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Clinical Trials/NCT06082739
NCT06082739RecruitingNot Applicable

Effectiveness of Various Exercises in Managing Kyphosis

Cedars-Sinai Medical Center2 sites in 1 country120 target enrollmentStarted: November 6, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
120
Locations
2
Primary Endpoint
Kyphosis angle

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
8 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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."

Outcomes

Primary Outcomes

Kyphosis angle

Time Frame: Enrollment, 6-month follow-up, 2-year follow-up

Change in severity of kyphosis angle evaluated using radiographs

Secondary Outcomes

  • Parental Perception(Enrollment, 6-month follow-up, 2-year follow-up)
  • Exercise Adherence(Enrollment, 6-month follow-up, 2-year follow-up)
  • Patient Satisfaction and Perception(Enrollment, 6-month follow-up, 2-year follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David Skaggs

Director Spine Center

Cedars-Sinai Medical Center

Study Sites (2)

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