes.

Results: Restricted cervical lateral bending ROM (p=.010) was predictive of lower week 24 neck disability. Pain on flexion (p=.004) and cervical flexion ROM (p=.002) were independently predictive of number of headaches at 24 weeks. Other predictors of week 24 self-reported outcomes include pain on extension, cervical extension ROM, and pain pressure threshold.

Conclusions: We noted a number of baseline PE findings that predict measures of 24 week headache and neck pain and disability. This is an important step towards establishing and understanding objective measures of outcomes for clinical studies.

Funded by NCCAM/NIH (R21AT002324)

Learning Objectives:
1. Describe RCT design and primary self-reported outcomes. 2. Name elements of baseline physical exam. 3. Explain forwards stepwise regression. 4. Identify baseline physical exam variables that are predictive of week 24 self-reported outcomes (forwards stepwise regression) after adjusting for treatment group and baseline self-reported outcome. 5. Explain backwards stepwise regression and differentiate from forwards stepwise regression. 6. Discuss which baseline physical exam variables remain predictive of week 24 self-reported outcomes (backwards stepwise regression) after being placed in the same model, dropping if p-value is greater than a chosen cut-off, and adjusting for treatment group and baseline self-reported outcome. 7. Compare resulting models to clinical expertise, to see if this matches what is expected, and how this informs future research.

Keywords: Chiropractic, Clinical Trials

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am the person who did the statistical analysis and will be the primary author on the paper when it is submitted for publication.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.