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Which spine pain care model saves money and improves outcomes?

NCT ID NCT03083886

Knowledge-focused Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed study compared three approaches to treating recent back or neck pain: usual care from a primary care provider, usual care plus a coordinated decision-making model (ICE), and usual care plus individualized postural therapy (IPT). Over 3,000 adults with spine pain for less than three months took part. The goal was to see which model leads to lower healthcare costs and better pain and function after one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Care model (ICE decision-making or Individualized Postural Therapy) plus usual primary care
What this could lead to
If successful, this could show which care model is most cost-effective and helpful for acute spine pain, guiding doctors toward better, cheaper care.
What could go wrong
This is a completed pragmatic trial comparing care models, not a new drug or treatment. Results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

3,087 people

The number who actually took part.

Started

Jun 2017

Finished

Jun 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Back Pain Neck Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Back pain Neck pain

Contacts and locations

Locations

  • Augusto Focil, MD

    Oxnard, California, 93030, United States

  • Bernadette U. Iguh, MD

    Houston, Texas, 77051, United States

  • Carlos R. Herrera, MD

    Houston, Texas, 77013, United States

  • HonorHealth Medical Group

    Phoenix, Arizona, 85255, United States

  • Luis Zepeda, MD

    Houston, Texas, 77017, United States

  • Marwan A. Edris, MD

    Laguna Hills, California, 92653, United States

  • Teresa S. Sligh, MD

    North Hollywood, California, 91606, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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