Scoliosis IdiopathicNCT03779581
Self Correction Exercises for Idiopathic Scoliosis Among Adolescents. A Randomised Controlled Trial
A study testing Self Correction exercises and orthotic devices in people with Scoliosis Idiopathic, run by Majmaah University at 1 site in Saudi Arabia.
Trial summary
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity with an unknown cause that affects adolescents aged 10 or older. A standing posterior-anterior radiograph with a Cobb angle greater than 10 degrees is used to make the diagnosis. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- Self Correction exercises and orthotic devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2018to 1 May 2022
- 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 16 years
- All sexes
- No healthy volunteers
- Child
10-16-year-olds with AIS, all sexes, all curve kinds, curves between 10° and 45°, Risser grade 0 to 5, with or without brace, and the capacity to attend weekly checkups.
Exclusion criteria included patients with a diagnosis other than AIS, those who had finished brace therapy, those planned for surgery, those with a follow-up scheduled beyond 62 months, and those who had had prior spine surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self Correction Exercises for Idiopathic Scoliosis Among Adolescents
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity with an unknown cause that affects adolescents aged 10 or older. A standing posterior-anterior radiograph with a Cobb angle greater than 10 degrees is used to make the diagnosis. Depending on the severity of the spinal deformity, conservative treatments and surgery are used to treat AIS. Patients whose spinal curvature is greater than 45 degrees are typically considered for surgery. The majority of patients with AIS receive conservative treatments to prevent and slow the progression of the curve. 2 Orthotic intervention (OI) and scoliosis-specific exercise (SSE) are commonly recommended by the International Society on Scoliosis Orthopaedic and Rehabilitation Treatment for patients with a curvature between 20 and 45 degrees. Self correction exercises are the group of spinal extension, lateral spinal flexion and rotational exercises performed to correct spinal deviation. Exercises are performed in a different fundamental postures.
Read the detailed description
Scoliosis is a malformation of the musculoskeletal system that is defined by lateral deviation of the spine, which is typically accompanied by vertebral rotation and lordosis. The term "scoliosis" refers to the curvature of the spine that results from the condition (3-dimensional deformity). Scoliosis in female teenagers often reaches its most advanced stage between the ages of 11 and 16 years old. In general, scoliosis may be broken down into two categories: structural and non-structural scoliosis. The level of severity and the degree of deformity of the spine are the major characteristics that differentiate the two groups. It is common practice to refer to the structural type of scoliosis as a sort of spinal deformity that cannot be corrected without surgical intervention. Bracing, exercises, and education are some of the conservative treatments that may be used to control non-structural spinal deformity, which is a movable disorder. Scoliosis that is not treated properly may advance to a functionally degraded condition, which is characterized by physical asymmetry, muscular imbalance, back discomfort, and considerable respiratory disruption. This can lead to distorted body image and a loss of self-esteem in the patient. Idiopathic adolescent scoliosis, more commonly known as AIS, is the diagnosis that is typically made in children who are otherwise healthy but have a spinal curvature of at least ten degrees but less than fifty degrees. This curvature range is what determines whether a child is considered to have AIS. While treating scoliosis, the primary goal of therapy should be to slow or stop the disease's development so that the treatment may be regarded effective. Non-conservative therapies often entail surgical techniques for the correction of spinal abnormalities; nevertheless, these operations do not come without associated risks. Individuals who arrive with a scoliosis curvature of less than 40 degrees have the potential to be candidates for conservative treatments such as physiotherapy scoliosis-specific exercise (PSSE), with or without the concomitant use of an external brace.
- Conditions
- Scoliosis Idiopathic
- Being tested
- Self Correction exercises, orthotic devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Correction exercisesOther
Active self-correction exercises to restore movements in different planes as close to physiologically normal as possible.
orthotic devicesDevice
the orthotic devices designed to correct the scoliosis curve
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | The experimental group received active self-correction exercises to restore movements in different planes as close as possible to physiologically normal. Receives: Other: Self Correction exercises |
| Control Group | Active comparator | All patients were prescribed a spinal orthosis (TLSO) and got a preliminary evaluation for orthosis design and manufacturing based on the curve type categorization from Ross and Weiss during the first appointment (Rigo et al., 2010). Receives: Device: orthotic devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angle
Angulation calculated on X-ray
Measured: 1-2 hours
SRS 22
Scoliosis rating scale 22 items
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jan 2018
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies 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
- Model description
- 1431 of the 108 subjects visiting out-patient Department of our hospital met the inclusion criteria. All the subjects diagnosed with kyphoscoliosis signed the informed consent approved by the ethical committee of the hospital. The diagnosis was based on the diagnosis by an experienced radiologist. Subjects with idiopathic kyphoscoliosis and Cobb's angle greater than 60 degree and normal pulmonary function were included. The subjects with other cardiovascular pathologies, congenital disorders and inability to commute were excluded from this study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Majmaah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, faizan kashoo, PT, Majmaah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779581
- Sponsor's protocol ID
- MajmaahUniversity
- Status last verified
- Feb 2023
- First submitted
- 17 Dec 2018
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Correction Exercises for Idiopathic Scoliosis Among Adolescents
- ClinicalTrials.gov ID
- NCT03779581
- Acronym / sponsor ID
- MajmaahUniversity
- Conditions
- Scoliosis Idiopathic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Majmaah UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 19 Dec 2018 (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 a three-dimensional spinal deformity with an unknown cause that affects adolescents aged 10 or older. A standing posterior-anterior radiograph with a Cobb angle greater than 10 degrees is used to make the diagnosis. Depending on the severity of the spinal deformity, conservative treatments and surgery are used to treat AIS. Patients whose spinal curvature is greater than 45 degrees are typically considered for surgery. The majority of patients with AIS receive conservative treatments to prevent and slow the progression of the curve. 2 Orthotic intervention (OI) and scoliosis-specific exercise (SSE) are commonly recommended by the International Society on Scoliosis Orthopaedic and Rehabilitation Treatment for patients with a curvature between 20 and 45 degrees. Self correction exercises are the group of spinal extension, lateral spinal flexion and rotational exercises performed to correct spinal deviation. Exercises are performed in a different fundamental postures.
Detailed description
Scoliosis is a malformation of the musculoskeletal system that is defined by lateral deviation of the spine, which is typically accompanied by vertebral rotation and lordosis. The term "scoliosis" refers to the curvature of the spine that results from the condition (3-dimensional deformity). Scoliosis in female teenagers often reaches its most advanced stage between the ages of 11 and 16 years old. In general, scoliosis may be broken down into two categories: structural and non-structural scoliosis. The level of severity and the degree of deformity of the spine are the major characteristics that differentiate the two groups. It is common practice to refer to the structural type of scoliosis as a sort of spinal deformity that cannot be corrected without surgical intervention. Bracing, exercises, and education are some of the conservative treatments that may be used to control non-structural spinal deformity, which is a movable disorder. Scoliosis that is not treated properly may advance to a functionally degraded condition, which is characterized by physical asymmetry, muscular imbalance, back discomfort, and considerable respiratory disruption. This can lead to distorted body image and a loss of self-esteem in the patient. Idiopathic adolescent scoliosis, more commonly known as AIS, is the diagnosis that is typically made in children who are otherwise healthy but have a spinal curvature of at least ten degrees but less than fifty degrees. This curvature range is what determines whether a child is considered to have AIS. While treating scoliosis, the primary goal of therapy should be to slow or stop the disease's development so that the treatment may be regarded effective. Non-conservative therapies often entail surgical techniques for the correction of spinal abnormalities; nevertheless, these operations do not come without associated risks. Individuals who arrive with a scoliosis curvature of less than 40 degrees have the potential to be candidates for conservative treatments such as physiotherapy scoliosis-specific exercise (PSSE), with or without the concomitant use of an external brace.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1431 of the 108 subjects visiting out-patient Department of our hospital met the inclusion criteria. All the subjects diagnosed with kyphoscoliosis signed the informed consent approved by the ethical committee of the hospital. The diagnosis was based on the diagnosis by an experienced radiologist. Subjects with idiopathic kyphoscoliosis and Cobb's angle greater than 60 degree and normal pulmonary function were included. The subjects with other cardiovascular pathologies, congenital disorders and inability to commute were excluded from this study.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Self Correction exercisesThe experimental group received active self-correction exercises to restore movements in different planes as close as possible to physiologically normal. |
| Control Group | Active comparator | Device: orthotic devicesAll patients were prescribed a spinal orthosis (TLSO) and got a preliminary evaluation for orthosis design and manufacturing based on the curve type categorization from Ross and Weiss during the first appointment (Rigo et al., 2010). |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Self Correction exercisesActive self-correction exercises to restore movements in different planes as close to physiologically normal as possible. | Other | Exercise Group |
| orthotic devicesthe orthotic devices designed to correct the scoliosis curve | Device | Control Group |
Primary outcome
Cobb angle
Time frame: 1-2 hours
Angulation calculated on X-ray
SRS 22
Time frame: 1-2 hours
Scoliosis rating scale 22 items
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 1 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Correction exercises and orthotic devices in people with Scoliosis Idiopathic, run by Majmaah University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Mar 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 Saudi Arabia. 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?
Cobb angle (time frame: 1-2 hours). 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 1 Mar 2023.