- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07447193
Investigation of Pain Perception According to Gender in Individuals With Scoliosis
April 3, 2026 updated by: Doç.Dr.Ömer Şevgin, Uskudar University
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.
Study Overview
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 Type
Interventional
Enrollment (Estimated)
50
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 Contact
- Name: Ömer ŞEVGİN
- Phone Number: +905069787535
- Email: omer.sevgin@uskudar.edu.tr
Study Locations
-
-
-
Baku, Azerbaijan
- Recruiting
- Badam Medical Center
-
Contact:
- Aynur SHIRALIZADA
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having a history of neurological disease
- Acute inflammatory spinal disease
- Serious cardiovascular or systemic diseases that would prevent participation in exercise
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: exercise group
exercise will be given
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Aynur SHIRALIZADA, Uskudar University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gur 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.
- 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.
- Bourtzoni S, Reed P. Pain perception in personality disorders. PLoS One. 2025 May 9;20(5):e0323004. doi: 10.1371/journal.pone.0323004. eCollection 2025.
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)
April 1, 2026
Primary Completion (Estimated)
May 15, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
February 25, 2026
First Submitted That Met QC Criteria
February 25, 2026
First Posted (Actual)
March 3, 2026
Study Record Updates
Last Update Posted (Actual)
April 9, 2026
Last Update Submitted That Met QC Criteria
April 3, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uskudar90
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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