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Brace yourself: new study tests if back braces really work for scoliosis

NCT ID NCT00448448

Disease control Sponsor: Stuart L. Weinstein, MD 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether wearing a back brace can stop spine curves from getting worse in teens with scoliosis. About 383 teens with mild to moderate curves were either assigned to wear a brace for at least 18 hours a day or just be observed. The goal was to see if bracing leads to better outcomes by the time they reach skeletal maturity.

What this could mean

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

Active substance
Brace (TLSO)
What this could lead to
If successful, this could confirm that bracing effectively prevents scoliosis from worsening, reducing the need for surgery.
What could go wrong
The trial was terminated early, so results may be incomplete. Bracing requires wearing a brace 18+ hours daily, which can be uncomfortable and hard to maintain.

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

383 people

The number who actually took part.

Start date

Feb 2007

Finished

Sep 2013

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

10 to 15 years

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: * Diagnosis of AIS * Skeletally immature (Risser grade 0, 1, or 2) * Pre-menarchal or post-menarchal by no more than 1 year * Primary Cobb angle between 20 and 40 degrees * Curve apex caudal to T7 vertebrae * Physical and mental ability to adhere to bracing protocol * Ability to read and understand English, Spanish, or French * Documented insurance coverage and/or personal willingness to pay for treatment Exclusion Criteria: * Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature * History of previous surgical or orthotic treatment for AIS

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Conditions

The condition(s) this trial relates to.

adolescent idiopathic scoliosis

As listed by the trial registrant

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

Adolescent idiopathic scoliosis

Contacts and locations

Locations

  • Alfred I. duPont Hospital for Children and Nemours Children's Clinic

    Wilmington, Delaware, 19899, United States

  • BC Children's Hospital

    Vancouver, British Columbia, V6H 3V4, Canada

  • Carrie Tingley Hospital

    Albuquerque, New Mexico, 87102-1715, United States

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30342-4755, United States

  • Children's Hospital Boston

    Boston, Massachusetts, 02115, United States

  • Children's Hospital Central California

    Madera, California, 93638, United States

  • Children's Hospital and Regional Medical Center

    Seattle, Washington, 98105, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • Children's Mercy Hospitals and Clinics.

    Kansas City, Missouri, 64108, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Rady Childrens Hospital

    San Diego, California, 92123, United States

  • Shriner's Hospital for Children

    Chicago, Illinois, 60707, United States

  • Shriner's Hospital for Children

    Montreal, Quebec, Canada

  • Shriners Hospital of Northern California

    Sacramento, California, 95817, United States

  • Shriners Hospitals for Children - Lexington

    Lexington, Kentucky, 40502, United States

  • Shriners Hospitals for Children - Minneapolis

    Minneapolis, Minnesota, 55414, United States

  • Shriners Hospitals for Children - Salt Lake City

    Salt Lake City, Utah, 84103, United States

  • Shriners Hospitals for Children - St. Louis

    St Louis, Missouri, 63131, United States

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • University of Iowa Children's Hospital

    Iowa City, Iowa, 52242, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908-0232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.