Scoliosis Idiopathic Adolescent TreatmentAISNCT06242821
Yoga for Back Pain in Adolescent Scoliosis
A study testing Yoga in people with Scoliosis Idiopathic Adolescent Treatment and Scoliosis Idiopathic, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Scoliosis Idiopathic Adolescent Treatment, Scoliosis Idiopathic, Scoliosis; Adolescence
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21230
Alexandra Seidenstein, MD, PhD, 443-997-5437, aseiden8@jh.edu
Gabrielle Reichard, MS, 443-997-5437, greicha1@jhmi.edu
About this study
Official title: Back Pain Management in AIS: Impact of Yoga as Adjunct Treatment
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.
Read more
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.
- 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.
Read the detailed description
Scoliosis, the most prevalent spinal pathology in children and adolescents, is characterized by a coronal plane spinal curvature more than 10 degrees. Adolescent Idiopathic Scoliosis (AIS) is estimated to impact upwards of 5% of the population with a 3:1 female to male ratio. Treatment options are dictated by curve magnitude and future growth potential. Observation, bracing, supportive physical therapy may be recommended. Research has consistently demonstrated an increasing prevalence of low back pain (LBP) in both children and adolescents over the last few decades. Recent meta-analysis showed that amongst adolescence with LBP, scoliosis is the highest associated abnormality. In addition, biopsychosocial factors are also highly associated with the presence of back pain amongst the AIS population. AIS has been shown to be significantly associated with decreased sleep quality, and depression that is coupled with chronic and/or episodic LBP. This research suggests that patients with AIS should have a psychosocial profile in addition to curve magnitude, and LBP level monitoring.
According to the National Health Interview Survey, 20% of alternative health practitioners state that the practitioners participate in yoga classes for general back pain. The popularity of yoga in the US has increased to an estimated 35 million in 2017, and has become the most utilized complementary health approach. Results of these studies support not only physiological improvement in flexibility, relaxation, and body awareness, but also reduces oxidative stress and inflammation, increases release of neurotransmitters, anxiety and increases pain tolerance resulting in psychological improvement as well. The investigator's study will utilize a well-define a twenty-minute yoga protocol that will be added to some patients undergoing symptomatic non-operative scoliosis treatment. The investigators will measure the angle to see if there is change, the investigator's primary focus will be on reduction of back pain in AIS.
This study consists of a randomized clinical trial with non-operative AIS patients at Johns Hopkins Hospital. The trial will consist of two branches of non-operative AIS patients: 1. Patients that brace, 2. Patients who do not brace. This allocation will be achieved through random assignment to either the patient's standard of care as prescribed with or without the addition of yoga.
- Conditions
- Scoliosis Idiopathic Adolescent Treatment, Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis
- Being tested
- Standard of Care (SOC), Yoga
- Keywords
- Adolescent Idiopathic Scoliosis, yoga
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SOC)Other
Patients will continue with their current standard of care treatment.
YogaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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, Receives: 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 Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Enrollment, 6 months, 1 year
Secondary outcomes (1)
Cobb Angle measurement
Patients will have cobb angle (extent of scoliotic curve) measured
Measured: Enrollment, 6 months, 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis Idiopathic Adolescent TreatmentStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Sponseller, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242821
- Sponsor's protocol ID
- IRB00423950
- Acronym
- AIS
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back Pain Management in AIS: Impact of Yoga as Adjunct Treatment
- ClinicalTrials.gov ID
- NCT06242821
- Acronym / sponsor ID
- AIS / IRB00423950
- Conditions
- Scoliosis Idiopathic Adolescent Treatment, Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, yoga
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Detailed description
Scoliosis, the most prevalent spinal pathology in children and adolescents, is characterized by a coronal plane spinal curvature more than 10 degrees. Adolescent Idiopathic Scoliosis (AIS) is estimated to impact upwards of 5% of the population with a 3:1 female to male ratio. Treatment options are dictated by curve magnitude and future growth potential. Observation, bracing, supportive physical therapy may be recommended. Research has consistently demonstrated an increasing prevalence of low back pain (LBP) in both children and adolescents over the last few decades. Recent meta-analysis showed that amongst adolescence with LBP, scoliosis is the highest associated abnormality. In addition, biopsychosocial factors are also highly associated with the presence of back pain amongst the AIS population. AIS has been shown to be significantly associated with decreased sleep quality, and depression that is coupled with chronic and/or episodic LBP. This research suggests that patients with AIS should have a psychosocial profile in addition to curve magnitude, and LBP level monitoring.
According to the National Health Interview Survey, 20% of alternative health practitioners state that the practitioners participate in yoga classes for general back pain. The popularity of yoga in the US has increased to an estimated 35 million in 2017, and has become the most utilized complementary health approach. Results of these studies support not only physiological improvement in flexibility, relaxation, and body awareness, but also reduces oxidative stress and inflammation, increases release of neurotransmitters, anxiety and increases pain tolerance resulting in psychological improvement as well. The investigator's study will utilize a well-define a twenty-minute yoga protocol that will be added to some patients undergoing symptomatic non-operative scoliosis treatment. The investigators will measure the angle to see if there is change, the investigator's primary focus will be on reduction of back pain in AIS.
This study consists of a randomized clinical trial with non-operative AIS patients at Johns Hopkins Hospital. The trial will consist of two branches of non-operative AIS patients: 1. Patients that brace, 2. Patients who do not brace. This allocation will be achieved through random assignment to either the patient's standard of care as prescribed with or without the addition of yoga.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Yoga Braced | Active comparator | Other: YogaPatients, 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 |
| Yoga - Not Braced | Active comparator | Other: YogaPatients, 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 |
| Braced - Standard of care | Active comparator | Other: Standard of Care (SOC)Patients who are braced, will be randomized into a group that will continue with their standard of care current treatment, |
| Non Braced - Standard of care | Active comparator | Other: Standard of Care (SOC)Patients who are not braced, will be randomized into a group that will continue with their standard of care current treatment |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care (SOC)Patients will continue with their current standard of care treatment. | Other | Braced - Standard of care, Non Braced - Standard of care |
| YogaPatients 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. | Other | Yoga - Not Braced, Yoga Braced |
Primary outcome
Pain and Quality of Life as assessed by the Scoliosis Research Society (SRS-22) questionnaire
Time frame: Enrollment, 6 months, 1 year
Possible score range from 0 (no pain)to 5(worst possible pain). A higher score indicates a better quality of life.
Participant Engagement
Time frame: Enrollment, 6 months, 1 year
Participant engagement will be measured by comparing attendance and adherence rates between the two groups to assess patient engagement with each intervention.
1 secondary outcome
Cobb Angle measurement
Time frame: Enrollment, 6 months, 1 yr
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Quality of Life, Psychosocial Burden, and Structural-functional Status in Adults With Spinal Deformity.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Sponseller, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Scoliosis Idiopathic Adolescent Treatment and Scoliosis Idiopathic, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra H Seidenstein, MD (410-502-3626, aseiden8@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and Quality of Life as assessed by the Scoliosis Research Society (SRS-22) questionnaire (time frame: Enrollment, 6 months, 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.