Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure (SPINE CARE)

Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure - Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Back Pain; Neck Pain
• Intervention / Treatment: Other: Usual PCP led care; Other: Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care; Other: Individualized Postural Therapy (IPT) + PCP led care

• Study Type: Interventional
• Enrollment (Actual): 3087
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85255
      • HonorHealth Medical Group
  • California
    • Laguna Hills, California, United States, 92653
      • Marwan A. Edris, MD
    • North Hollywood, California, United States, 91606
      • Teresa S. Sligh, MD
    • Oxnard, California, United States, 93030
      • Augusto Focil, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77013
      • Carlos R. Herrera, MD
    • Houston, Texas, United States, 77017
      • Luis Zepeda, MD
    • Houston, Texas, United States, 77051
      • Bernadette U. Iguh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual PCP led care	Other: Usual PCP led care; Primary care provider will direct patients' care pathway.
Experimental: Identify, Coordinated, Enhanced (ICE) Decision Making	Other: Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care; 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.
Experimental: Individualized Postural Therapy (IPT)	Other: Individualized Postural Therapy (IPT) + PCP led care; 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.

What is the study measuring?

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 The Oswestry Disability Index (ODI) captures pain related disability based on patient self-report. The ODI ranges from 0 (best) to 100 (worst). The Minimal clinically important difference (MCID) for ODI in patients with spine pain is 6 points. The change in participant-level pain related disability from baseline to 3 months using the Oswestry Disability Index has been reported. Reference: Fairbank JCT, Couper J, Davies JB, O'Brien JP. The Oswestry Low Back Pain Disability Questionnaire. Physiotherapy. 1980;66:271-273	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain	Measured by Oswestry Disability Index The Oswestry Disability Index (ODI) captures pain related disability based on patient self-report. The ODI ranges from 0 (best) to 100 (worst). The MCID for ODI in patients with spine pain is 6 points. The change in participant-level pain related disability from baseline to 12 months using the Oswestry Disability Index has been reported. Reference: Fairbank JCT, Couper J, Davies JB, O'Brien JP. The Oswestry Low Back Pain Disability Questionnaire. Physiotherapy. 1980;66:271-273	One year
Quality of Life (EQ5D-5L VAS Scores)	EuroQol 5-Dimensional Visual Analogue Scale (EQ-5D-5L VAS) by the EuroQol Group measures patient's self-rated health-related quality of life on a vertical visual analog scale. EQ-5D-5L VAS range from 0 to 100, with 100 indicating the best score. The MCID for the EQ-5D-5L visual analogue scale ranges from 5.3 to 10.5. The health-related quality of life at 12 months using the EQ-5D-5L VAS has been reported.	One year
Self-efficacy	The Lorig self-efficacy functioning sub-scale items ask individuals how confident they are in performing certain daily activities. Lorig self-efficacy functioning sub-scale scores range from 0 to 100, with 100 indicating the best score. The MCID for the Lorig self-efficacy scale has not been established. The patient-reported self-efficacy at 12 months using the Lorig self-efficacy functioning sub-scale has been reported. Reference: Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107. PMID: 2912463.	One year

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Stanford University
• Investigators: Principal Investigator: Niteesh K Choudhry, MD, PhD, Brigham and Women's Hospital

Publications and helpful links

General Publications

• Choudhry NK, Fontanet CP, Ghazinouri R, Fifer S, Archer KR, Haff N, Butterworth SW, Deogun H, Block S, Cooper A, Sears E, Goyal P, Coronado RA, Schneider BJ, Hsu E, Milstein A. Design of the Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure Trial (SPINE CARE) study: Methods and lessons from a multi-site pragmatic cluster randomized controlled trial. Contemp Clin Trials. 2021 Dec;111:106602. doi: 10.1016/j.cct.2021.106602. Epub 2021 Oct 22.
• Choudhry NK, Fifer S, Fontanet CP, Archer KR, Sears E, Bhatkhande G, Haff N, Ghazinouri R, Coronado RA, Schneider BJ, Butterworth SW, Deogun H, Cooper A, Hsu E, Block S, Davidson CA, Shackelford CE, Goyal P, Milstein A; SPINE CARE Investigators; Crum K, Scott J, Marton K, Silva FM, Obeidalla S, Robinette PE, Lorenzana-DeWitt M, Bair CA, Sadun HJ, Goldfield N, Hogewood LM, Sterling EK, Pickney C, Koltun-Baker EJ, Swehla A, Ravikumar V, Malhotra S, Finney ST, Holliday L, Moolman KC, Coleman-Dockery S, Patel IB, Angel FB, Green JK, Mitchell K, McBean MR, Ghaffar M, Ermini SR, Carr AL, MacDonald J. Effect of a Biopsychosocial Intervention or Postural Therapy on Disability and Health Care Spending Among Patients With Acute and Subacute Spine Pain: The SPINE CARE Randomized Clinical Trial. JAMA. 2022 Dec 20;328(23):2334-2344. doi: 10.1001/jama.2022.22625.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2017
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Neck Pain; Environment and Public Health; Inorganic Chemicals; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Anions; Ions; Electrolytes; Hydroxides; Alkalies; Oxides; Oxygen Compounds; Water; adenylate isopentenyltransferase; Ice
• Other Study ID Numbers: 2017P000622

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No