- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07250295
The Effect of Exercise on Paravertebral Muscle Thickness and Quality of Life in Adolescent Idiopathic Scoliosis
January 7, 2026 updated by: Roza Jizel Dagdelen MD, Sisli Hamidiye Etfal Training and Research Hospital
The study population comprised patients with AIS who had applied to the outpatient clinic between January and June 2022.
The patients were divided into two groups.
Treatment group(TG) was instructed in specific scoliosis exercises, while the Control group(CG) was given exercises for the lower extremities.
Each patient was included in a 12- week exercise program accompanied by a physiotherapist.
The patients' quality of life, and paravertebral muscles were evaluated ultrasonographically before and after treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey (Türkiye)
- Hamidiye Etfal Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients who had been diagnosed with AIS by means of radiographic and clinical examination of the spine were included in the study.
Exclusion Criteria:
- Cases with a history of surgery to the paravertebral region
- Metabolic bone disease
- Neuromuscular disease
- chromosomal anomaly
- Serious autoimmune and endocrine disease
- Congenital scoliosis
- Skeletal dysplasia and serious cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Treatment Group
The treatment group (TG) was given exercises for the thoracic and lumbar regions for scoliosis.
|
Patients were expected to attend treatment under the supervision of a physiotherapist.
If they missed a day, they were contacted by phone and advised to do their exercises at home.
The number of days they missed did not exceed five.
Each set included a 30-second rest period to prevent fatigue.
A five-minute warm-up and cool-down period was allotted before and after the exercise session.
The exercise program was implemented by a physiotherapist with three years of experience in scoliosis management.
Before initiating the intervention, the physiotherapist underwent a structured training session, including practical demonstrations, supervised practice, and detailed exercise protocols.
|
|
Placebo Comparator: Control Group
The control group (CG) was instructed to perform gluteus maximus, hamstring, and quadriceps strengthening exercises.
|
The control group (CG) was instructed to perform gluteus maximus, hamstring, and quadriceps strengthening exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Paravertebral Muscle Thickness in Ultrasonographic Measurements
Time Frame: 12 weeks
|
A standard imaging protocol was employed for the transverse imaging of the thoracic and lumbar multifidus muscles.
Pre- and post-exercise measurements were performed by the same physician who was blinded to the exercise program the patient received.
This evaluator was a PMR physician with 3 years of experience in the field of ultrasound.
For each ultrasound image, the examiner positioned the probe over the spinous process and then moved it laterally and proceeded to image the multifidus and deep thoracic paravertebral muscles on both the convex and concave sides of the apex with the patient positioned prone.
Two images were obtained for each segment on each side.
The mean of the two trials was employed for the purpose of data analysis.
|
12 weeks
|
|
The Turkish version of the Spinal Appearance Questionnaire (Tr-SGA)
Time Frame: 12 weeks
|
The questionnaire comprises two distinct sections: one pertaining to appearance and the other to expectations.
Each section contains a series of questions presented on a 5-point Likert scale.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Short Form-36 Health Status Questionnaire (SF-36)
Time Frame: 12 weeks
|
The Short Form-36 Health Status Questionnaire (SF-36) was employed for the purpose of assessing quality of life.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
August 15, 2022
Study Registration Dates
First Submitted
November 18, 2025
First Submitted That Met QC Criteria
November 18, 2025
First Posted (Estimated)
November 26, 2025
Study Record Updates
Last Update Posted (Actual)
January 9, 2026
Last Update Submitted That Met QC Criteria
January 7, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28.12.2021 / 3388
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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