Managing Kyphosis With Exercise

January 15, 2025 updated by: David Skaggs, Cedars-Sinai Medical Center

Effectiveness of Various Exercises in Managing Kyphosis

The primary objective of this study is to determine if stretching exercises as a conservative treatment option will correct kyphosis in postural and Scheuermann's kyphosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Despite comprehensive documentation of surgical interventions in existing literature, the investigation into non-operative approaches for addressing hyperkyphosis or Scheuermann's kyphosis in the pediatric population has been investigated with inconsistent findings. Various outcomes have been observed with regard to the effectiveness of multiple brace treatment options, alongside recommendations for various physiotherapeutic approaches, either in conjunction with brace treatment or as standalone interventions.

However, there is no universally accepted consensus regarding the conservative management of kyphosis that simultaneously ensures substantial patient satisfaction and heightened bodily awareness. Notably, there have been no studies investigating the efficacy of stretching in the treatment of individuals with kyphosis.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • David L Skaggs, MD, MMM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients ages 8 and older with postural or Scheuermann's kyphosis with >45° of kyphosis or >10° of thoracolumbar kyphosis from T11-L1 or other cases which seem to have excessive kyphosis.
  • Parents of patients aged 17 and younger who are 18 and older and cognitively able to complete a survey will be included in the study as well.

Exclusion Criteria:

  • Patients with congenital kyphosis or scoliosis greater than 30°.
  • Parents of patients aged 17 and younger who are less than 18 years of age or cognitively unable to complete a survey will be excluded from the study.
  • Any records flagged "break the glass" or "research opt out."

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise group
Patients perform stretching exercises daily.
Other: Exercises
Stretching exercises with and without a bolster, ball, or foam roller.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kyphosis angle
Time Frame: Enrollment, 6-month follow-up, 2-year follow-up
Change in severity of kyphosis angle evaluated using radiographs
Enrollment, 6-month follow-up, 2-year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction and Perception
Time Frame: Enrollment, 6-month follow-up, 2-year follow-up
Patient Satisfaction and Perception measured via questionnaires
Enrollment, 6-month follow-up, 2-year follow-up
Parental Perception
Time Frame: Enrollment, 6-month follow-up, 2-year follow-up
Parental Perception of kyphosis measured via questionnaires
Enrollment, 6-month follow-up, 2-year follow-up
Exercise Adherence
Time Frame: Enrollment, 6-month follow-up, 2-year follow-up
Exercise Adherence measured via questionnaires
Enrollment, 6-month follow-up, 2-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: David L Skaggs, MD, MMM, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002960

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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