Yoga for Back Pain in Adolescent Scoliosis

NCT06242821 | Recruiting

• 1 other identifier: IRB00423950
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Adolescent Idiopathic Scoliosis; yoga

Outcome Measures

Primary Outcomes (2)

• Pain and Quality of Life as assessed by the Scoliosis Research Society (SRS-22) questionnaire

  Possible score range from 0 (no pain)to 5(worst possible pain). A higher score indicates a better quality of life.

  Enrollment, 6 months, 1 year

• Participant Engagement

  Participant engagement will be measured by comparing attendance and adherence rates between the two groups to assess patient engagement with each intervention.

  Enrollment, 6 months, 1 year

Secondary Outcomes (1)

• Cobb Angle measurement

  Enrollment, 6 months, 1 yr

Study Arms (4)

Yoga Braced

ACTIVE COMPARATOR

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

Other: Yoga

Yoga - Not Braced

ACTIVE COMPARATOR

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

Other: Yoga

Braced - Standard of care

ACTIVE COMPARATOR

Patients who are braced, will be randomized into a group that will continue with their standard of care current treatment,

Other: Standard of Care (SOC)

Non Braced - Standard of care

ACTIVE COMPARATOR

Patients who are not braced, will be randomized into a group that will continue with their standard of care current treatment

Other: Standard of Care (SOC)

Interventions

Standard of Care (SOC) OTHER

Patients will continue with their current standard of care treatment.

Braced - Standard of care; Non Braced - Standard of care

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.

Yoga - Not Braced; Yoga Braced

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Non-operatively treated AIS patients at Johns Hopkins Hospital with back pain who are candidates for physical therapy.
• Cobb angle: greater than 25 degrees,
• Visual Analog Scale (VAS) Pain score greater than 41/0
• Braced and Unbraced Patients

You may not qualify if:

• Scoliosis due to causes other than AIS.
• AIS patients who have undergone surgery for scoliosis or back pain
• Age less than 10 years of age or greater than 20 years of age
• Unable to access zoom on any electronic device

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21230, United States

RECRUITING

MeSH Terms

Conditions

Scoliosis

Interventions

Standard of Care; Yoga

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Paul Sponseller, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra H Seidenstein, MD

CONTACT

410-502-3626; aseiden8@jh.edu

Gabrielle Reichard, MA

CONTACT

(410) 502- 3626; greicha1@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study aims to evaluate efficacy of a yoga-based intervention as an adjunct treatment for non-operative AIS patients, focusing on those who are braced and non-braced. This clinical trial seeks to provide valuable insights into alternative non-surgical treatment options for AIS.

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 5, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)