NCT06082739

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
42mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Nov 2023Oct 2029

First Submitted

Initial submission to the registry

October 9, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

November 6, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

4.9 years

First QC Date

October 9, 2023

Last Update Submit

January 15, 2025

Conditions

Kyphosis

Keywords

Scheuermann'sthoracolumbarposturalstretchingback

Outcome Measures

Primary Outcomes (1)

  • Kyphosis angle

    Change in severity of kyphosis angle evaluated using radiographs

    Enrollment, 6-month follow-up, 2-year follow-up

Secondary Outcomes (3)

  • Patient Satisfaction and Perception

    Enrollment, 6-month follow-up, 2-year follow-up

  • Parental Perception

    Enrollment, 6-month follow-up, 2-year follow-up

  • Exercise Adherence

    Enrollment, 6-month follow-up, 2-year follow-up

Study Arms (1)

Exercise group

EXPERIMENTAL

Patients perform stretching exercises daily.

Other: Exercises

Interventions

ExercisesOTHER

Stretching exercises with and without a bolster, ball, or foam roller.

Exercise group

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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."

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (7)

  • Priftis KN, Hager J, Vlachou M, Anthracopoulos MB. Effects of bracing on lung function in idiopathic juvenile kyphosis. Pediatr Pulmonol. 2003 Feb;35(2):83-6. doi: 10.1002/ppul.10220.

    PMID: 12526067BACKGROUND

  • Karavidas NS. Bracing for Adolescent Idiopathic Scoliosis (AIS) and Scheuermann Kyphosis: the issue of overtreatment in Greece. Scoliosis Spinal Disord. 2016 Oct 14;11(Suppl 2):30. doi: 10.1186/s13013-016-0095-6. eCollection 2016.

    PMID: 27785469BACKGROUND

  • Mehdikhani M, Behtash H, Ganjavian MS, Khalaj N. Orthotic treatment of idiopathic hyperkyphosis with Milwaukee brace. J Back Musculoskelet Rehabil. 2016 Aug 10;29(3):515-9. doi: 10.3233/BMR-150651.

    PMID: 26836834BACKGROUND

  • Pizzutillo PD. Nonsurgical treatment of kyphosis. Instr Course Lect. 2004;53:485-91.

    PMID: 15116637BACKGROUND

  • Riddle EC, Bowen JR, Shah SA, Moran EF, Lawall H Jr. The duPont kyphosis brace for the treatment of adolescent Scheuermann kyphosis. J South Orthop Assoc. 2003 Fall;12(3):135-40.

    PMID: 14577720BACKGROUND

  • Tsirikos AI, Jain AK. Scheuermann's kyphosis; current controversies. J Bone Joint Surg Br. 2011 Jul;93(7):857-64. doi: 10.1302/0301-620X.93B7.26129.

    PMID: 21705553BACKGROUND

  • Elpeze G, Usgu G. The Effect of a Comprehensive Corrective Exercise Program on Kyphosis Angle and Balance in Kyphotic Adolescents. Healthcare (Basel). 2022 Dec 8;10(12):2478. doi: 10.3390/healthcare10122478.

    PMID: 36554002BACKGROUND

MeSH Terms

Conditions

Kyphosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David L Skaggs, MD, MMM

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristabelle Alexander, BS

CONTACT

310-423-1061cristabelle.alexander@cshs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Spine Center

Study Record Dates

First Submitted

October 9, 2023

First Posted

October 13, 2023

Study Start

November 6, 2023

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2029

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)