Managing Kyphosis With Exercise

Kyphosis Clinical Trial

Official title:

Effectiveness of Various Exercises in Managing Kyphosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06082739
• Other study ID #: STUDY00002960
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2023
• Est. completion date: October 2029

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: Cristabelle Ojukwu, BS
• Phone: 310-423-1061
• Email: cristabelle.ojukwu[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2029
• Est. primary completion date: October 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

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."

Related Conditions & MeSH terms

• Kyphosis

Intervention

Other:
• Exercises
Stretching exercises with and without a bolster, ball, or foam roller.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kyphosis angle	Change in severity of kyphosis angle evaluated using radiographs	Enrollment, 6-month follow-up, 2-year follow-up
Secondary	Patient Satisfaction and Perception	Patient Satisfaction and Perception measured via questionnaires	Enrollment, 6-month follow-up, 2-year follow-up
Secondary	Parental Perception	Parental Perception of kyphosis measured via questionnaires	Enrollment, 6-month follow-up, 2-year follow-up
Secondary	Exercise Adherence	Exercise Adherence measured via questionnaires	Enrollment, 6-month follow-up, 2-year follow-up