The Chiropractic Hospital-based Interventions Research Outcomes (CHIRO) Study: a randomized controlled trial on the effectiveness of clinical practice guidelines in the medical and chiropractic management of patients with acute mechanical low back pain
ABSTRACT Evidence-based clinical practice guidelines (CPGs) for the management of patients with acute mechanical low back pain (AM-LBP) have been defined on an international scale. Multicenter clinical trials have demonstrated that most AM-LBP patients do not receive CPG-based treatments. To date, the value of implementing full and exclusively CPG-based treatment remains unclear.
To determine if full CPGs-based study care (SC) results in greater improvement in functional outcomes than family physician-directed usual care (UC) in the treatment of AM-LBP.
A two-arm, parallel design, prospective, randomized controlled clinical trial using blinded outcome assessment. Treatment was administered in a hospital-based spine program outpatient clinic.
Inclusion criteria included patients aged 19 to 59 years with Quebec Task Force Categories 1 and 2 AM-LBP of 2 to 4 weeks' duration. Exclusion criteria included "red flag" conditions and comorbidities contraindicating chiropractic spinal manipulative therapy (CSMT).
Primary outcome: improvement from baseline in Roland-Morris Disability Questionnaire (RDQ) scores at 16 weeks. Secondary outcomes: improvements in RDQ scores at 8 and 24 weeks; and in Short Form-36 (SF-36) bodily pain (BP) and physical functioning (PF) scale scores at 8, 16, and 24 weeks.
Patients were assessed by a spine physician, then randomized to SC (reassurance and avoidance of passive treatments, acetaminophen, 4 weeks of lumbar CSMT, and return to work within 8 weeks), or family physician-directed UC, the components of which were recorded.
Ninety-two patients were recruited, with 36 SC and 35 UC patients completing all follow-up visits. Baseline prognostic variables were evenly distributed between groups. The primary outcome, the unadjusted mean improvement in RDQ scores, was significantly greater in the SC group than in the UC group (p=.003). Regarding unadjusted mean changes in secondary outcomes, improvements in RDQ scores were also greater in the SC group at other time points, particularly at 24 weeks (p=.004). Similarly, improvements in SF-36 PF scores favored the SC group at all time points; however, these differences were not statistically significant. Improvements in SF-36 BP scores were similar between groups. In repeated-measures analyses, global adjusted mean improvement was significantly greater in the SC group in terms of RDQ (p=.0002), nearly significantly greater in terms of SF-36 PF (p=.08), but similar between groups in terms of SF-36 BP (p=.27).
This is the first reported randomized controlled trial comparing full CPG-based treatment, including spinal manipulative therapy administered by chiropractors, to family physician-directed UC in the treatment of patients with AM-LBP. Compared to family physician-directed UC, full CPG-based treatment including CSMT is associated with significantly greater improvement in condition-specific functioning.
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Technical Report: Evaluation de l'efficacité de la pratique de la chiropratique
- JCCA. Journal of the Canadian Chiropractic Association. Journal de l'Association chiropratique canadienne 03/2011; 55(1):20-2.
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ABSTRACT: Systematic review of spine care pathways and case study of the Saskatchewan Spine Pathway (SSP). (1) What are the differences between clinical pathways and clinical guidelines? (2) Are there examples of clinical pathways in the management of lower back pain (LBP)? Is there evidence that they are successful? (3) What is the SSP, and what are its key features? Adherence to evidence-based guidelines for LBP produces superior outcomes and may improve efficiency by reducing unnecessary imaging, ineffective treatments, and inappropriate surgical referrals. A clinical pathway is an attempt to bridge the "translation gap" between guidelines and clinical practice. A qualitative review was performed for question 1. For question 2, a systematic review of the English language literature was performed for articles published through March 31, 2011. A case study is provided for question 3. (1) Evidence for clinical pathways is mainly derived from guidelines, but pathways are distinguished by several features including the coordination of multidisciplinary care, facilitation of communication among care providers, resources for ongoing quality improvements, and a central focus on the patient experience. (2) Five articles describing four clinical pathways met the a priori criteria, but none tested comparative effectiveness. (3) The SSP is unique in that it is (a) inclusive for all types of LBP, (b) based on a classification system, (c) patient-focused mostly at primary care rather than in specialized clinics, (d) implemented in the health care system of a geopolitically defined region, and (e) includes all of the defining features of modern care pathways. Several clinical pathways for LBP have been described, but effectiveness has not been tested. Clinical pathways for LBP need to be further developed and investigated as a means to facilitate guidelines-concordant practice and improve patient outcomes. Level of evidence: Insufficient. Recommendation: Weak.Spine 10/2011; 36(21 Suppl):S164-71. DOI:10.1097/BRS.0b013e31822ef58f · 2.45 Impact Factor