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Managing Kyphosis With Exercise

Primary Purpose

Kyphosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercises
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kyphosis focused on measuring Scheuermann's, thoracolumbar, postural, stretching, back

Eligibility Criteria

8 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients ages 8-21 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 the patient ages 18 and older who are cognitively able to complete a survey will be included in the study as well. Exclusion Criteria: Patients with congenital kyphosis or scoliosis. Parents 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."

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Exercise group

    Arm Description

    Patients perform stretching exercises daily.

    Outcomes

    Primary Outcome Measures

    Kyphosis angle
    Change in severity of kyphosis angle evaluated using radiographs

    Secondary Outcome Measures

    Patient Satisfaction and Perception
    Patient Satisfaction and Perception measured via questionnaires
    Parental Perception
    Parental Perception of kyphosis measured via questionnaires
    Exercise Adherence
    Exercise Adherence measured via questionnaires

    Full Information

    First Posted
    October 9, 2023
    Last Updated
    October 9, 2023
    Sponsor
    Cedars-Sinai Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06082739
    Brief Title
    Managing Kyphosis With Exercise
    Official Title
    Effectiveness of Various Exercises in Managing Kyphosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2028 (Anticipated)
    Study Completion Date
    October 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cedars-Sinai Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kyphosis
    Keywords
    Scheuermann's, thoracolumbar, postural, stretching, back

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise group
    Arm Type
    Experimental
    Arm Description
    Patients perform stretching exercises daily.
    Intervention Type
    Other
    Intervention Name(s)
    Exercises
    Intervention Description
    Stretching exercises with and without a bolster, ball, or foam roller.
    Primary Outcome Measure Information:
    Title
    Kyphosis angle
    Description
    Change in severity of kyphosis angle evaluated using radiographs
    Time Frame
    Enrollment, 6-month follow-up, 2-year follow-up
    Secondary Outcome Measure Information:
    Title
    Patient Satisfaction and Perception
    Description
    Patient Satisfaction and Perception measured via questionnaires
    Time Frame
    Enrollment, 6-month follow-up, 2-year follow-up
    Title
    Parental Perception
    Description
    Parental Perception of kyphosis measured via questionnaires
    Time Frame
    Enrollment, 6-month follow-up, 2-year follow-up
    Title
    Exercise Adherence
    Description
    Exercise Adherence measured via questionnaires
    Time Frame
    Enrollment, 6-month follow-up, 2-year follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients ages 8-21 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 the patient ages 18 and older who are cognitively able to complete a survey will be included in the study as well. Exclusion Criteria: Patients with congenital kyphosis or scoliosis. Parents 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."
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cristabelle Ojukwu, BS
    Phone
    310-423-1061
    Email
    cristabelle.ojukwu@cshs.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David L Skaggs, MD, MMM
    Organizational Affiliation
    Cedars-Sinai Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    12526067
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27785469
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26836834
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15116637
    Citation
    Pizzutillo PD. Nonsurgical treatment of kyphosis. Instr Course Lect. 2004;53:485-91.
    Results Reference
    background
    PubMed Identifier
    14577720
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21705553
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    36554002
    Citation
    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.
    Results Reference
    background

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    Managing Kyphosis With Exercise

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