As a needed first step prior to a planned full-scale RCT, in order to assess the feasibility
of the RCT and refine its design and protocols, we will perform a pilot study with the
following objectives:1.To assess whether enough veterans with chronic LBP can be identified,
meet eligibility criteria and be randomized to demonstrate that recruitment for a planned
full-scale RCT is feasible. 2.To assess whether veterans with chronic LBP will adhere to
protocol interventions per study protocol. 3.To assess whether veterans with chronic LBP
will complete data collection per study protocol. 4.To obtain estimates of effect sizes and
the corresponding standard errors of the primary efficacy outcome measures to estimate the
required sample size of a planned full-scale RCT.
Chronic low back pain (LBP) is associated with poor health, lower quality of life, high
costs, and is highly prevalent in veterans. Both chiropractic care and exercise have
modestly reduced pain and/or improved function in randomized controlled trials (RCTs) of
patients with chronic LBP. However, effects may not apply similarly to all populations. For
example, there are no RCT data on chiropractic care for older (age >70) patients with
chronic LBP, though with increased spinal arthritis, comorbidities and frailty, such
patients may require modified chiropractic techniques and likely differ in response to
chiropractic treatment. While a recent systematic review of RCTs predicted that a home
exercise program that was individualized, high-dose, therapist-directed, and incorporated
stretching and strengthening would be a meaningful treatment for chronic LBP, it also could
provide a robust comparison group for other chronic LBP treatments. The combination of such
a regimen and chiropractic care is predicted to have additive benefits for chronic LBP but
this premise hasn't been directly tested. To further our aim of improving the health of
chronic LBP patients, we plan an RCT in veterans with chronic LBP, to compare the
effectiveness, cost-effectiveness and cost-utility of a tailored education/exercise (E/E)
intervention alone vs. E/E plus chiropractic care. The demographics and medical complexity
of the veteran population provide a great opportunity to test the appropriate role of
chiropractic care for such patients with chronic LBP and to advance chronic LBP research and
Subjects will be recruited primarily from patients attending Minneapolis VAMC clinics with
complaints of chronic LBP. Thirty eligible veterans will be randomized to E/E alone vs. E/E
plus chiropractic care. All participants will receive E/E instruction in four 1-hr
individual sessions over 8 weeks, including an individually designed, high dose,
therapist-directed home exercise program. Chiropractic care will be delivered by
chiropractors and follow standard protocols, with up to 12 sessions over 12 weeks.
Participants randomized to E/E alone will attend 10 weekly exam/interview sessions so that
their contact with providers is comparable to that received by participants who also receive
chiropractic care. The recruitment goal is to generate the potential to randomize 6-10
participants/month. Recruitment feasibility will be assessed by tracking the number of
patients who make initial inquiries, undergo screening and in-clinic evaluation, and are
randomized. Further, reasons for nonparticipation and disqualification will be examined and
described. Participant adherence to interventions will be defined as completing >3 of 4
education sessions, >20 hrs of home exercise, and >80% of recommended chiropractic visits or
nonchiropractic follow-up exam/interviews. Adherence with clinic visits will be assessed
with provider treatment logs. Home exercise compliance will be tracked by questionnaire.
Participant adherence to data collection will be defined as >90% follow-up rates at each
time point and assessed by tracking questionnaire completion rates. Descriptive data for
the distributions of the primary and main secondary efficacy outcome measures will be used
to calculate sample size and generate power tables for the full-scale trial.
- Veterans enrolled to receive VA medical care
- Current low back pain episode present > 6 weeks.
- LBP pain score > 3 on scale of 0-10.
- LBP classified using the Quebec Task Force (QTF) system as types 1-4 respectively,
patients with LBP, stiffness or tenderness, without radiation; with radiation
proximal to knee; with radiation distal to knee; or with radiation and >2 abnormal
neurological exam findings.
- No change in past month in prescription medications affecting musculoskeletal pain.
- Low back pain classified as QTF type 5-11
- Progressive neurologic deficits due to nerve root or spinal cord compression,
including symptoms/signs of cauda equina syndrome.
- Previous lumbar spine surgery, by history and/or screening spine radiograph.
- Acute vertebral fracture, by history and spine radiograph
- Self-reported ongoing LBP treatment by other healthcare providers other than stable
prescription medications affecting musculoskeletal pain.
- Infectious and noninfectious inflammatory destructive spine tissue changes, by spine
- Self-reported pending/current litigation pertaining to back pain, including workers
compensation claims; or pending evaluation of VA service connected rating related to
- Clinically significant chronic inflammatory spinal arthritis
- Self-reported pregnancy
- Self-reported current substance abuse
- History of bleeding disorder
- Known arterial aneurysm near LBP area
- Possible/confirmed spinal/vertebral infection, by history and spine radiograph
- Primary or metastatic vertebral malignancy, by history and spine radiograph