Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure

NCT03083886 | Completed Results

• 1 other identifier: 2017P000622
• Study Type: interventional
• Target: 3,087
• Locations: 1 country
• Sites: 8

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Pain

  One year

• Quality of Life (EQ5D-5L VAS Scores)

  One year

• Self-efficacy

  One year

Study Arms (3)

Usual PCP led care

ACTIVE COMPARATOR

Other: Usual PCP led care

Identify, Coordinated, Enhanced (ICE) Decision Making

EXPERIMENTAL

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

Individualized Postural Therapy (IPT)

EXPERIMENTAL

Other: Individualized Postural Therapy (IPT) + PCP led care

Interventions

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

Identify, Coordinated, Enhanced (ICE) Decision Making

Individualized Postural Therapy (IPT) + PCP led care 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.

Individualized Postural Therapy (IPT)

Usual PCP led care OTHER

Primary care provider will direct patients' care pathway.

Usual PCP led care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Stanford University: collaborator

Study Sites (8)

HonorHealth Medical Group

Phoenix, Arizona, 85255, United States

Location

Marwan A. Edris, MD

Laguna Hills, California, 92653, United States

Location

Teresa S. Sligh, MD

North Hollywood, California, 91606, United States

Location

Augusto Focil, MD

Oxnard, California, 93030, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Carlos R. Herrera, MD

Houston, Texas, 77013, United States

Location

Luis Zepeda, MD

Houston, Texas, 77017, United States

Location

Bernadette U. Iguh, MD

Houston, Texas, 77051, United States

Location

Related Publications (2)

• 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.

  PMID: 36538309 DERIVED

• 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.

  PMID: 34688915 DERIVED

MeSH Terms

Conditions

Back Pain; Neck Pain

Interventions

Ice; adenylate isopentenyltransferase

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Results Point of Contact

• Title: Niteesh Choudhry, MD, PhD
• Organization: Brigham and Women's Hospital

nkchoudhry@bwh.harvard.edu

617-278-0930

Study Officials

• Niteesh K Choudhry, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 20, 2017
• Study Start: June 5, 2017
• Primary Completion: March 31, 2021
• Study Completion: June 30, 2021
• Last Updated: September 17, 2025
• Results First Posted: September 17, 2025

Record last verified: 2025-09

Locations

US (8)