Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure

Study Overview
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Brief Summary
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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
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Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure - Randomized Clinical Trial

Conditions
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Back Pain, Neck Pain

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


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual PCP led care<br> | Other: Usual PCP led care<br>* Primary care provider will direct patients' care pathway.<br>|
| Experimental: Identify, Coordinated, Enhanced (ICE) Decision Making<br> | Other: Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care<br>* Subjects seeking care at a clinic assigned to this arm will receive the ICE care model through referral by their primary care provider. The ICE care model was developed by the Clinical Excellence Research Center at Stanford University based on a review of the peer-reviewed literature for adult subjects with incident neck or back pain less than six weeks in duration who are not using high-dose opioid medications or receiving spine-related long-term disability payments.<br>|
| Experimental: Individualized Postural Therapy (IPT)<br> | Other: Individualized Postural Therapy (IPT) + PCP led care<br>* IPT involves the evaluation of a subject's posture to identify postural and alignment deviations and, based on this, a personalized corrective exercise program is prescribed. This method does involve the use of prescription medications, surgery, or manipulation. A treatment course typically lasts eight sessions over eight weeks. In order to allow for the consistent delivery of this arm of the study at multiple study-sites across the country, IPT will be delivered by The Egoscue Method. Egoscue was founded in 1971 and has 25 clinics worldwide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spine-related cost of care at one year | Measured by patient self-report | One year | 
| Change in pain | Measured by Oswestry Disability Index | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | Measured by Oswestry Disability Index | One year | 
| Quality of life | Measured by EuroQol- 5 Dimension (EQ-5D) questionnaire | One year | 
| Self-efficacy | Measured by scale developed by Lorig et al. | One year |