Scoliosis; AdolescenceNCT05259956
Trial on Two Treatments for Adolescent Idiopathic Scoliosis
A study testing Schroth based scoliosis specific exercise and "3 plus 1" multidimensional exercise therapy in people with Scoliosis; Adolescence, run by Peking University Aerospace Center Hospital at 1 site in China.
Trial summary
Adolescent Idiopathic scoliosis is a three-dimensional structural deformity of the spine and pelvic that occurs in children. More evidence has arisen to emphasize the important role played by pelvic asymmetry during the progression of scoliosis. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis; Adolescence
- What is being tested?
- Schroth based scoliosis specific exercise and "3 plus 1" multidimensional exercise therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2022to 7 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A diagnosis of adolescent idiopathic scoliosis; Age from 10 to 18 years; A Cobb angle of 10 to 25 degrees; All maturity levels (Risser sign of 0-5).
Who cannot join
- Non-idiopathic scoliosis, which is caused by a neuromuscular, neurological, congenital malformation, or trauma-related comorbidity; Having mental problems or other contraindications to exercise; Previous fractures, rheumatic diseases, or operation history of lower extremities; Previous or current brace or surgical treatments for scoliosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of "3+1" Multidimensional Therapeutic Exercises on the Progression of Adolescent Idiopathic Scoliosis
Adolescent Idiopathic scoliosis is a three-dimensional structural deformity of the spine and pelvic that occurs in children. More evidence has arisen to emphasize the important role played by pelvic asymmetry during the progression of scoliosis. The purpose of this study is to compare the effectiveness of pelvic adjustments accompanied with Schroth-based exercises, with the latter alone in adolescent idiopathic scoliosis, to assess the impact of pelvic asymmetry on the spinal three-dimensional parametric features in scoliosis.
Read the detailed description
Adolescent idiopathic scoliosis is the most common three-dimensional structural deformity of the spine among adolescence, the International Society on Scoliosis Orthopaedic and Rehabilitation Treatment recommend specific exercise therapy to delay the progression of scoliosis. Many specific exercise therapies are effective in reducing the angle of coronal scoliosis, but their efficiency in sagittal and axial deformities hasn't been convincing. Recent studies have found that the axial asymmetry of the pelvis may be involved in the pathogenesis of idiopathic scoliosis, but there is no clinical study on the treatment of scoliosis by correcting the axial torsion of the pelvis neither at home nor abroad. So in this study, "3 plus 1" multidimensional exercise therapy was applied to mild adolescent idiopathic scoliosis for the first time.
The present study is a single-center randomized controlled trial conducted at the department of rehabilitation medicine, Aerospace Center Hospital. The written Informed consent will be obtained from each patient and one of their parents before inclusion. Eligible subjects will be randomized by a 1:1 allocation ratio either to the experimental group, in which the "3 plus 1" multidimensional exercise therapy will be performed and pelvic correction technique was adopted to correct pelvic axial rotation, or the control group, in which they will receive the Schroth-based exercise therapy. Blinded assessments will be conducted at baseline and 6-month after the intervention, including the differences in three-dimensional structural parameters of pelvis and spine, such as the ratio of the iliac widths, SRS-22 questionnaire, etc, to compare the efficacy of two different groups in improving the three-dimensional balance of the spine and the quality of daily life in adolescent idiopathic scoliosis.
- Conditions
- Scoliosis; Adolescence
- Being tested
- Schroth based scoliosis specific exercise, "3 plus 1" multidimensional exercise therapy
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schroth based scoliosis specific exerciseBehavioural
The intervention is set to be delivered in a one-hour Schroth-based exercise session, with the frequency of twice a week for five weeks. The exercise consists of active auto-correction in 3D, stabilizing the corrected posture, and training in ADL.
"3 plus 1" multidimensional exercise therapyBehavioural
The intervention is set to be delivered in a 90-minute exercise session, with a frequency of twice a week for five weeks. The exercise consists of a one-hour Schroth-based exercise session and an additional 30-minute manipulative therapy of pelvic asymmetry.
| Study group | Role | What they receive |
|---|---|---|
| "3 plus 1" multidimensional exercise therapy | Experimental | The intervention consists of a Schroth-based exercise session and a manipulative therapy of pelvic asymmetry. Receives: Behavioral: "3 plus 1" multidimensional exercise therapy |
| Schroth based scoliosis specific exercise | Active comparator | The intervention consists of the Schroth-based exercise session. Receives: Behavioral: Schroth based scoliosis specific exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Ratio of Iliac Widths at 24th week
Rotation in the transverse plane of pelvic seen on a spinal standing full-length posteroanterior radiograph.
Measured: baseline and at 24th week
Secondary outcomes (6)
Change in Cobb Angle
The largest coronal convex curve is measured by the Cobb method on a spinal standing full-length posteroanterior radiograph.
Measured: baseline and at 24th week
Change in Apical Vertebral Translation in Main Curves
When an apical vertebra or disc is identified as the apex of the curve, the center of the vertebra or disc is identified by drawing a horizontal line through the vertebra or disc, apical translation of the disc is measured from the disc centroid to the center sacral vertical line (CSVL).
Measured: baseline and at 24th week
Change in Coronal Pelvic Tilt
The vertical distance between the horizontal tangents of the highest point of the bilateral iliac crest.
Measured: baseline and at 24th week
Change in Apical Vertebral Rotation in Main curves
The Nash and Moe method is used to determine vertebral rotation. The apical vertebral body is divided into six equal segments longitudinally. When both pedicles are in view, there is no vertebral rotation. It is graded as "0". When the pedicle in the concave side (the right side) starts disappearing, it is graded as "1". When the pedicle disappears, it is graded as "2". When the contralateral pedicle (pedicle in the convex side) is in the midline of the vertebra, it is graded as "3". When it crosses the midline of the vertebra, it is graded as "4".
Measured: baseline and at 24th week
Change in Angle of Trunk Rotation
The angle of trunk rotation will be measured with a Scoliometer.
Measured: baseline and at 24th week
Change in Scoliosis Research Society-22 Questionnaire
The SRS-22 contains 22 questions covering 5 domains: function/activity 5 items; pain 5 items; self-perceived image 5 items; mental health 5 items; and satisfaction with treatment 2 items. Each item is scored from 1 (worst) to 5 (best). The sum of the 5 domains is 110.
Measured: baseline and at 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start18 Feb 2022
- Primary completion7 Apr 2023
- Study completion7 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Aerospace Center Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Yafei, Peking University Aerospace Center Hospital
- Investigators
- Zhang Meng, Study director, Aerospace Centre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259956
- Sponsor's protocol ID
- HP2022-50-507005
- Status last verified
- Apr 2023
- First submitted
- 16 Feb 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of "3+1" Multidimensional Therapeutic Exercises on the Progression of Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05259956
- Acronym / sponsor ID
- HP2022-50-507005
- Conditions
- Scoliosis; Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Peking University Aerospace Center HospitalUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 7 Apr 2023 (actual)
- First posted
- 2 Mar 2022 (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.
Adolescent Idiopathic scoliosis is a three-dimensional structural deformity of the spine and pelvic that occurs in children. More evidence has arisen to emphasize the important role played by pelvic asymmetry during the progression of scoliosis. The purpose of this study is to compare the effectiveness of pelvic adjustments accompanied with Schroth-based exercises, with the latter alone in adolescent idiopathic scoliosis, to assess the impact of pelvic asymmetry on the spinal three-dimensional parametric features in scoliosis.
Detailed description
Adolescent idiopathic scoliosis is the most common three-dimensional structural deformity of the spine among adolescence, the International Society on Scoliosis Orthopaedic and Rehabilitation Treatment recommend specific exercise therapy to delay the progression of scoliosis. Many specific exercise therapies are effective in reducing the angle of coronal scoliosis, but their efficiency in sagittal and axial deformities hasn't been convincing. Recent studies have found that the axial asymmetry of the pelvis may be involved in the pathogenesis of idiopathic scoliosis, but there is no clinical study on the treatment of scoliosis by correcting the axial torsion of the pelvis neither at home nor abroad. So in this study, "3 plus 1" multidimensional exercise therapy was applied to mild adolescent idiopathic scoliosis for the first time.
The present study is a single-center randomized controlled trial conducted at the department of rehabilitation medicine, Aerospace Center Hospital. The written Informed consent will be obtained from each patient and one of their parents before inclusion. Eligible subjects will be randomized by a 1:1 allocation ratio either to the experimental group, in which the "3 plus 1" multidimensional exercise therapy will be performed and pelvic correction technique was adopted to correct pelvic axial rotation, or the control group, in which they will receive the Schroth-based exercise therapy. Blinded assessments will be conducted at baseline and 6-month after the intervention, including the differences in three-dimensional structural parameters of pelvis and spine, such as the ratio of the iliac widths, SRS-22 questionnaire, etc, to compare the efficacy of two different groups in improving the three-dimensional balance of the spine and the quality of daily life in adolescent idiopathic scoliosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "3 plus 1" multidimensional exercise therapy | Experimental | Behavioral: "3 plus 1" multidimensional exercise therapyThe intervention consists of a Schroth-based exercise session and a manipulative therapy of pelvic asymmetry. |
| Schroth based scoliosis specific exercise | Active comparator | Behavioral: Schroth based scoliosis specific exerciseThe intervention consists of the Schroth-based exercise session. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- A diagnosis of adolescent idiopathic scoliosis; Age from 10 to 18 years; A Cobb angle of 10 to 25 degrees; All maturity levels (Risser sign of 0-5).
Key exclusion criteria (1 listed)
- Non-idiopathic scoliosis, which is caused by a neuromuscular, neurological, congenital malformation, or trauma-related comorbidity; Having mental problems or other contraindications to exercise; Previous fractures, rheumatic diseases, or operation history of lower extremities; Previous or current brace or surgical treatments for scoliosis.
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 |
|---|---|---|
| Schroth based scoliosis specific exerciseThe intervention is set to be delivered in a one-hour Schroth-based exercise session, with the frequency of twice a week for five weeks. The exercise consists of active auto-correction in 3D, stabilizing the corrected posture, and training in ADL. | Behavioural | Schroth based scoliosis specific exercise |
| "3 plus 1" multidimensional exercise therapyThe intervention is set to be delivered in a 90-minute exercise session, with a frequency of twice a week for five weeks. The exercise consists of a one-hour Schroth-based exercise session and an additional 30-minute manipulative therapy of pelvic asymmetry. | Behavioural | "3 plus 1" multidimensional exercise therapy |
Primary outcome
Change From Baseline in Ratio of Iliac Widths at 24th week
Time frame: baseline and at 24th week
Rotation in the transverse plane of pelvic seen on a spinal standing full-length posteroanterior radiograph.
6 secondary outcomes
Change in Cobb Angle
Time frame: baseline and at 24th week
Change in Apical Vertebral Translation in Main Curves
Time frame: baseline and at 24th week
Change in Coronal Pelvic Tilt
Time frame: baseline and at 24th week
Change in Apical Vertebral Rotation in Main curves
Time frame: baseline and at 24th week
Change in Angle of Trunk Rotation
Time frame: baseline and at 24th week
Change in Scoliosis Research Society-22 Questionnaire
Time frame: baseline and at 24th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
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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. This study is not recruiting at the moment.
Zhang Meng study director
Aerospace Centre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schroth based scoliosis specific exercise and "3 plus 1" multidimensional exercise therapy in people with Scoliosis; Adolescence, run by Peking University Aerospace Center Hospital at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Apr 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Ratio of Iliac Widths at 24th week (time frame: baseline and at 24th week). 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 11 Apr 2023.