22. The C.H.I.R.O. Study (Chiropractic Hospital-based Interventions Research Outcomes) Clinical...
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Transcript of 22. The C.H.I.R.O. Study (Chiropractic Hospital-based Interventions Research Outcomes) Clinical...
11SProceedings of the NASS 22nd Annual Meeting / The Spine Journal 7 (2007) 1S–163S
score at 8 weeks. The secondary outcomes showed that all gains in motor
score were sustained at 1 and 2 years. 100% of the patients had normal mo-
tor scores at the 2-year end point.
CONCLUSIONS: Patients with AS / HD and a motor score of O3/5 who
chose non-operative treatment did not develop a permanent or progressive
motor deficit.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2007.07.028
22. The C.H.I.R.O. Study (Chiropractic Hospital-based
Interventions Research Outcomes) Clinical Practice Guidelines For
Medical and Chiropractic Care of Acute Lower Back Pain: A
Randomized Controlled Trial
Paul Bishop, DC, MD, PhD1, Jeffrey Quon, DC, MHSC, FCCSC1,
David Olson, DC1, Don Nixdorf, DC1, Bradley Yee, DC, FCCS1,
Marcel Dvorak, MD, FRCS1, Charles Fisher, MD, MHSC, FRCS1;1University of British Columbia, Vancouver, British Columbia, Canada
BACKGROUND CONTEXT: Evidence-based clinical practice guide-
lines (CPG) for the management of patients with acute mechanical lower
back pain (ALBP) have been defined on an international scale. Multicenter
clinical trials have demonstrated that most ALBP patients do not receive
CPG-based treatment. To date, the value of implementing full and exclu-
sively CPG-based treatment remains unclear.
PURPOSE: To determine if full CPG-based care is more effective than
usual care (UC) in the treatment of ALBP.
STUDY DESIGN/SETTING: A two arm, parallel design, randomized
control trial.
PATIENT SAMPLE: Inclusion: Ages 19–59; QTFSD I and II ALBP !4
weeks. Exclusion: ‘‘Red flag’’ conditions, co-morbidities contraindicating
Chiropractic spinal manipulative therapy (CSMT).
OUTCOME MEASURES: Primary outcome: Difference in Roland Mor-
ris Disability (RDQ) scores at 16 weeks between the CPG and UC groups.
Secondary outcome: Differences in Bodily Pain (BP), Physical Function-
ing (PF) SF-36 domain scores at 16 weeks.
METHODS: Patients were assessed by a spine physician and randomized
to CPG care (re-assurance, avoidance of passive treatments; acetamino-
phen; four weeks of lumbar CSMT; return to work within eight weeks),
or family physician-directed UC, the components of which were recorded.
Hospital / University Ethics approval was obtained.
RESULTS: 88 patients were recruited with 39 in the CPG group and 38 in
the UC group completing the study. Descriptive analyses showed that base-
line prognostic variables were evenly distributed between groups. The pri-
mary outcome showed a mean difference in RDQ scores in the CPG group
(�2.52) that was statistically significantly greater than those in the UC
group (�0.25) (p!0.001). The secondary outcomes showed that both the
BP and PF domains of the SF-36 were statistically significantly improved
(p!0.05) in the CPG group when compared to the UC group.
CONCLUSIONS: This is the first randomized control trial demonstrating
that full CPG care, including CSMT, produces more favorable patient out-
comes than family physician-directed UC in patients with ALBP.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2007.07.029
23. Access to Spine Care and the Associated Burdens for Poor and
Near-Poor Patients
Bradley Weiner, MD1; 1Houston, TX, USA
BACKGROUND CONTEXT: Access to care for poor/near poor patients
is a concerning and growing problem within the American system of med-
ical care.
PURPOSE: The objective of this study was to examine the relationship
between health insurance status and access to spine care among patients
under 65 years of age eventually receiving treatment at our tertiary aca-
demic medical center in a semi-rural setting.
STUDY DESIGN/SETTING: Interview.
PATIENT SAMPLE: Sixty-four patients.
METHODS: Sixty-four consecutive spine surgical patients, eventually
managed at our center, all of whom had ‘Medicaid’ coverage were as-
sessed to determine the difficulties they encountered in receiving care prior
to seeing us including factors such as: refusal to be seen by a local provider
based upon insurance status and travel time/distance/cost/frequency to
eventually receive care at our center. The availability of local care for these
patients (fellowship trained spine surgeons in their local area) was also as-
sessed. These data were compared to similar patients with private, medi-
care, and worker’s compensation insurance.
RESULTS: The great majority of poor/near poor patients with Medicaid
coverage from counties at some distance from (and local to) our center
were referred/deferred on the basis of insurance status alone and most
had surgical problems which could have comfortably been addressed by
fellowship trained spine surgeons local to the patient. This difficulty in ac-
cess to care results in a significant burden (measured in time/travel/costs)
for these patients.
CONCLUSIONS: The poor/near poor with Medicaid insurance have less
access to local spine care than those with private health insurance, worker’s
compensation insurance, or medicare. The implications (from both surgeon
and patient perspectives) of this dilemma are discussed.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2007.07.030
24. Safety and Efficacy of Percutaneous Sacroplasty for Sacral
Insufficiency Fractures: A Prospective, Multi-center Trial with 2
Year Follow-up
Michael Frey, MD1, Michael DePalma, MD2, David Cifu, MD2,
Sarjoo Bhagia, MD3, Jonathan Daitch, MD4, William Carne5; 1Advanced
Pain Management Specialists, Fort Myers, FL, USA; 2Richmond, VA, USA;3Charolett, NC, USA; 4Fort Myers, FL, USA; 5VA, USA
BACKGROUND CONTEXT: Sacral insufficiency fractures (SIF) can
cause low back pain in osteoporotic patients. Symptomatic improvement
may require up to 12 months. Treatment includes limited weight-bearing
and bed rest, oral analgesics, and sacral corsets. Significant mortality
and morbidity are associated with pelvic insufficiency fractures. Percuta-
neous sacroplasty is an alternative treatment for SIF patients. Initial reports
have documented safe and effective performance of sacroplasty. Yet, fol-
low up intervals have been short (2-16 weeks), and study cohorts small
(N56). These findings do not allow definitive assessment of the safety
and efficacy of sacroplasty.
PURPOSE: To assess the safety and efficacy of sacroplasty in treating
osteoporotic SIF’s.
STUDY DESIGN/SETTING: A prospective observational cohort study
of consecutive osteoporotic SIF patients.
PATIENT SAMPLE: Patients present to multi-center private and aca-
demic centers presenting with pain related to sacral insufficiency fracture.
OUTCOME MEASURES: VAS scores were measured Pre-procedure,
Post-procedure and at 2, 4, 12, 24, 52, and 104 weeks post procedure.
Opiod analgesic use, nonopiod medication use, and patient satisfaction
were measured.
METHODS: Baseline VAS rating, analgesic usage, and duration of symp-
toms were recorded. Subsequent VAS ratings were assessed within 30 min-
utes after the procedure, at 2, 4, 12, 24, 52, and 104 weeks post-procedure.
Analgesic usage and patient satisfaction were assessed at final follow up.
Each procedure was performed under light intravenous conscious sedation
using fluoroscopy. Two bone trochars were inserted between the sacral fo-
ramen and sacroiliac joint through which 2-3cc’s of PMMA were injected.