Influence of Opioid Use on the Effects of Spinal Manipulative Therapy for Low Back Pain

This supplement expands the parent research project to include three additional Aims and the
recruitment of the 70 additional participants. The additional participants will undergo the
same assessment and intervention procedures outlined in the parent project to permit
leveraging the full cohort to evaluate the supplemental Aims.

The overall objective is to examine the impact of opioid use on patient-centered and
mechanistic outcomes related to SMT and explore the impact on SMT followed by various
co-interventions. The goal of this research is to better tailor SMT protocols to optimize
outcomes for patients with LBP who are opioid users and facilitate efforts to reduce reliance
on opioid pain management among those with LBP. Accomplishing this goal will facilitate
future research evaluating the efficacy of non-pharmacologic alternative pain management
strategies for individuals with LBP.

Specific Aims to be addressed through this supplement are:

1. Compare baseline psychological, mechanistic and LBP-related characteristics between
sub-groups of participants with LBP based on opioid use.

2. Examine the association of opioid use with changes in mechanistic and patient-centered
outcomes between a baseline assessment and subsequent assessment after 1-week and
completion of a 2-session SMT intervention protocol.

3. Explore the moderating effects of opioid use on mechanistic and patient-centered
outcomes obtained 4 weeks following SMT intervention with varied co-intervention
components.

Examining these aims as a supplement to the parent project will allow evaluation of whether
or not opioid use impacts short-term mechanistic and patient-centered outcomes of SMT (Aim
2), and will explore if the longer-term effects of the three co-interventions differ between
opioid users and non-users. (Aim 3). This research will also compare baseline characteristics
between participants who are or are not opioid users (Aim 1).

Inclusion Criteria:

- Pain between the 12th rib and buttocks with or without symptoms into one or both legs,
which, in the opinion of the examiner, originate from the lumbar region.

- Age 18 - 60 years

- Oswestry disability score > 20%

- Self-reported

Exclusion Criteria:

- Prior surgery to the lumbosacral spine

- Currently pregnant

- Currently receiving mind-body or exercise treatment for LBP from a healthcare provider
(e.g., chiropractic, physical therapy, massage therapy, etc.)

- Neurogenic signs including any of the following: positive ipsi- or contra-lateral
straight leg raise test; reflex, sensory, or strength deficit in a pattern consistent
with lumbar nerve root compression