Adolescent Idiopathic ScoliosisNCT05765019
Investigation of the Efficiency of Spinal Mobilization in Patients With Adolescent Idiopathic Scoliosis
A study testing Spinal mobilization and Core stabilization exercise in people with Adolescent Idiopathic Scoliosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to evaluate the effect of spinal mobilization techniques applied in addition to core stabilization exercises in Adolescent Idiopathic Scoliosis (AIS) patients. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Spinal mobilization and Core stabilization exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2023to 5 Nov 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients diagnosed with AIS
- Age 10-16 years
- Cobb angle was between 10° and 25
- Risser sing did not exceed 4
- Informed consent forms were signed by the parents and children
Who cannot join
- Used brace,
- Had previous spinal surgery, inferior limb length difference,
- Could not exercise due to another injury/diagnosis,
- Had neuromuscular, psychiatric, cardiovascular, respiratory insufficiency and mental disability
Trial locations and contacts
1 site in 1 country.
About this study
In this study, it was aimed to evaluate the effect of spinal mobilization techniques applied in addition to core stabilization exercises in Adolescent Idiopathic Scoliosis (AIS) patients.
Consecutive adolescents with idiopathic scoliosis, aged 10 to 16 years, without a brace, and with a Cobb curvature of 10 to 25 degrees were randomly divided into two groups using the closed envelope method: Spinal mobilization and core stabilization exercise were applied to the experimental group; Only core stabilization exercises were applied to the control group.
Both groups received interventions twice a week for 10 weeks. Outcome measurements were made before treatment and after 10 weeks of treatment.
Read the detailed description
This study was a randomized controlled trial in which participants and assessor were blinded. This study was carried out in Amasya University Ruhi Tingiz Physical Therapy and Rehabilitation Hospital Rehabilitation Unit between August 2022 and January 2023. Ethics committee approval was obtained from Amasya University (E-76988455-050.01.04-83314) on 05.08.2022 to conduct the study. Before the study, face-to-face interviews were conducted with the all participants and parents and informed about the subject and purpose of the study. Verbal and written consent was obtained from the all participants and parents.
Sample size: The sample of the study was calculated with the G*Power 3.1 program, and the effect size (d=1.0) was calculated according to the double-tailed hypothesis method, taking into account the study. (d=1.0; α=0.05; 1-ß=0.80). Confidence interval was determined as 80% and margin of error was 5% (α=0.05). As a result of the calculation, it was determined that there should be 17 adolescent scoliosis patients for the control group, 17 for the experimental group, and a total of 34 adolescent scoliosis patients. Considering the possible data losses of the participants, we planned to include a total of 40 participants, 20 in both groups.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Spinal mobilization, Core stabilization exercise
- Keywords
- Adolescent idiopathic scoliosis, Core stabilization exercises, Spinal mobilization, Manual therapy, Pulmonary function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal mobilizationOther
Spinal mobilization and core stabilization exercise
Core stabilization exerciseOther
Stabilization exercises for the spine
| Study group | Role | What they receive |
|---|---|---|
| Spinal mobilization group | Experimental | Not described Receives: Other: Spinal mobilization; Other: Core stabilization exercise |
| Core stabilization exercise group | Active comparator | Not described Receives: Other: Core stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angle
The most accepted way of scoliosis evaluation is Cobb angle measurement performed on frontal plane x-ray. The Cobb angle is the curvature of the spine, and measuring it is essential for determining the severity of scoliosis, selecting the best course of action, and monitoring the progression or regression of cases following treatment. The Cobb angle measure as the vertically intersecting angle after determining the vertebrae above the apex and below the apex, which are the most tilted from the concave side of the curvature of the spine.
Measured: Change from pretreatment and 10 weeks after treatment.
Secondary outcomes (7)
Angle of Trunk Rotation
It assessed with a Bunnell scoliometer is a type of inclinometer that measures the asymmetry of the degree of axial rotation on both sides of the body. Assessment is in a standing, forward-bending position bent-over position (arms dangling, palms pressed together) with the pelvis horizontal, and subject standing on a foot template
Measured: Change from pretreatment and 10 weeks after treatment.
Pulmonary Functions Test- PEF (Peak expiratory flow)
Peak expiratory flow (PEF) is the volume of air forcefully expelled from the lungs in one quick exhalation, and is a reliable indicator of ventilation adequacy as well as airflow obstruction.
Measured: Change from pretreatment and 10 weeks after treatment.
Pulmonary Functions Test- FEV1 (Forced expiratory volume in the first second)
The forced expiratory volume in 1 second (FEV1) is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration
Measured: Change from pretreatment and 10 weeks after treatment.
Pulmonary Functions Test-FVC (Forced vital capacity)
Forced vital capacity, the maximum amount of air you can forcibly exhale from your lungs after fully inhaling.
Measured: Change from pretreatment and 10 weeks after treatment.
Pulmonary Functions Test- FEV1/FVC
The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs.
Measured: Change from pretreatment and 10 weeks after treatment.
Walter Reed Visual Assessment Scale
It was designed to measure physical deformity as perceived by patients with idiopathic scoliosis. The scale assesses seven aspects of the deformity: spinal curvature, rib prominence, flank prominence, deformity/alignment of the thorax with respect to the pelvis, trunk imbalance, shoulder asymmetry and scapular asymmetry. Scores for each catagory range from 1 (no deformity) to 5 (the worst deformity), and the total score is generated from the sum of the scores from the seven domains.
Measured: Change from pretreatment and 10 weeks after treatment.
Scoliosis Research Society-22
Scale is a simple and practical quality of life questionnaire specially created for individuals with scoliosis. SRS includes parameters such as pain, self-image/appearance, function/activity, mental health, and satisfaction with treatment. It is also stated that it is effective in evaluating the changes that occur with treatment. The questionnaire has a total of 22 items that are scored from 1 (worst) to 5 (best) for each item.
Measured: Change from pretreatment and 10 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start25 Feb 2023
- Primary completion15 Oct 2023
- Study completion5 Nov 2023
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.
- More trials run by Hacettepe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylem KÜÇÜK, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765019
- Sponsor's protocol ID
- HacettepeUE
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2023
- Last updated
- 5 Mar 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficiency of Spinal Mobilization in Patients With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05765019
- Acronym / sponsor ID
- HacettepeUE
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent idiopathic scoliosis, Core stabilization exercises, Spinal mobilization, Manual therapy, Pulmonary function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 5 Nov 2023 (actual)
- First posted
- 13 Mar 2023 (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.
In this study, it was aimed to evaluate the effect of spinal mobilization techniques applied in addition to core stabilization exercises in Adolescent Idiopathic Scoliosis (AIS) patients.
Consecutive adolescents with idiopathic scoliosis, aged 10 to 16 years, without a brace, and with a Cobb curvature of 10 to 25 degrees were randomly divided into two groups using the closed envelope method: Spinal mobilization and core stabilization exercise were applied to the experimental group; Only core stabilization exercises were applied to the control group.
Both groups received interventions twice a week for 10 weeks. Outcome measurements were made before treatment and after 10 weeks of treatment.
Detailed description
This study was a randomized controlled trial in which participants and assessor were blinded. This study was carried out in Amasya University Ruhi Tingiz Physical Therapy and Rehabilitation Hospital Rehabilitation Unit between August 2022 and January 2023. Ethics committee approval was obtained from Amasya University (E-76988455-050.01.04-83314) on 05.08.2022 to conduct the study. Before the study, face-to-face interviews were conducted with the all participants and parents and informed about the subject and purpose of the study. Verbal and written consent was obtained from the all participants and parents.
Sample size: The sample of the study was calculated with the G*Power 3.1 program, and the effect size (d=1.0) was calculated according to the double-tailed hypothesis method, taking into account the study. (d=1.0; α=0.05; 1-ß=0.80). Confidence interval was determined as 80% and margin of error was 5% (α=0.05). As a result of the calculation, it was determined that there should be 17 adolescent scoliosis patients for the control group, 17 for the experimental group, and a total of 34 adolescent scoliosis patients. Considering the possible data losses of the participants, we planned to include a total of 40 participants, 20 in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal mobilization group | Experimental | Other: Spinal mobilization, Other: Core stabilization exercise |
| Core stabilization exercise group | Active comparator | Other: Core stabilization exercise |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients diagnosed with AIS
- Age 10-16 years
- Cobb angle was between 10° and 25
- Risser sing did not exceed 4
- Informed consent forms were signed by the parents and children
Key exclusion criteria (4 listed)
- Used brace,
- Had previous spinal surgery, inferior limb length difference,
- Could not exercise due to another injury/diagnosis,
- Had neuromuscular, psychiatric, cardiovascular, respiratory insufficiency and mental disability
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 |
|---|---|---|
| Spinal mobilizationSpinal mobilization and core stabilization exercise | Other | Spinal mobilization group |
| Core stabilization exerciseStabilization exercises for the spine | Other | Core stabilization exercise group, Spinal mobilization group |
Primary outcome
Cobb angle
Time frame: Change from pretreatment and 10 weeks after treatment.
The most accepted way of scoliosis evaluation is Cobb angle measurement performed on frontal plane x-ray. The Cobb angle is the curvature of the spine, and measuring it is essential for determining the severity of scoliosis, selecting the best course of action, and monitoring the progression or regression of cases following treatment. The Cobb angle measure as the vertically intersecting angle after determining the vertebrae above the apex and below the apex, which are the most tilted from the concave side of the curvature of the spine.
7 secondary outcomes
Angle of Trunk Rotation
Time frame: Change from pretreatment and 10 weeks after treatment.
Pulmonary Functions Test- PEF (Peak expiratory flow)
Time frame: Change from pretreatment and 10 weeks after treatment.
Pulmonary Functions Test- FEV1 (Forced expiratory volume in the first second)
Time frame: Change from pretreatment and 10 weeks after treatment.
Pulmonary Functions Test-FVC (Forced vital capacity)
Time frame: Change from pretreatment and 10 weeks after treatment.
Pulmonary Functions Test- FEV1/FVC
Time frame: Change from pretreatment and 10 weeks after treatment.
Walter Reed Visual Assessment Scale
Time frame: Change from pretreatment and 10 weeks after treatment.
Scoliosis Research Society-22
Time frame: Change from pretreatment and 10 weeks after treatment.
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 5 Mar 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.
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 Spinal mobilization and Core stabilization exercise in people with Adolescent Idiopathic Scoliosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 5 Mar 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 Turkey (Türkiye). 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: Change from pretreatment and 10 weeks after treatment.). 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 5 Mar 2024.