Clinical trial NCT06082739: Managing Kyphosis With Exercise
Official title: Effectiveness of Various Exercises in Managing Kyphosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kyphosis
Keywords: Scheuermann's
thoracolumbar
postural
stretching
back
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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."

Primary outcomes:
measure: Kyphosis angle
timeFrame: Enrollment, 6-month follow-up, 2-year follow-up
Secondary outcomes:
measure: Patient Satisfaction and Perception
timeFrame: Enrollment, 6-month follow-up, 2-year follow-up
measure: Parental Perception
timeFrame: Enrollment, 6-month follow-up, 2-year follow-up
measure: Exercise Adherence
timeFrame: Enrollment, 6-month follow-up, 2-year follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: David L Skaggs, MD, MMM
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: Pizzutillo PD. Nonsurgical treatment of kyphosis. Instr Course Lect. 2004;53:485-91.
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.
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.
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.