Yoga for Scoliosis
(AIS Trial)
Recruiting in Palo Alto (17 mi)
Overseen byPaul Sponseller, MD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Non-AIS scoliosis, Surgery, Age, others
No Placebo Group
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.
12345Is 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.
15678How 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.
910111213Eligibility 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.
Trial 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
Participant Groups
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.
4Treatment groups
Active Control
Group I: Yoga BracedActive Control1 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 BracedActive Control1 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 careActive Control1 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 careActive Control1 Intervention
Patients who are not braced, will be randomized into a group that will continue with their standard of care current treatment
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins HospitalBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
References
Isometric Yoga-Like Maneuvers Improve Adolescent Idiopathic Scoliosis-A Nonrandomized Control Trial. [2022]Assess therapeutic value of specific yoga poses for thoracic and lumbar adolescent idiopathic scoliosis (AIS) taught in office or Internet.
Specific exercises reduce brace prescription in adolescent idiopathic scoliosis: a prospective controlled cohort study with worst-case analysis. [2022]To compare the effect of Scientific Exercises Approach to Scoliosis (SEAS) exercises with "usual care" rehabilitation programmes in terms of the avoidance of brace prescription and prevention of curve progression in adolescent idiopathic scoliosis.
Effect of core-based exercise in people with scoliosis: A systematic review and meta-analysis. [2022]To systematically assess the effectiveness of core-based exercise for correcting a spinal deformity and improving quality of life in people with scoliosis.
Influence of an in-patient exercise program on scoliotic curve. [2022]In 107 patients with idiopathic scoliosis radiographs were performed under standard conditions immediately before and immediately after a 4-6 week in-patient exercise program at the Katharina-Schroth Hospital. The average angle of curvature as measured by the Cobb technique was 43.06 degrees (standard deviation = 22.87) before treatment and 38.96 degrees (SD = 23.00) after treatment. An improvement in the curve of 5 degrees or more was found in 43.93% of the patients, 53.27% were unchanged and in 2.8% the curve increased by 5 degrees or more. Altogether the improvements in curvature were highly significant. These results show that even in severe scoliosis the magnitude of the curve can be reduced by a specific rehabilitation program of physiotherapy.
Effect of Short-Term 3-Dimensional Schroth Exercises In Adolescent Idiopathic Scoliosis: An Observational Study. [2022]The purpose of this study was to examine how a short-term Schroth exercise camp affects pain intensity, angle of trunk rotation (ATR), postural recovery, trunk muscle endurance, flexibility, dynamic balance, body image, perception of cosmetic deformity, and health-related quality of life in individuals with adolescent idiopathic scoliosis (AIS).
Does exercise therapy improve pulmonary function in patients with Adolescent Idiopathic Scoliosis? [2023]Exercise therapy is frequently used for treating patients with Adolescent Idiopathic Scoliosis (AIS) however no previous review has evaluated the effect of exercise therapy on pulmonary function in this population.
Efficacy of exercise therapy for the treatment of adolescent idiopathic scoliosis: a review of the literature. [2022]Current evidence regarding the use of exercise therapy in the treatment of adolescent idiopathic scoliosis (AIS) was assessed with a review of published literature.
Actual evidence in the medical approach to adolescents with idiopathic scoliosis. [2018]Idiopathic scoliosis (IS) is a three-dimensional deformity of the spine and trunk. The most common form involve adolescents. The prevalence is 2-3% of the population, with 1 out of 6 patients requiring treatment of which 25% progress to surgery. Physical and rehabilitation medicine (PRM) plays a primary role in the so-called conservative treatment of adolescents with IS, since all the therapeutic tools used (exercises and braces) fall into the PRM domain. According to a Cochrane systematic review there is evidence in favor of bracing, even if it is of low quality. Recently, a controlled prospective trial including a randomised arm gave more strength to this conclusion. Another Cochrane review shows that there is evidence in favor of exercises as an adjunctive treatment, but of low quality. Three meta-analysis have been published on bracing: one shows that bracing does not reduce surgery rates, but studies with bracing plus exercises were not included and had the highest effectiveness; another shows that full time is better than part-time bracing; the last focuses on observational studies following the Scoliosis Research Society (SRS) criteria and shows that not all full time rigid bracing are the same: some have the highest effectiveness, others have less than elastic and nighttime bracing. Two very important RCTs failed in recruitment, showing that in the field of bracing for scoliosis RCTs are not accepted by the patients. Consensuses by the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) show that there is no agreement among experts either on the best braces or on their biomechanical action, and that compliance is a matter of clinical more than patients' behavior (there is strong agreement on the management criteria to achieve best results with bracing). A systematic review of all the existing studies shows effectiveness of exercises, and that auto-correction is their main goal. A systematic review shows that there are no studies on manual treatment. The SOSORT Guidelines offer the actual standard of conservative care.
Acute muscle stretching and the ability to maintain posture in females with adolescent idiopathic scoliosis. [2019]Physiotherapy scoliosis specific exercises include exercises to attain and maintain proper posture, as well as flexibility movements such as stretching.
[Preliminary study on the action of hypopressive gymnastics in the treatment of idiopathic scoliosis]. [2022]Our goal is to describe the results of a hypopressive gymnastics (HG) program applied to 3 children with idiopathic scoliosis. Three children (ages ranging from 8 to 15 years) suffering from idiopathic scoliosis were recruited for this study. Thoracic or thoracolumbar curves showed between 15° and 40° Cobb degrees. The evolutionary character of the curves had been confirmed. A study of different clinical and radiological parameters was carried out to compare the measurements before and after (3 months later) the application of a 5 HG daily exercises programme: A radiological study of the spine was carried out to compare the measurements of the vertebral rotation. A radiological study, a plumb line and a measuring tape were used to assess the vertebral tilt in this study. A Scoliometer was used to measure the deformation of the rib cage (gibbosity). The most significant results were: a trend to reach stabilisation in the vertebral tilt and rotation, and stabilisation of gibbosity, which probably might improve the respiratory function of these subjects. Finally, the performance of an ordinary HG exercise program shows a trend to control and stabilise dorsal idiopathic scoliosis progression.
Improving excellence in scoliosis rehabilitation: a controlled study of matched pairs. [2022]Physiotherapy programmes so far mainly address the lateral deformity of scoliosis, a few aim at the correction of rotation and only very few address the sagittal profile. Meanwhile, there is evidence that correction forces applied in the sagittal plane are also able to correct the scoliotic deformity in the coronal and frontal planes. So it should be possible to improve excellence in scoliosis rehabilitation by the implementation of exercises to correct the sagittal deformity in scoliosis patients. An exercise programme (physio-logic exercises) aiming at a physiologic sagittal profile was developed to add to the programme applied at the centre or to replace certain exercises or exercising positions.
Serial case reporting yoga for idiopathic and degenerative scoliosis. [2020]Non-surgical techniques for treating scoliosis frequently focus on realigning the spine, typically by muscular relaxation or muscular or ligamentous stretching. However, such treatments, which include physical therapeutic, chiropractic, and bracing techniques, are inconsistently supported by current evidence. In this study, we assess the possible benefits of asymmetrical strengthening of truncal muscles on the convex side of the scoliotic curve through a single yoga pose, the side plank pose, in idiopathic and degenerative scoliosis.
Core stabilization exercises versus scoliosis-specific exercises in moderate idiopathic scoliosis treatment. [2022]There are several kinds of scoliosis-specific and general physiotherapeutic exercise methods used in scoliosis rehabilitation. But there is need for comparable studies on the effectiveness of different exercise approaches for the treatment of adolescent idiopathic scoliosis.