Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure

NCT ID: NCT03083886

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3087 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-05
• Study Completion Date: 2021-06-30

Brief Summary

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.

Conditions

Back Pain; Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual PCP led care

Group Type: ACTIVE_COMPARATOR

Usual PCP led care

Intervention Type: OTHER

Primary care provider will direct patients' care pathway.

Identify, Coordinated, Enhanced (ICE) Decision Making

Group Type: EXPERIMENTAL

Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care

Intervention Type: OTHER

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.

Individualized Postural Therapy (IPT)

Group Type: EXPERIMENTAL

Individualized Postural Therapy (IPT) + PCP led care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Usual PCP led care

Primary care provider will direct patients' care pathway.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Niteesh K. Choudhry, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Niteesh K Choudhry, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

HonorHealth Medical Group

Phoenix, Arizona, United States

Marwan A. Edris, MD

Laguna Hills, California, United States

Teresa S. Sligh, MD

North Hollywood, California, United States

Augusto Focil, MD

Oxnard, California, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Carlos R. Herrera, MD

Houston, Texas, United States

Luis Zepeda, MD

Houston, Texas, United States

Bernadette U. Iguh, MD

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36538309 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34688915 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2017P000622

Identifier Type: -

Identifier Source: org_study_id