Managing Kyphosis With Exercise

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 8 Years - 21 Years
Gender All
More Inclusion & Exclusion 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.
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Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06082739
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Cedars-Sinai Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David L Skaggs, MD, MMM
Principal Investigator Affiliation Cedars-Sinai Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Kyphosis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Exercise group

Patients perform stretching exercises daily.

Interventions

Other: - Exercises

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cedars-Sinai Medical Center, Los Angeles, California

Status

Recruiting

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Site Contact

Cristabelle Alexander, BS

[email protected]

310-423-1061