NCT06242821: AIS

Yoga for Back Pain in Adolescent Scoliosis

Recruiting now NA Last updated 16 January 2026

What this trial tests

NA trial testing Standard of Care (SOC) in Scoliosis Idiopathic Adolescent Treatment in 500 participants. Currently enrolling.

Timeline

1 January 2025

Primary endpoint
1 January 2027

1 March 2027

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	500
Start date	1 January 2025
Primary completion	1 January 2027
Estimated completion	1 March 2027
Sites	1 location across United States

Drugs / interventions tested

• Standard of Care (SOC) — full drug profile →
• Yoga

Conditions studied

• Scoliosis Idiopathic Adolescent Treatment — all drugs for Scoliosis Idiopathic Adolescent Treatment →
• Scoliosis Idiopathic — all drugs for Scoliosis Idiopathic →
• Scoliosis; Adolescence — all drugs for Scoliosis; Adolescence →
• Scoliosis — all drugs for Scoliosis →

Sponsor

Johns Hopkins University

Who can join

Adults 10 to 20, any sex, with Scoliosis Idiopathic Adolescent Treatment or Scoliosis Idiopathic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.