22. The C.H.I.R.O. Study (Chiropractic Hospital-based Interventions Research Outcomes) Clinical...

1
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 O 3/5 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, PhD 1 , Jeffrey Quon, DC, MHSC, FCCSC 1 , David Olson, DC 1 , Don Nixdorf, DC 1 , Bradley Yee, DC, FCCS 1 , Marcel Dvorak, MD, FRCS 1 , Charles Fisher, MD, MHSC, FRCS 1 ; 1 University 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, MD 1 ; 1 Houston, 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, MD 1 , Michael DePalma, MD 2 , David Cifu, MD 2 , Sarjoo Bhagia, MD 3 , Jonathan Daitch, MD 4 , William Carne 5 ; 1 Advanced Pain Management Specialists, Fort Myers, FL, USA; 2 Richmond, VA, USA; 3 Charolett, NC, USA; 4 Fort Myers, FL, USA; 5 VA, 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. 11S Proceedings of the NASS 22nd Annual Meeting / The Spine Journal 7 (2007) 1S–163S

Transcript of 22. The C.H.I.R.O. Study (Chiropractic Hospital-based Interventions Research Outcomes) Clinical...

Page 1: 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

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.