ScoliosisNCT07447193
Investigation of Pain Perception According to Gender in Individuals With Scoliosis
A study testing exercise in people with Scoliosis, run by Uskudar University at 1 site in Azerbaijan.
Trial summary
The aim of this study is to evaluate whether pain perception under spinal pressure created on a physiotherapy roller differs according to gender in individuals diagnosed with scoliosis. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAzerbaijan
- Study dates
- 1 Apr 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a clinical or radiological diagnosis of scoliosis
- Being between 18-45 years of age
- Not having undergone scoliosis surgery in the last 6 months
- Agreeing to participate in the study voluntarily
Who cannot join
- Having a history of neurological disease
- Acute inflammatory spinal disease
- Serious cardiovascular or systemic diseases that would prevent participation in exercise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Azerbaijan1 site, 1 recruiting
- Recruiting
Badam Medical Center
Baku
Aynur SHIRALIZADA
About this study
The aim of this study is to evaluate whether pain perception under spinal pressure created on a physiotherapy roller differs according to gender in individuals diagnosed with scoliosis.
Read the detailed description
This study will be conducted using a single-group pre-test-post-test quasi-experimental design. Participants will undergo sports physiotherapy-based exercises designed to create controlled mechanical pressure on the spine using a physiotherapy roller. The aim of the exercises is to evaluate the changes in pain perception during the pressure created on the spinal infrastructure and the postural control mechanisms specific to scoliosis, and whether these changes differ according to gender. The exercise program will be applied three days a week for a total of six weeks, with each exercise session lasting approximately 45 minutes. All applications will be performed under the supervision of a physiotherapist, and the spinal pressure created on the physiotherapy roller during the exercises will be controlled and within the limits that individuals can tolerate. The physiotherapy roller will be used as the main equipment in this study, not as an auxiliary tool, and will ensure that spinal pressure is created in a standard manner. Pain assessment will be conducted in two stages: before the exercise program (pre-test) and after the exercise program is completed (post-test).
- Conditions
- Scoliosis
- Being tested
- exercise
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
The exercise program will be implemented three days a week for a total of six weeks, with each exercise session planned to be approximately 45 minutes long. All applications will be carried out under the supervision of a physiotherapist, and the spinal pressure created on the physiotherapy cylinder during the exercises will be controlled and applied within the limits that individuals can tolerate. The physiotherapy cylinder will be used as the main equipment, not an auxiliary one, in this study and will ensure that spinal pressure is created in a standard manner.
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Experimental | exercise will be given Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoliosis Research Society-22
Scoliosis Research Society-22 is a functional survey for the patient to fill out on their scoliosis. This survey has been validated in the literature. It is a 22 question survey on the functional status and pain that a patient experiences. Created by the scoliosis research society. There is a scoring rubric that goes with the survey. This survey has 5 domains that are covered with the minimum score of 22 and the maximum score of 110. The higher the score the better the patient is doing in the domains of: Activities of Daily Living, Mental Health, Pain, Patient Satisfaction, Positive Affect, Quality of Life, Social Relationships, and Stress/Coping.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Apr 2026
- Primary completion15 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doç.Dr.Ömer Şevgin, Uskudar University
- Investigators
- Aynur SHIRALIZADA, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447193
- Sponsor's protocol ID
- Uskudar90
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khodaei M, Parent EC, Wong J, Chan A, Coutts B, Dlikan M, Fehr B, Logithasan V, Sayed T, Mendoza A, Ganzert C, Lou EHM. Identifying predictors of brace treatment outcomes for adolescents or adults with idiopathic scoliosis: a systematic review. Eur Spine J. 2025 May;34(5):1827-1848. doi: 10.1007/s00586-025-08736-w. Epub 2025 Feb 26.
PubMed 40009184Bourtzoni S, Reed P. Pain perception in personality disorders. PLoS One. 2025 May 9;20(5):e0323004. doi: 10.1371/journal.pone.0323004. eCollection 2025.
PubMed 40343930Gur G, Ayhan C, Yakut Y. The effectiveness of core stabilization exercise in adolescent idiopathic scoliosis: A randomized controlled trial. Prosthet Orthot Int. 2017 Jun;41(3):303-310. doi: 10.1177/0309364616664151. Epub 2016 Sep 13.
PubMed 27625122
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pain Perception According to Gender in Individuals With Scoliosis
- ClinicalTrials.gov ID
- NCT07447193
- Acronym / sponsor ID
- Uskudar90
- Conditions
- Scoliosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Mar 2026 (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.
The aim of this study is to evaluate whether pain perception under spinal pressure created on a physiotherapy roller differs according to gender in individuals diagnosed with scoliosis.
Detailed description
This study will be conducted using a single-group pre-test-post-test quasi-experimental design. Participants will undergo sports physiotherapy-based exercises designed to create controlled mechanical pressure on the spine using a physiotherapy roller. The aim of the exercises is to evaluate the changes in pain perception during the pressure created on the spinal infrastructure and the postural control mechanisms specific to scoliosis, and whether these changes differ according to gender. The exercise program will be applied three days a week for a total of six weeks, with each exercise session lasting approximately 45 minutes. All applications will be performed under the supervision of a physiotherapist, and the spinal pressure created on the physiotherapy roller during the exercises will be controlled and within the limits that individuals can tolerate. The physiotherapy roller will be used as the main equipment in this study, not as an auxiliary tool, and will ensure that spinal pressure is created in a standard manner. Pain assessment will be conducted in two stages: before the exercise program (pre-test) and after the exercise program is completed (post-test).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise group | Experimental | Other: exerciseexercise will be given |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having a clinical or radiological diagnosis of scoliosis
- Being between 18-45 years of age
- Not having undergone scoliosis surgery in the last 6 months
- Agreeing to participate in the study voluntarily
Key exclusion criteria (3 listed)
- Having a history of neurological disease
- Acute inflammatory spinal disease
- Serious cardiovascular or systemic diseases that would prevent participation in exercise
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 |
|---|---|---|
| exerciseThe exercise program will be implemented three days a week for a total of six weeks, with each exercise session planned to be approximately 45 minutes long. All applications will be carried out under the supervision of a physiotherapist, and the spinal pressure created on the physiotherapy cylinder during the exercises will be controlled and applied within the limits that individuals can tolerate. The physiotherapy cylinder will be used as the main equipment, not an auxiliary one, in this study and will ensure that spinal pressure is created in a standard manner. | Other | exercise group |
Primary outcome
Scoliosis Research Society-22
Time frame: 8 weeks
Scoliosis Research Society-22 is a functional survey for the patient to fill out on their scoliosis. This survey has been validated in the literature. It is a 22 question survey on the functional status and pain that a patient experiences. Created by the scoliosis research society. There is a scoring rubric that goes with the survey. This survey has 5 domains that are covered with the minimum score of 22 and the maximum score of 110. The higher the score the better the patient is doing in the domains of: Activities of Daily Living, Mental Health, Pain, Patient Satisfaction, Positive Affect, Quality of Life, Social Relationships, and Stress/Coping.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 40009184Khodaei M, Parent EC, Wong J, Chan A, Coutts B, Dlikan M, Fehr B, Logithasan V, Sayed T, Mendoza A, Ganzert C, Lou EHM. Identifying predictors of brace treatment outcomes for adolescents or adults with idiopathic scoliosis: a systematic review. Eur Spine J. 2025 May;34(5):1827-1848. doi: 10.1007/s00586-025-08736-w. Epub 2025 Feb 26.
- Background: PubMed 40343930Bourtzoni S, Reed P. Pain perception in personality disorders. PLoS One. 2025 May 9;20(5):e0323004. doi: 10.1371/journal.pone.0323004. eCollection 2025.
- Background: PubMed 27625122Gur G, Ayhan C, Yakut Y. The effectiveness of core stabilization exercise in adolescent idiopathic scoliosis: A randomized controlled trial. Prosthet Orthot Int. 2017 Jun;41(3):303-310. doi: 10.1177/0309364616664151. Epub 2016 Sep 13.
- Individual participant dataSharing planned: No
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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.
Aynur SHIRALIZADA study chair
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Scoliosis, run by Uskudar University at 1 site in Azerbaijan.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. 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 Azerbaijan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ömer ŞEVGİN (+905069787535, omer.sevgin@uskudar.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoliosis Research Society-22 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07447193, which also lists 3 linked publications.
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 9 Apr 2026.