Adolescent Idiopathic ScoliosisNCT06672029
Long-term Effectiveness of Integrative Scoliosis-specific Rehabilitation in High-risk Adolescent Idiopathic Scoliosis
A study testing combining pattern-specific manual therapy, Schroth Best Practice exercise, and Gensingen brace application in people with Adolescent Idiopathic Scoliosis, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
Adolescent idiopathic scoliosis (AIS) is one of the most common spinal deformities diagnosed in adolescents, especially female, with the prevalence in general population ranging from 0.93% to 12%, 80% of which are idiopathic. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- combining pattern-specific manual therapy, Schroth Best Practice exercise, and Gensingen brace application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jan 2021to 14 Aug 2024
- 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
- 1) fulfill a diagnosis of AIS;
- 2) age between 10 and 18 years old;
- 3) Cobb angle ≧ 20˚;
- 4) incidence of progression over 60% according to Lonstein et al. ;
- 5) never underwent treatment that might affect scoliosis;
- 6) complete follow-ups of at least 12 months after the end of treatment.
Who cannot join
- 1) A diagnosis of non-idiopathic scoliosis (e.g. secondary or functional scoliosis);
- 2) any psychological problems;
- 3) pregnancy;
- 4) any severe rheumatic or chronic neuromuscular diseases (e.g. rheumatoid arthritis, ankylosing spondylitis);
- 5) any severe orthopedic problems (e.g. bone tumor, fracture);
- 6) refusal of the suggested treatment;
- 7) any previous or ongoing treatment of scoliosis;
- 8) any contraindications to brace, exercise, or manipulative treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Adolescent idiopathic scoliosis (AIS) is one of the most common spinal deformities diagnosed in adolescents, especially female, with the prevalence in general population ranging from 0.93% to 12%, 80% of which are idiopathic. The management and treatment of AIS includes observation, physiotherapy (or therapeutic exercise), brace application, and surgery. Evidence of the conservative management of AIS has been stronger in recent years. However, the best combination therapy has not been well established. Moreover, the investigator has demonstrated an innovation of pattern-specific manual therapy to treat AIS. Different from previous conservative treatment, the investigators applied specific treatment for different patterns of AIS according to the Lehnert-Schroth (LS) scoliosis classification. Therefore, the investigators aim to determinate the long-term effects of the integrative scoliosis-specific rehabilitation program combining pattern-specific manual therapy, Schroth Best Practice (SBP) exercise, and Gensingen brace application in treating AIS patients.
Read the detailed description
Adolescent idiopathic scoliosis (AIS) is one of the most common spinal deformities diagnosed in adolescents, especially female, with the prevalence in general population ranging from 0.93% to 12%, 80% of which are idiopathic. It is a complex 3D structural disorder, diagnosed when the Cobb angle is equal to or greater than 10 degrees, accompanied by vertebral rotation. The risk factors of curve progression include growth spurt, positive family history, laxity of skin and joints, flat back, and angle of trunk rotation more than 10 degrees. Curve progression can lead to aesthetic concerns, spinal pain syndromes, and respiratory dysfunction.
The management and treatment of AIS includes observation, physiotherapy (or therapeutic exercise), brace application, and surgery. According to Lonstein et al, a progression factor, which is used for the risk assessment of curve progression of progression, is calculated using the Risser sign, age at presentation, and magnitude of the curve. A probability for progression of under 40% is indicated for observation only, while the probability for progression of 40% - 60% is indicated for physiotherapy, and the probability for progression of over 60% is considered indicated for bracing application. Current evidence recommended that bracing be applied in evolutive AIS patients (Risser 0 to 3) with curves above 20° ± 5° Cobb.
Current studies have investigated the efficacy of conservative treatment for AIS. In terms of bracing, previous studies have shown that AIS patients treated with Rigo Chêneau orthoses had lower major curve progression versus those with Boston-style orthoses. Furthermore, the Gensingen brace is developed from Chêneau brace with individual computer-aided design, which exhibits efficacy in decreasing Cobb angle and angle of trunk rotation. There are a wide range of physiotherapeutic scoliosis-specific exercise methods, among which the Schroth exercise program is the mostly studied and is proven to be effective. The Schroth method consists of postural, sensorimotor, and corrective breathing exercises in daily activities for three-dimensional correction of the patients' specific curve patterns.
A randomized-controlled study in 2016 revealed that Schroth exercise program was superior to home exercise and control groups in decreasing the Cobb and rotation angles. In addition, a randomized-controlled study in 2016 revealed that adding Schroth physiotherapeutic scoliosis-specific exercises to standard care of bracing can lead to better reduction of curve severity than bracing alone in treating AIS patients. Also, long-term improvement of combining Schroth exercise and Chêneau orthoses has been observed. On the other hand, manual therapy in treating AIS is less studied, and current evidence is insufficient to confirm the benefit of manual therapy in AIS patients. This study applied a pattern-specific manual therapy to mobilize and realign the asymmetry of the spine and extra-spinal regions.
Evidence of the conservative management of AIS has been stronger in recent years. However, the best combination therapy has not been well established. Moreover, the investigator has demonstrated an innovation of pattern-specific manual therapy, to treat AIS. Different from previous conservative treatment, the investigators applied specific treatment for different patterns of AIS according to the Lehnert-Schroth (LS) scoliosis classification. Therefore, the investigators aim to determinate the long-term effects of the integrative scoliosis-specific rehabilitation program combining pattern-specific manual therapy, Schroth Best Practice exercise, and Gensingen brace application in treating AIS patients.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- combining pattern-specific manual therapy, Schroth Best Practice exercise, and Gensingen brace application
- Keywords
- adolescent idiopathic scoliosis, manual therapy, Schroth Best Practice, Gensingen brace, scoliosis-specific rehabilitation program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combining pattern-specific manual therapy, Schroth Best Practice exercise, and Gensingen brace applicationOther
- The pattern-specific manual therapy: It was developed by our author. This therapy was done immediately before each SBP (Schroth Best Practice) exercise session, targeting both the spine and extra-spinal regions.
- The Schroth Best Practice exercises: It contains following 6 components: The physio-logic® program for sagittal profile correction, education on activities of daily living (ADLs), the "3D made easy" program, the new "Power Schroth" program, the rehabilitation of walk, and neuromobilization.
- The Gensingen brace application: it was made according to the patients' Lehnert Schroth Classifications. the investigators recommended the patients to wear the brace for 21-23 hours per day during the first year. As the bone maturation reached Risser 4 to 4.5, the daily brace wearing time was gradually reduced.
| Study group | Role | What they receive |
|---|---|---|
| Patients with adolescent idiopathic scoliosis | Experimental | All patients receive a combination of therapy including the three listed below:
* The pattern-specific manual therapy
* The Schroth Best Practice exercises
* The Gensingen brace application Receives: Other: combining pattern-specific manual therapy, Schroth Best Practice exercise, and Gensingen brace application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle of trunk rotation (ATR)
The ATR was measured with a Scoliometer™ in a forward bending posture. It is defined as the angle between the horizontal plane and the plane across the posterior aspect of the back, and the minimal clinically important difference (MCID) is 5 degrees.
Measured: measured at the baseline, end of the treatment course (about half an year), and a year after the treatment course
Cobb angle
The Cobb angles of major curves were measured via standing posteroanterior radiograph. Based on the consensus of SOSORT and SRS non-operative management committee, radiographic definitions of improvement is 6 degrees or more.
Measured: measured at the baseline, end of the treatment course (about half an year), and a year after the treatment course
Secondary outcomes (1)
lateral deviation
Lateral deviation, which may affect trunk balance, is measured by the distance between transitional point (TP) and central sacral line via posteroanterior whole spine radiograph. It was measured only for those with TP deviation more than 2 cm.
Measured: measured at the baseline, end of the treatment course (about half an year), and a year after the treatment course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start5 Jan 2021
- Primary completion31 Dec 2022
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- retrospective study
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin-Fen Hsieh, Shin Kong Wu Ho-Su Memorial Hospital
- Investigators
- Lin-Fen Hsieh, M.D., Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672029
- Sponsor's protocol ID
- 20241003R
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effectiveness of Integrative Scoliosis-specific Rehabilitation in High-risk Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06672029
- Acronym / sponsor ID
- 20241003R
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- adolescent idiopathic scoliosis, manual therapy, Schroth Best Practice, Gensingen brace, scoliosis-specific rehabilitation program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 4 Nov 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.
Adolescent idiopathic scoliosis (AIS) is one of the most common spinal deformities diagnosed in adolescents, especially female, with the prevalence in general population ranging from 0.93% to 12%, 80% of which are idiopathic. The management and treatment of AIS includes observation, physiotherapy (or therapeutic exercise), brace application, and surgery. Evidence of the conservative management of AIS has been stronger in recent years. However, the best combination therapy has not been well established. Moreover, the investigator has demonstrated an innovation of pattern-specific manual therapy to treat AIS. Different from previous conservative treatment, the investigators applied specific treatment for different patterns of AIS according to the Lehnert-Schroth (LS) scoliosis classification. Therefore, the investigators aim to determinate the long-term effects of the integrative scoliosis-specific rehabilitation program combining pattern-specific manual therapy, Schroth Best Practice (SBP) exercise, and Gensingen brace application in treating AIS patients.
Detailed description
Adolescent idiopathic scoliosis (AIS) is one of the most common spinal deformities diagnosed in adolescents, especially female, with the prevalence in general population ranging from 0.93% to 12%, 80% of which are idiopathic. It is a complex 3D structural disorder, diagnosed when the Cobb angle is equal to or greater than 10 degrees, accompanied by vertebral rotation. The risk factors of curve progression include growth spurt, positive family history, laxity of skin and joints, flat back, and angle of trunk rotation more than 10 degrees. Curve progression can lead to aesthetic concerns, spinal pain syndromes, and respiratory dysfunction.
The management and treatment of AIS includes observation, physiotherapy (or therapeutic exercise), brace application, and surgery. According to Lonstein et al, a progression factor, which is used for the risk assessment of curve progression of progression, is calculated using the Risser sign, age at presentation, and magnitude of the curve. A probability for progression of under 40% is indicated for observation only, while the probability for progression of 40% - 60% is indicated for physiotherapy, and the probability for progression of over 60% is considered indicated for bracing application. Current evidence recommended that bracing be applied in evolutive AIS patients (Risser 0 to 3) with curves above 20° ± 5° Cobb.
Current studies have investigated the efficacy of conservative treatment for AIS. In terms of bracing, previous studies have shown that AIS patients treated with Rigo Chêneau orthoses had lower major curve progression versus those with Boston-style orthoses. Furthermore, the Gensingen brace is developed from Chêneau brace with individual computer-aided design, which exhibits efficacy in decreasing Cobb angle and angle of trunk rotation. There are a wide range of physiotherapeutic scoliosis-specific exercise methods, among which the Schroth exercise program is the mostly studied and is proven to be effective. The Schroth method consists of postural, sensorimotor, and corrective breathing exercises in daily activities for three-dimensional correction of the patients' specific curve patterns.
A randomized-controlled study in 2016 revealed that Schroth exercise program was superior to home exercise and control groups in decreasing the Cobb and rotation angles. In addition, a randomized-controlled study in 2016 revealed that adding Schroth physiotherapeutic scoliosis-specific exercises to standard care of bracing can lead to better reduction of curve severity than bracing alone in treating AIS patients. Also, long-term improvement of combining Schroth exercise and Chêneau orthoses has been observed. On the other hand, manual therapy in treating AIS is less studied, and current evidence is insufficient to confirm the benefit of manual therapy in AIS patients. This study applied a pattern-specific manual therapy to mobilize and realign the asymmetry of the spine and extra-spinal regions.
Evidence of the conservative management of AIS has been stronger in recent years. However, the best combination therapy has not been well established. Moreover, the investigator has demonstrated an innovation of pattern-specific manual therapy, to treat AIS. Different from previous conservative treatment, the investigators applied specific treatment for different patterns of AIS according to the Lehnert-Schroth (LS) scoliosis classification. Therefore, the investigators aim to determinate the long-term effects of the integrative scoliosis-specific rehabilitation program combining pattern-specific manual therapy, Schroth Best Practice exercise, and Gensingen brace application in treating AIS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- retrospective study
| Arm | Type | Receives |
|---|---|---|
| Patients with adolescent idiopathic scoliosis | Experimental | Other: combining pattern-specific manual therapy, Schroth Best Practice exercise, and Gensingen brace applicationAll patients receive a combination of therapy including the three listed below: * The pattern-specific manual therapy * The Schroth Best Practice exercises * The Gensingen brace application |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 1) fulfill a diagnosis of AIS;
- 2) age between 10 and 18 years old;
- 3) Cobb angle ≧ 20˚;
- 4) incidence of progression over 60% according to Lonstein et al. ;
- 5) never underwent treatment that might affect scoliosis;
Key exclusion criteria (8 listed)
- 1) A diagnosis of non-idiopathic scoliosis (e.g. secondary or functional scoliosis);
- 2) any psychological problems;
- 3) pregnancy;
- 4) any severe rheumatic or chronic neuromuscular diseases (e.g. rheumatoid arthritis, ankylosing spondylitis);
- 5) any severe orthopedic problems (e.g. bone tumor, fracture);
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 |
|---|---|---|
| combining pattern-specific manual therapy, Schroth Best Practice exercise, and Gensingen brace application* The pattern-specific manual therapy: It was developed by our author. This therapy was done immediately before each SBP (Schroth Best Practice) exercise session, targeting both the spine and extra-spinal regions. * The Schroth Best Practice exercises: It contains following 6 components: The physio-logic® program for sagittal profile correction, education on activities of daily living (ADLs), the "3D made easy" program, the new "Power Schroth" program, the rehabilitation of walk, and neuromobilization. * The Gensingen brace application: it was made according to the patients' Lehnert Schroth Classifications. the investigators recommended the patients to wear the brace for 21-23 hours per day during the first year. As the bone maturation reached Risser 4 to 4.5, the daily brace wearing time was gradually reduced. | Other | Patients with adolescent idiopathic scoliosis |
Primary outcome
Angle of trunk rotation (ATR)
Time frame: measured at the baseline, end of the treatment course (about half an year), and a year after the treatment course
The ATR was measured with a Scoliometer™ in a forward bending posture. It is defined as the angle between the horizontal plane and the plane across the posterior aspect of the back, and the minimal clinically important difference (MCID) is 5 degrees.
Cobb angle
Time frame: measured at the baseline, end of the treatment course (about half an year), and a year after the treatment course
The Cobb angles of major curves were measured via standing posteroanterior radiograph. Based on the consensus of SOSORT and SRS non-operative management committee, radiographic definitions of improvement is 6 degrees or more.
1 secondary outcome
lateral deviation
Time frame: measured at the baseline, end of the treatment course (about half an year), and a year after the treatment course
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 4 Nov 2024.
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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.
Lin-Fen Hsieh, M.D. principal investigator
Shin Kong Wu Ho-Su Memorial 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 combining pattern-specific manual therapy, Schroth Best Practice exercise, and Gensingen brace application in people with Adolescent Idiopathic Scoliosis, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
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 6 inclusion and 8 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 4 Nov 2024. 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 Taiwan. 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?
Angle of trunk rotation (ATR) (time frame: measured at the baseline, end of the treatment course (about half an year), and a year after the treatment course). 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 4 Nov 2024.