Spine clinical trials - Harvard/Stanford / Spine-Care

Status:

Open (Study open and enrolling)

ClinicalTrials.gov:

NCT03083886

CONDITION(S): Back Pain Neck Pain lumbar pain - TRIAL: SPINE-CARE - Spine Pain Intervention to Enhance Care Quality and Reduce Expenditure (SPINE-CARE).

Low back and neck pain are among the leading causes of medical visits, lost productivity and disability. There is an urgent need to identify effective and efficient ways of helping subjects with acute spine pain while guiding practitioners towards high-value care. This trial will be a block and cluster-randomized open-label multi-centered pragmatic randomized clinical trial comparing healthcare spending and clinical outcomes for subjects with spine pain of less than three months' duration, in whom there are no red flag signs or symptoms. Subjects will be randomized to one of three treatment strategies: (1) usual primary care provider-led care; (2) usual PCP-led care with spine pain treatment directed by the Identify, Coordinate, and Enhanced decision making (ICE) care model, and (3) usual PCP-led care with spine pain treatment directed by the Individualized Postural Therapy (IPT) care model. Our outcomes of interest will be spine-related healthcare utilization at one year as well as pain and functionality of the study participants

Drug

Other: Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care, Individualized Postural Therapy (IPT) + PCP led care, Usual PCP led care

Trial Type

Interventional

Age Range

18 years or older

Condition

Spine and back

Keywords

Back pain | Harvard | Stanford | SpineCare | Neck pain | acute spine pain | lumbar pain