Yoga for Scoliosis

(AIS Trial)

Overseen By Gabrielle Reichard, MA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Non-AIS scoliosis, Surgery, Age, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on adding yoga to your existing treatment plan, so it's likely you can continue your current medications, but you should confirm with the trial coordinators.

What data supports the effectiveness of the treatment Yoga for Scoliosis?

Research suggests that specific yoga poses can help improve scoliosis in adolescents, similar to how other exercise programs have shown to reduce spinal curvature and improve quality of life in people with scoliosis. ^{1 2 3 4 5}

Is yoga safe for people with scoliosis?

The research does not specifically address the safety of yoga for scoliosis, but yoga is generally considered safe for most people when practiced correctly. It's important to consult with a healthcare provider before starting any new exercise program, especially if you have a medical condition like scoliosis. ^{1 5 6 7 8}

How does yoga differ from other treatments for scoliosis?

Yoga for scoliosis, specifically using the side plank pose, focuses on asymmetrical strengthening of the trunk muscles on the convex side of the scoliotic curve, which is different from other treatments that typically aim to realign the spine through muscle relaxation or stretching. This approach is unique because it targets muscle strengthening rather than just alignment or flexibility. ^{9 10 11 12 13}

Research Team

Paul Sponseller, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

This trial is for adolescents with a pronounced spinal curvature (Cobb angle over 25 degrees) and significant back pain, who are being treated non-surgically for Adolescent Idiopathic Scoliosis at JHH. It includes those undergoing physical therapy, both braced and unbraced patients.

Inclusion Criteria

I have back pain from AIS and am eligible for physical therapy without surgery.

My spine curve is over 25 degrees and my pain score is more than 4.

I am either wearing a brace or not wearing a brace.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into groups to receive either standard care or standard care with yoga. Yoga sessions are conducted online twice a week for 20 minutes.

6 months

Online sessions twice a week

Follow-up

Participants are monitored for pain, quality of life, and Cobb angle changes at 6 months and 1 year.

6 months

Assessments at 6 months and 1 year

Long-term Follow-up

Participants continue to be monitored for long-term outcomes and engagement.

1 year

Treatment Details

Interventions

• Yoga

Trial Overview The study tests the effectiveness of adding a structured yoga protocol to the standard care for managing AIS. Participants will be randomly assigned to either continue with their usual treatment or incorporate yoga into their regimen.

Participant Groups

Group I: Yoga Braced Active Control 1 Intervention

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

Group II: Yoga - Not Braced Active Control 1 Intervention

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

Group III: Braced - Standard of care Active Control 1 Intervention

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

Group IV: Non Braced - Standard of care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

A nonrandomized control trial involving 56 adolescents with idiopathic scoliosis showed that specific yoga poses significantly reduced the Cobb angles, indicating improvement in spinal curvature, with a mean change of -9.2 degrees in the treatment group compared to a deterioration of 5.4 degrees in the control group.

Patients receiving yoga treatment in-office experienced greater improvements (1.6 degrees/month) compared to those using telemedicine (0.72 degrees/month), suggesting that while both methods were beneficial, in-person sessions may lead to better adherence and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isometric Yoga-Like Maneuvers Improve Adolescent Idiopathic Scoliosis-A Nonrandomized Control Trial. Fishman, LM.[2022]

In a study of 74 adolescents with idiopathic scoliosis, those who participated in the Scientific Exercises Approach to Scoliosis (SEAS) had a significantly lower rate of brace prescriptions (6.1%) compared to those receiving usual care (25.0%).

The SEAS exercises not only reduced the need for bracing but also led to improvements in Cobb angle measurements, with 23.5% of patients improving, while the usual physiotherapy group saw a worsening in their Cobb angles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specific exercises reduce brace prescription in adolescent idiopathic scoliosis: a prospective controlled cohort study with worst-case analysis. Negrini, S., Zaina, F., Romano, M., et al.[2022]

Core-based exercise has been shown to significantly reduce the Cobb angle, a measure of spinal curvature, in individuals with scoliosis, based on a systematic review of nine studies involving 325 participants.

Participants engaging in core-based exercise also reported improved quality of life, as indicated by the Scoliosis Research Society-22 questionnaire, with no serious adverse events noted, suggesting that this intervention is safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of core-based exercise in people with scoliosis: A systematic review and meta-analysis. Li, X., Shen, J., Liang, J., et al.[2022]

In a study of 107 patients with idiopathic scoliosis, a 4-6 week inpatient exercise program led to a significant reduction in the average curvature of the spine, from 43.06 degrees to 38.96 degrees as measured by the Cobb technique.

Approximately 44% of patients experienced an improvement of 5 degrees or more in their spinal curvature, demonstrating that targeted physiotherapy can effectively reduce curvature even in severe cases of scoliosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of an in-patient exercise program on scoliotic curve. Weiss, HR.[2022]

A short-term Schroth exercise camp significantly improved trunk rotation angle, postural symmetry, trunk muscle endurance, and dynamic balance in 45 adolescents with idiopathic scoliosis after just 7 days of intensive corrective exercises.

Participants also reported better perceptions of cosmetic deformity and improved health-related quality of life, indicating that the Schroth method may be an effective intervention for managing symptoms of adolescent idiopathic scoliosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Short-Term 3-Dimensional Schroth Exercises In Adolescent Idiopathic Scoliosis: An Observational Study. Aktan, D., Erdoganoglu, Y.[2022]

A systematic review of 15 studies, including six randomized controlled trials, found that exercise therapy positively impacts lung volumes and pulmonary function in patients with Adolescent Idiopathic Scoliosis (AIS).

Despite the positive findings, many studies had only 'fair' quality, indicating a need for more robust clinical trials to confirm these benefits and better understand the effects of exercise therapy on pulmonary function in AIS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does exercise therapy improve pulmonary function in patients with Adolescent Idiopathic Scoliosis? Rafferty, A., Fleming, N., Kiely, P., et al.[2023]

A review of 12 relevant studies on exercise therapy for adolescent idiopathic scoliosis (AIS) found that while all studies supported its use, the evidence was of poor quality with significant methodological shortcomings.

Many studies reported small improvements in the curvature of the spine (Cobb angle) after exercise therapy, but these changes were not statistically robust and lacked long-term follow-up, indicating a need for better-designed research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of exercise therapy for the treatment of adolescent idiopathic scoliosis: a review of the literature. Mordecai, SC., Dabke, HV.[2022]

Bracing is a common conservative treatment for idiopathic scoliosis (IS) in adolescents, with evidence supporting its effectiveness, although the quality of this evidence is low; full-time bracing is more effective than part-time, and combining bracing with exercises may yield the best results.

Despite the potential benefits of exercises as an adjunctive treatment for IS, the quality of evidence is also low, and there is a lack of consensus among experts regarding the best types of braces and their effectiveness, highlighting challenges in patient recruitment for clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Actual evidence in the medical approach to adolescents with idiopathic scoliosis. Negrini, S., De Mauroy, JC., Grivas, TB., et al.[2018]

In a study involving 18 females with adolescent idiopathic scoliosis, prior muscle stretching negatively impacted their ability to maintain proper lower trunk alignment during posture exercises, with a significant change in alignment observed after stretching.

The results suggest that practitioners should avoid incorporating stretching immediately before posture maintenance exercises, as it may hinder performance without affecting perceived effort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute muscle stretching and the ability to maintain posture in females with adolescent idiopathic scoliosis. Levi, D., Springer, S., Parmet, Y., et al.[2019]

A hypopressive gymnastics (HG) program applied to three children aged 8 to 15 with idiopathic scoliosis showed a trend towards stabilization of vertebral tilt and rotation after three months of daily exercises.

The program also indicated potential improvements in rib cage deformation (gibbosity) and respiratory function, suggesting that HG exercises may help control the progression of dorsal idiopathic scoliosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary study on the action of hypopressive gymnastics in the treatment of idiopathic scoliosis]. Caufriez, M., Fernández-Domínguez, JC., Brynhildsvoll, N.[2022]

A study involving 36 patients with idiopathic scoliosis showed that adding a new exercise program focused on correcting sagittal profiles (physio-logic exercises) significantly reduced lateral trunk deviation compared to standard Scoliosis Intensive Rehabilitation (SIR) alone.

While the physio-logic exercises improved lateral deviation and surface rotation, they did not lead to significant changes in kyphosis angle, indicating that while beneficial, further research is needed to assess long-term effects and overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving excellence in scoliosis rehabilitation: a controlled study of matched pairs. Weiss, HR., Klein, R.[2022]

A study involving 25 patients with idiopathic or degenerative scoliosis showed that practicing the side plank pose asymmetrically for an average of 6.8 months led to a significant reduction in the Cobb angle of the primary scoliotic curve by 32.0%.

Among the 19 patients who consistently practiced the pose, the improvement was even greater at 40.9%, indicating that this non-surgical technique may effectively strengthen muscles on the convex side of the curve and improve spinal alignment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serial case reporting yoga for idiopathic and degenerative scoliosis. Fishman, LM., Groessl, EJ., Sherman, KJ.[2020]

Both core stabilization exercises combined with bracing and the Scientific Exercises Approach to Scoliosis (SEAS) with bracing were effective in improving spinal curvature and trunk rotation in 30 females with moderate adolescent idiopathic scoliosis over a 4-month period.

While both treatment methods showed similar short-term benefits, only the core stabilization group reported improvements in pain, indicating a potential advantage in pain management with this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Core stabilization exercises versus scoliosis-specific exercises in moderate idiopathic scoliosis treatment. Yagci, G., Yakut, Y.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Isometric Yoga-Like Maneuvers Improve Adolescent Idiopathic Scoliosis-A Nonrandomized Control Trial. [2022]

2. Sweden pubmed.ncbi.nlm.nih.gov

Specific exercises reduce brace prescription in adolescent idiopathic scoliosis: a prospective controlled cohort study with worst-case analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effect of core-based exercise in people with scoliosis: A systematic review and meta-analysis. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Influence of an in-patient exercise program on scoliotic curve. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Short-Term 3-Dimensional Schroth Exercises In Adolescent Idiopathic Scoliosis: An Observational Study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Does exercise therapy improve pulmonary function in patients with Adolescent Idiopathic Scoliosis? [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of exercise therapy for the treatment of adolescent idiopathic scoliosis: a review of the literature. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

Actual evidence in the medical approach to adolescents with idiopathic scoliosis. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Acute muscle stretching and the ability to maintain posture in females with adolescent idiopathic scoliosis. [2019]

10. Spain pubmed.ncbi.nlm.nih.gov

[Preliminary study on the action of hypopressive gymnastics in the treatment of idiopathic scoliosis]. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Improving excellence in scoliosis rehabilitation: a controlled study of matched pairs. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Serial case reporting yoga for idiopathic and degenerative scoliosis. [2020]

13. France pubmed.ncbi.nlm.nih.gov

Core stabilization exercises versus scoliosis-specific exercises in moderate idiopathic scoliosis treatment. [2022]