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Completed

NCT Number: NCT03083886

Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure

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.

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Key information

Conditions

Back Pain Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HonorHealth Medical Group, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Usual PCP led care

Other

Primary care provider will direct patients' care pathway.

Primary outcomes

  1. Spine-related Cost of Care at One Year

    Time frame: One year

    Measured by patient self-report

  2. Change in Pain

    Time frame: Three months

    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

Secondary outcomes

  1. Change in Pain

    Time frame: One year

    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

  2. Quality of Life (EQ5D-5L VAS Scores)

    Time frame: One year

    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.

  3. Self-efficacy

    Time frame: One year

    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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Stanford University

Registry information

Official study title

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

Acronym: SPINE CARE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 20, 2017
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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