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Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure
Not Recruiting
Trial ID: NCT03083886
Purpose
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.
Official Title
Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure - Randomized Clinical Trial
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- Patients with back or neck pain of ≤ 3 months' duration. All patients must have spine
pain with or without radiation to the extremities or the head
- Age ≥ 18 years
- Willing and able to provide informed consent
Exclusion Criteria:
- Patients with symptoms attributed to the spine but without actual pain in the spine
(e.g. those with cervicogenic headache without neck pain)
- Currently pregnant
- Currently receiving disability benefits, worker's compensation, or involved in
litigation for a workplace injury
- Currently enrolled in another intervention trial for the management of acute back or
neck pain
- Cancer that is metastatic or being actively treated. (i.e chemotherapy, radiation,
surgery)
- History of receiving active therapy for back or neck pain in the past 3 months (7+
consecutive days of narcotic use, 6+ sessions of PT, chiropractic care, acupuncture,
postural therapy, or other spine therapy delivered by a trained provider)
- History of spine surgery or spine injections/ablation in the past 6 months
- Severe, active psychosis or major depression inhibiting ability to physically
participate in intervention
- Red Flag Symptoms (fever, night sweats, unintentional weight loss, bowel or bladder
dysfunction, neurologic weakness, history of intravenous drug use)
Intervention(s):
other: Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care
other: Individualized Postural Therapy (IPT) + PCP led care
other: Usual PCP led care
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305