Yoga for Back Pain in Adolescent Scoliosis

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06242821
Status
Recruiting
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Conditions

  • Scoliosis
  • Scoliosis Idiopathic
  • Scoliosis Idiopathic Adolescent Treatment
  • Scoliosis; Adolescence

Eligibility Criteria

Sex
ALL
Age
10 Years - 20 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care (SOC) — OTHER
    Patients will continue with their current standard of care treatment.
  • Yoga — OTHER
    Patients will be randomized to participate in the Yoga intervention. This will consist of online 20 min yoga classes, 2 times per week. The class will be a set protocol, and patients will be given the protocol to do at home if desired.

Study Details

The Problem: Adolescent Idiopathic Scoliosis (AIS), the pre-eminent spinal pathology affecting over 5% of children and adolescents, presents a pronounced spinal curvature exceeding 10 degrees, with prevalence amongst female adolescents at a ratio of 3:1 compared to males. A significant portion of these patients are not immediate candidates for surgical intervention. The acute shortage of viable non-operative management strategies, which is becoming increasingly imperative given the current barriers to physical therapy access and the growing opioid crisis. The investigator's research intends to explore the addition of a structured yoga protocol to standard of care. This research will thus explore the potential for improved relief and quality-of-life improvements for AIS patients not ready for surgery. Significance: AIS is a pervasive condition which correlates with chronic and episodic lower back pain, diminished sleep quality, and depressive symptoms. This extensive comorbid association coupled with the financial pressure to patients and the healthcare system cannot be understated. Needs Statement: There is a lack of sufficient non-operative management options for AIS. Many patients face limited access and require supplementary management strategies to address the patient's conditions effectively, creating a significant unmet need for non-pharmacological pain management interventions. This need is further highlighted in the context of the escalating opioid crisis, a leading cause of death among adolescents and young adults. Hypothesis: The introduction of a structured yoga protocol can serve as a non-inferior or even superior alternative to traditional standard of care i management of AIS, addressing both the physical and psychosocial aspects intertwined with the condition. IMPACT: Change in Problem Significance: This research trial aims to enhance current standard of care for patients grappling with AIS. If the trial demonstrates superiority of yoga, it will delineate a paradigm shift in the current care standards for AIS patients, fostering a move towards a more cost-effective and holistic approach. Yoga could help alleviate the burdens on the healthcare system by reducing costs and enhancing accessibility for patients. Improvement in Pediatric Orthopedics Practice: By paving the way for non-pharmacological interventions, the trial aspires to mitigate the reliance on opioids for pain management in the pediatric demographic, therefore promoting overall well-being. This project not only seeks to develop alternative pain management strategies amidst a growing opioid epidemic but also champions the cause of improving the quality of life for the pediatric population battling chronic conditions like AIS. It echoes the urgent call to innovate and expand upon the current strategies in place, steering the medical community towards a future where integrative approaches are not the exception but the norm. Ultimately, this research aspires to guide the trajectory of pediatric orthopedics towards a healthcare system that is more inclusive, accessible, and holistically oriented, thereby enhancing the quality of life for pediatric patients grappling with conditions like AIS. 2\. Objectives (include all primary and secondary objectives) Goals/Objectives: To create a randomized clinical trial aimed to evaluate the efficacy of yoga in conjunction with standard of care treatments for AIS patients. SPECIFIC AIMS Aim 1: Evaluate the feasibility and challenges of implementing a yoga protocol for AIS patients. Methodology: Online class attendance, survey completions, and follow-up appointments. Anticipated Results: Adequate participant adherence and data reliability. Aim 2: Compare clinical outcomes between patients who receive traditional care modalities versus those who added yoga to treatment plan. Methodology: Utilize validated tools such as the SRS-22 questionnaire and monitor outcomes including depression scale, sleep quality, analgesic usage, activity levels, and Cobb angle. Anticipated Results: Significant physical and psychological improvements in the yoga group.

Key Dates

Start date
Jan 1, 2025
Status verified
Jan 2026
Primary completion
Jan 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Yoga Braced
    Patients, who are currently wearing a brace, are randomized into the yoga group will partake in an online 20 min yoga class 2 days per week
  • Active Comparator: Yoga - Not Braced
    Patients, who are currently not wearing a brace, are randomized into the yoga group will partake in an online 20 min yoga class 2 days per week
  • Active Comparator: Braced - Standard of care
    Patients who are braced, will be randomized into a group that will continue with their standard of care current treatment,
  • Active Comparator: Non Braced - Standard of care
    Patients who are not braced, will be randomized into a group that will continue with their standard of care current treatment

Primary Outcome Measure

Pain and Quality of Life as assessed by the Scoliosis Research Society (SRS-22) questionnaire [ Time Frame: Enrollment, 6 months, 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21230
Alexandra Seidenstein, MD, PhD
[email protected]
443-997-5437
Gabrielle Reichard, MS
[email protected]
443-997-5437
Alexandra Seidenstein, MD PhD (PRINCIPAL_INVESTIGATOR)

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