Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparative Effectiveness of Management Strategies for Acute Low Back Pain
Brief Summary: Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped care approach with initial treatment of education and advice to remain active. Referral to physical therapy is considered only when patients fail to recover after a few weeks. Recent research has led to the identification a subgroup of patients likely to experience rapid, pronounced, and sustained decreases in disability and pain with a brief manipulation and exercise intervention, suggesting it may be more cost-effective to manage this sub-group with early referral to physical therapy instead of the usual care approach. The integration of this evidence into routine practice has not been evaluated. We will assess the outcomes of integrating this evidence into the management of patients with low back pain. The study is a randomized trial, comparing management with early manipulation with the current care process model. Patients fitting the inclusion criteria will be randomized into one of two groups. One group will be managed with the current care process model. The other group will be managed consistent with the decision rule recommending early referral for a brief manipulation and exercise intervention during the first 4 weeks. Patients will be followed over 1 year. Outcomes will include measures of disability, pain, satisfaction, and direct medical costs. The study will examine the costs and effectiveness of integrating the alternative care model into practice.


Options:
A: Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual Care | Arm Label: Early Physical Therapy with Usual Care; Type: EXPERIMENTAL; Interventions: Other: Early Physical Therapy with Usual Care, Other: Usual Care | Intervention Type: OTHER; Name: Early Physical Therapy with Usual Care; Assigned to Arm(s): Early Physical Therapy with Usual Care | Intervention Type: OTHER; Name: Usual Care; Assigned to Arm(s): Early Physical Therapy with Usual Care, Usual Care
B: Arm Label: Usual Care (UC); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Usual Care (UC) | Arm Label: Early Physical Therapy (PT); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Early Physical Therapy (PT) | Intervention Type: PROCEDURE; Name: Usual Care (UC); Assigned to Arm(s): Usual Care (UC) | Intervention Type: PROCEDURE; Name: Early Physical Therapy (PT); Assigned to Arm(s): Early Physical Therapy (PT)
C: Arm Label: Thermal care; Type: EXPERIMENTAL; Interventions: Device: Thermal care, Behavioral: Education for the management of acute low back pain | Arm Label: Thermal care + exercises; Type: EXPERIMENTAL; Interventions: Device: Thermal care, Other: Exercises, Behavioral: Education for the management of acute low back pain | Arm Label: Control; Type: SHAM_COMPARATOR; Interventions: Device: Sham, Behavioral: Education for the management of acute low back pain | Intervention Type: DEVICE; Name: Thermal care; Assigned to Arm(s): Thermal care, Thermal care + exercises | Intervention Type: OTHER; Name: Exercises; Assigned to Arm(s): Thermal care + exercises | Intervention Type: DEVICE; Name: Sham; Assigned to Arm(s): Control | Intervention Type: BEHAVIORAL; Name: Education for the management of acute low back pain; Assigned to Arm(s): Control, Thermal care, Thermal care + exercises
D: Arm Label: Low Back Only; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Low Back Only | Arm Label: Low Back+Hip; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Low Back+Hip | Intervention Type: PROCEDURE; Name: Low Back Only; Assigned to Arm(s): Low Back Only | Intervention Type: PROCEDURE; Name: Low Back+Hip; Assigned to Arm(s): Low Back+Hip

Answer: A