Back Pain Management in AIS: Yoga vs Physical Therapy

Scoliosis Clinical Trial

— AIS  

Official title:

Back Pain Management in AIS: Yoga vs Physical Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06242821
• Other study ID #: IRB00423950
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 25, 2024
• Est. completion date: March 2026

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: Alexandra H Seidenstein, MD
• Phone: 410-502-3626
• Email: aseiden8[@]jh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Targeting non-operative Adolescent Idiopathic Scoliosis (AIS) patients, including those who are braced and non-braced, this research project at Johns Hopkins Hospital seeks to revolutionize the treatment approach for Adolescent Idiopathic Scoliosis. This innovative study compares traditional physical therapy with a yoga-based intervention, focusing on alleviating back pain and enhancing quality of life in this specific patient group. This research is anchored in substantial existing evidence that highlights the physiological and psychological benefits of yoga and is in alignment with current AIS treatment strategies.

Addressing the urgent need for diverse non-operative management strategies for AIS, this study is particularly timely given the challenges in accessing physical therapy and the growing concerns over opioid use. The investigators exploration of structured yoga protocols aims to introduce a viable alternative therapy, providing significant relief and improving the quality of life for AIS patients who are not candidates for surgery. By integrating cutting-edge healthcare solutions with the increasing interest in yoga in the U.S., this project aims to establish a new benchmark in non-surgical AIS treatment that is both effective and accessible to a wide range of patients

Description:

Adolescent Idiopathic Scoliosis (AIS) affects over 5% of children, about 3 million new cases of the condition are diagnosed in the United States per year, and is a major health challenge. Characterized by a pronounced spinal curvature, predominantly in female adolescents, AIS leads to back pain and other complications. These issues not only strain patients but also place significant demands on the healthcare system, underscoring the need for effective, accessible non-operative treatments.

A critical gap exists for patients with curvature levels below surgical thresholds, who lack viable non-operative management options. This issue is exacerbated by limited access to physical therapy and concerns over pharmaceutical treatments for pain management. This study targets this gap, proposing to evaluate structured yoga protocols as an alternative intervention for AIS patients not ready for surgery. The project builds on research highlighting yoga's physiological and psychological benefits, aligning with current AIS treatment strategies. The significance of this research lies in its potential to transform the standard of care for AIS. Should yoga prove superior or non-inferior to physical therapy, it could herald a paradigm shift towards a more holistic, cost-effective approach. This shift would not only alleviate healthcare system burdens by reducing costs but also improve accessibility for patients with limited physical therapy options.

This trial aspires to pave the way for non-pharmacological interventions in pediatric orthopedics, particularly important in light of the growing opioid crisis. By offering an alternative pain management strategy, this project supports the well-being of the pediatric population with chronic conditions like AIS. It resonates with the urgent need to innovate and expand current strategies, guiding the medical community towards integrative approaches as a norm rather than an exception. Ultimately, this research aims to steer pediatric orthopedics towards a more inclusive, accessible, and holistic healthcare system, thereby enhancing the quality of life for pediatric patients with AIS.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 20 Years

Eligibility

Inclusion Criteria:

• Non-operatively treated AIS patients at JHH with back pain who are candidates for physical therapy.

• Cobb angle: greater than 25 degrees, VAS Pain score greater than 41/0

• Braced and Unbraced Patients

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Back Pain
• Scoliosis
• Scoliosis Idiopathic
• Scoliosis; Adolescence

Intervention

Other:
• Observation
Patients who chose to be part of the study, but do not wish to participate in PT or Yoga, will be monitored with routine imagine, and survey follow up.
• Physical Therapy
Patients will either be randomized or self select to participate in Physical Therapy as per standard of care for non-operative AIS.
• Yoga
Patients will either be randomized or self select to participate in the Yoga intervention. This will consist of online 20 min yoga classes, 2 times per week for 6 months. The class will be a set protocol, and patients will be given the protocol to do at home if desired.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Cobb Angle measurement	Patients will have cobb angle (extent of scoliotic curve) measured	Enrollment, 6 months, 1 yr