Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure

Not Recruiting

Trial ID: NCT03083886


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)


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,

   - 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)


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