Spine DeformityNCT07459400
The Effect of Peloidotherapy in Young Adults Undergoing Physical Therapy Scoliosis Specific Exercises (PSSE)
An observational study of Spine Deformity and Adult Scoliosis, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Scoliosis is a musculoskeletal disorder defined by a three-dimensional spinal deformity that can result in substantial clinical and functional limitations, particularly during adolescence and young adulthood. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Spine Deformity, Adult Scoliosis, Peloidotherapy
- What is being tested?
- Adult Scoliosis Study Form, Scoliosis graphy and Visuel Aanalog Scale
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Mar 2026to 23 Oct 2026
- How long will I take part?
- 4 Months
- Phase
- Observational
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study aims to investigate the effects of peloidotherapy combined with a Physiotherapeutic Scoliosis-Specific Exercise (PSSE) program on pain intensity, quality of life, and exercise adherence in patients with idiopathic scoliosis followed at the Scoliosis Clinic of the Department of Physical Medicine and Rehabilitation, Gaziosmanpaşa Training and Research Hospital. Patients scheduled for Barcelona Schroth-based PSSE will be recruited. Demographic data will be recorded. Participants will be randomized into study and control groups using the envelope method. Individuals aged 20-40 years, with a baseline VAS score ≥3 and pain lasting longer than three months, will be included. The study will be single-blinded, and outcomes will be assessed by a blinded evaluator.
Who may be able to join
- Aged 20-40 years
- Diagnosed with idiopathic scoliosis by a specialist physician
- Cobb angle between 15-40 degrees
- Able to perform PSSE exercises throughout the study period
- VAS ≥3 at the start of the study
- Has had pain complaints for at least 3 months
- Individuals who have agreed in writing to participate in the study
Who cannot join
- Individuals who have undergone scoliosis surgery
- Individuals with neuromuscular, congenital, or secondary scoliosis
- Individuals with rheumatological, inflammatory, or serious chronic diseases (such as cardiopulmonary insufficiency or kidney disease)
- Pregnant and breastfeeding women
- Conditions in which peloidotherapy is contraindicated (active skin infection, open wound, serious dermatological disease, history of allergic reaction, severe cardiopulmonary, kidney or liver failure, bleeding disorder or anticoagulant use, pregnancy/breastfeeding, and systemic infection)
- Individuals with serious psychiatric disorders that may interfere with treatment compliance or affect consent
- Individuals receiving additional physical therapy during the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpasa Training and Research Hospital
Istanbul, Gaziosmanpasa, 34255
Sinem Turkmen Ozoguz, MD, +90 554 820 47 69, turkmen_sinem@hotmail.com
Deniz Oke, MD, +90 532 430 69 50, dr_denizoke@hotmail.com
About this study
Official title: The Effect of Peloidotherapy on Pain and Quality of Life in Young Adult Individuals With Scoliosis Undergoing Physiotherapy Scoliosis-Specific Exercises (PSSE)
Scoliosis is a musculoskeletal disorder defined by a three-dimensional spinal deformity that can result in substantial clinical and functional limitations, particularly during adolescence and young adulthood. Affected individuals commonly experience postural asymmetry, muscular imbalance, pain, and diminished quality of life. In conservative management, Physiotherapeutic Scoliosis-Specific Exercises (PSSE) have gained recognition as a fundamental intervention. The primary objectives of PSSE include optimizing spinal alignment, facilitating rotational breathing, and restoring muscular symmetry to improve functional capacity. Evidence from systematic reviews suggests that PSSE, especially the Schroth method, are superior to general exercise programs in improving both radiographic parameters and health-related quality of life.Meta-analytic findings further support the effectiveness of PSSE in reducing curve magnitude and enhancing quality of life outcomes. Among the various PSSE approaches, the Schroth method is one of the most extensively investigated and widely applied in clinical settings. This method incorporates three-dimensional postural correction, targeted breathing techniques, and the development of postural awareness. Randomized controlled trials have demonstrated that Schroth exercises significantly improve SRS-22 quality of life scores and positively influence pain, body image, and overall well-being.Despite these established benefits, pain and muscle tension occurring during exercise sessions may negatively influence adherence to rehabilitation programs. In young adults, pain is a critical factor limiting treatment compliance and restricting engagement in daily activities. Accordingly, adjunctive interventions implemented prior to exercise may enhance exercise tolerance and optimize therapeutic outcomes.Peloidotherapy, which involves the therapeutic application of natural medicinal mud, is commonly used in musculoskeletal rehabilitation due to its analgesic, muscle-relaxant, and circulation-enhancing effects. By alleviating pain and reducing muscular tension, peloidotherapy may facilitate greater participation in exercise programs and support improved clinical outcomes.This study aims to investigate the effects of adjunctive peloidotherapy administered before Schroth-based PSSE in young adults with scoliosis, focusing on pain, exercise adherence, and quality of life, with particular emphasis on SRS-22 measures..
Read the detailed description
Scoliosis is a musculoskeletal disorder characterized by a three-dimensional spinal deformity that can cause clinical and functional problems, particularly during adolescence and young adulthood. Postural abnormalities, muscle imbalances, pain, and decreased quality of life are frequently reported in individuals with scoliosis.Non-surgical conservative approaches are of great importance, especially in mild to moderate curvatures, to control the progression of the deformity, increase functional capacity, and reduce symptoms.
In recent years, scoliosis-specific physiotherapy exercises (Physiotherapeutic Scoliosis-Specific Exercises - PSSE) have been accepted as an indispensable part of conservative treatment. PSSE are exercises designed for the three-dimensional nature of spinal curvature and are planned specifically for the patient's curvature pattern. These exercises aim to increase the functional capacity of the spine by targeting correct posture, rotational breathing, and muscle balance. Systematic reviews have shown that PSSE, particularly the Schroth approach, is more effective than other types of exercise in improving quality of life and curvature parameters.
In particular, meta-analyses have indicated that PSSE provides relative improvements in quality of life and degree of curvature. Schroth exercises are one of the most studied and widely used methods in clinical practice for PSSE. The Schroth method involves three-dimensional postural correction, rotational breathing techniques, and increased postural awareness. Controlled randomized studies have reported that Schroth exercises provide significant improvements in SRS-22 quality of life scores and have positive effects on pain, body awareness, and quality of life parameters.
Although PSSE Schroth exercises have been shown to have positive effects on quality of life and curvature parameters in individuals with scoliosis, pain and muscle tension that arise during the exercise process can negatively affect individuals' adherence to the exercise program. The presence of pain is a significant factor limiting treatment compliance and daily living activities, especially in young adults. At this point, complementary treatment methods that can be applied before exercise have the potential to increase treatment effectiveness.
Peloidotherapy is a physical therapy method involving the application of natural therapeutic mud and is used for musculoskeletal disorders due to its pain-relieving, muscle-relaxing, and circulation-enhancing effects. These therapeutic applications have potential benefits in increasing exercise tolerance and improving quality of life. However, there are a limited number of studies on the effectiveness of peloidotherapy when combined with PSSE programs.
The rationale for this study is to scientifically evaluate the effect of peloidotherapy, applied additionally before exercise in young adult individuals with scoliosis undergoing the PSSE Schroth exercise program, on pain, exercise compliance, and quality of life (particularly SRS-22).
While the literature supports the positive effects of Schroth exercises on quality of life, the potential benefits of these effects in combination therapies have not yet been sufficiently investigated. The findings are expected to provide innovative contributions to conservative scoliosis treatment protocols and shed light on the development of multidisciplinary approaches in clinical practice.
- Conditions
- Spine Deformity, Adult Scoliosis, Peloidotherapy
- Being tested
- Adult Scoliosis Study Form, Scoliosis graphy, Visuel Aanalog Scale, Adam's Test, TRACE (Trunk Aesthetic Clinical Evaluation)
- Keywords
- Peloidotherapy, Adult Scoliosis, Physiotherapy Scoliosis-Specific Exercises (PSSE), Pain, Quality of Life
- Medical subject headings
- Scoliosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult Scoliosis Study FormDiagnostic test
The adult scoliosis form, which includes demographic data, clinical and radiological measurements of patients aged 20-40 who present to the outpatient clinic with adult scoliosis, will be completed in detail.
Scoliosis graphyDiagnostic test
Patients with results from the forward bending test and clinical evaluation consistent with scoliosis must have had a scoliosis X-ray taken within the last year. Coronal and sagittal balance; coronal and sagittal Cobb angles will be measured from posterior-anterior (PA) and lateral scoliosis radiographs.
Visuel Aanalog ScaleDiagnostic test
Pain in adults with scoliosis will be assessed and recorded using the visual analog scale. Adults with scoliosis who report pain above VAS>3 will be included in the assessment.
Adam's TestDiagnostic test
The Adams test (forward bending test) (+) will be measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation- trunk rotation) measurements. Trunk rotation is a common component of scoliosis. It adds a twisting motion to the curvature of the spine. You can think of it like a spiral staircase turning upward. In scoliosis, the apical vertebra and vertebrae, which are the bones of the spine, can also twist, causing the ribs to twist with them. This bending is measured by the trunk rotation angle (trunk rotation angle or ATR). A higher ATR means that the bending of the body is more pronounced. The Cobb angle can be estimated using scoliometer measurements of the trunk rotation angle (ATR).
TRACE (Trunk Aesthetic Clinical Evaluation)Other
Aesthetic appearance is a primary consideration in the treatment of scoliosis. This has been clearly stated in a consensus by SOSORT experts, in which aesthetic improvement has become the main goal of scoliosis treatment.TRACE is based on four sub-scales: shoulders, scapulae and waist (which were already present in the AI), and the hemithorax. However, the scores for each sub-scale were changed with respect to AI: shoulders now ranged from 0-3, waist from 0-4, scapulae from 0-2 and hemithorax from 0-2. From these sub-scales we calculated TRACE, using the sum of the sub-scale scores to reach a 12-point scale
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Patients diagnosed with scoliosis deformity beginning in adulthood between the ages of 20 and 40 The scoliosis study form, consisting of clinical and radiological measurements of patients between the ages of 20 and 40 who have been diagnosed with scoliosis beginning in adulthood and who have applied to the scoliosis clinic, will be filled out in detail. Individuals included in the study group through randomization will receive both peloidotherapy and PSSE. Receives: Diagnostic Test: Adult Scoliosis Study Form; Diagnostic Test: Scoliosis graphy; Diagnostic Test: Visuel Aanalog Scale; Diagnostic Test: Adam's Test; Other: TRACE (Trunk Aesthetic Clinical Evaluation) | |
| Control group | Patients diagnosed with scoliosis deformity beginning in adulthood between the ages of 20 and 40 The scoliosis study form, consisting of clinical and radiological measurements of patients between the ages of 20 and 40 who have been diagnosed with scoliosis beginning in adulthood and who have applied to the scoliosis clinic, will be filled out in detail. Individuals included in the control group through randomization will only receive PSSE. Receives: Diagnostic Test: Adult Scoliosis Study Form; Diagnostic Test: Scoliosis graphy; Diagnostic Test: Visuel Aanalog Scale; Diagnostic Test: Adam's Test; Other: TRACE (Trunk Aesthetic Clinical Evaluation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adam's Test
The Adams test (forward bending test) (+) will be measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation- trunk rotation) measurements. Trunk rotation is a common component of scoliosis. It adds a twisting motion to the curvature of the spine. You can think of it like a spiral staircase turning upward. In scoliosis, the apical vertebra and vertebrae, which are the bones of the spine, can also twist, causing the ribs to twist with them. This bending is measured by the trunk rotation angle (trunk rotation angle or ATR). A higher ATR means that the bending of the body is more pronounced. The Cobb angle can be estimated using scoliometer measurements of the trunk rotation angle (ATR).
Measured: At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
Visuel Aanalog Scale
Pain in adults with scoliosis will be assessed and recorded using the visual analog scale. Adults with scoliosis who report pain above VAS>3 will be included in the assessment. The Visual Analog Scale (VAS) is a subjective pain measurement tool where patients indicate the intensity of their pain by marking a point on a 10 cm (100 mm) horizontal line. The beginning of the line represents "no pain," and the end represents "the most severe pain imaginable." The marked point is measured between 0-10 cm (or 0-100 mm) and converted into a score, and is widely used in clinical pain assessment.
Measured: At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
TRACE (Trunk Aesthetic Clinical Evaluation)
Aesthetic appearance is a primary consideration in the treatment of scoliosis. This has been clearly stated in a consensus by SOSORT experts, in which aesthetic improvement has become the main goal of scoliosis treatment.TRACE is based on four sub-scales: shoulders, scapulae and waist (which were already present in the AI), and the hemithorax. However, the scores for each sub-scale were changed with respect to AI: shoulders now ranged from 0-3, waist from 0-4, scapulae from 0-2 and hemithorax from 0-2. From these sub-scales we calculated TRACE, using the sum of the sub-scale scores to reach a 12-point scale
Measured: At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
SRS-22r (Scoliosis Research Society Score)
The SRS-22r is a validated questionnaire intended to assess outcomes in patients with idiopathic scoliosis after spinal surgery. The first version, developed by the Scoliosis Research Society in 1999, had 24 items, and this was reduced to 22 items (accompanied by a name change) in the course of 3 major updates.The SRS-22 contains 22 questions covering 5 domains: function/activity 5 items; pain 5 items; self-perceived image 5 items; mental health 5 items; and satisfaction with treatment 2 items. Each item is scored from 1 (worst) to 5 (best). Each domain has a total sum score ranging from 5 to 25, except for satisfaction, which ranges from 2 to 10. The sum of the first 4 domains gives a maximum subtotal of 100, and when the satisfaction domain is included, the maximum total is 110
Measured: At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
Secondary outcomes (2)
Questionnaire of Physiotherapeutic Specific Exercises of Scoliosis-QPSSE
The application of Physiotherapeutic Specific Exercises for Scoliosis (PSEE) alone or with bracing is currently one of the therapeutic models for mild and moderate IS (Idıopathic Scoliosis). The questionnaire consists of 53 questions and eight domains. The eight domains of the final questionnaire were as follows: (1) physical functioning, (2) self-image, (3) Physiotherapeutic Scoliosis-Specific Exercises (PSSEs), (4) psychosocial functioning, (5) cognitive functioning, (6) compliance, (7) motivation, and (8) pain. There are 37 with positive meaning and 15 with negative meaning and 1 multiple choice question. Furthermore, 6 open-ended questions were included related to the PSSEs and the questionnaire. In the scored items, a Likert scale of 1 -5 was used. More specifically, responses 1-5 correspond to 5 = Strongly agree and 1 = Strongly disagree. An additional edit was made to the wording of the questions so that they could correspond meaningfully to these responses.
Measured: At the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
Beck Depression Inventory
The Beck Depression Inventory (BDI) is a 21-item, self-rated scale that evaluates key symptoms of depression including mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, suicidal ideas, crying, irritability, social withdrawal, indecisiveness, body image change, work difficulty, insomnia, fatigability, loss of appetite, weight loss, somatic preoccupation, and loss of libido. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Higher scores indicate greater depressive severity
Measured: At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start23 Mar 2026
- Primary completion25 Sep 2026 (estimated)
- Study completion23 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spine DeformityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sinem Turkmen Ozoguz, MD, Principal investigator, Gaziosmanpasa Training and Research Hospital Physical Rehabilitation DepartmentDeniz Oke, MD, Study chair, Gaziosmanpasa Training and Research Hospital Physical Rehabilitation DepartmentEbru Yilmaz Yalcinkaya, MD,Professor, Study director, Gaziosmanpasa Training and Research Hospital Physical Rehabilitation DepartmentSerap Seringec Karabulut, MD, Study chair, Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459400
- Sponsor's protocol ID
- 22.01.2026-139
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jia K, Yang Y. Effect of acupuncture and massage on adolescent idiopathic scoliosis and pain severity. Front Med (Lausanne). 2025 Jul 21;12:1613800. doi: 10.3389/fmed.2025.1613800. eCollection 2025.
PubMed 40761866Karaarslan F, Yilmaz H, Akkurt HE, Gul S, Kardes S. Effectiveness of peloid therapy in patients with chronic low back pain: a single-blind controlled study. Int J Biometeorol. 2021 Nov;65(11):1799-1809. doi: 10.1007/s00484-021-02137-6. Epub 2021 May 1.
PubMed 33931829Schreiber S, Parent EC, Moez EK, Hedden DM, Hill D, Moreau MJ, Lou E, Watkins EM, Southon SC. The effect of Schroth exercises added to the standard of care on the quality of life and muscle endurance in adolescents with idiopathic scoliosis-an assessor and statistician blinded randomized controlled trial: "SOSORT 2015 Award Winner". Scoliosis. 2015 Sep 18;10:24. doi: 10.1186/s13013-015-0048-5. eCollection 2015.
PubMed 26413145Kyrkousis A, Iakovidis P, Chatziprodromidou IP, Lytras D, Kasimis K, Apostolou T, Koutras G. Effects of a Long-Term Supervised Schroth Exercise Program on the Severity of Scoliosis and Quality of Life in Individuals with Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial Study. Medicina (Kaunas). 2024 Oct 7;60(10):1637. doi: 10.3390/medicina60101637.
PubMed 39459424Dong H, You M, Li Y, Wang B, Huang H. Physiotherapeutic Scoliosis-Specific Exercise for the Treatment of Adolescent Idiopathic Scoliosis: A Systematic Review and Network Meta-analysis. Am J Phys Med Rehabil. 2024 Jan 1;104(1):14-25. doi: 10.1097/PHM.0000000000002524. Epub 2024 May 10.
PubMed 38726971Negrini S, Hresko TM, O'Brien JP, Price N; SOSORT Boards; SRS Non-Operative Committee. Recommendations for research studies on treatment of idiopathic scoliosis: Consensus 2014 between SOSORT and SRS non-operative management committee. Scoliosis. 2015 Mar 7;10:8. doi: 10.1186/s13013-014-0025-4. eCollection 2015.
PubMed 25780381
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peloidotherapy on Pain and Quality of Life in Young Adult Individuals With Scoliosis Undergoing Physiotherapy Scoliosis-Specific Exercises (PSSE)
- ClinicalTrials.gov ID
- NCT07459400
- Acronym / sponsor ID
- 22.01.2026-139
- Conditions
- Spine Deformity, Adult Scoliosis, Peloidotherapy
- Keywords
- Peloidotherapy, Adult Scoliosis, Physiotherapy Scoliosis-Specific Exercises (PSSE), Pain, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 23 Oct 2026 (estimated)
- First posted
- 9 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.
Scoliosis is a musculoskeletal disorder defined by a three-dimensional spinal deformity that can result in substantial clinical and functional limitations, particularly during adolescence and young adulthood. Affected individuals commonly experience postural asymmetry, muscular imbalance, pain, and diminished quality of life. In conservative management, Physiotherapeutic Scoliosis-Specific Exercises (PSSE) have gained recognition as a fundamental intervention. The primary objectives of PSSE include optimizing spinal alignment, facilitating rotational breathing, and restoring muscular symmetry to improve functional capacity. Evidence from systematic reviews suggests that PSSE, especially the Schroth method, are superior to general exercise programs in improving both radiographic parameters and health-related quality of life.Meta-analytic findings further support the effectiveness of PSSE in reducing curve magnitude and enhancing quality of life outcomes. Among the various PSSE approaches, the Schroth method is one of the most extensively investigated and widely applied in clinical settings. This method incorporates three-dimensional postural correction, targeted breathing techniques, and the development of postural awareness. Randomized controlled trials have demonstrated that Schroth exercises significantly improve SRS-22 quality of life scores and positively influence pain, body image, and overall well-being.Despite these established benefits, pain and muscle tension occurring during exercise sessions may negatively influence adherence to rehabilitation programs. In young adults, pain is a critical factor limiting treatment compliance and restricting engagement in daily activities. Accordingly, adjunctive interventions implemented prior to exercise may enhance exercise tolerance and optimize therapeutic outcomes.Peloidotherapy, which involves the therapeutic application of natural medicinal mud, is commonly used in musculoskeletal rehabilitation due to its analgesic, muscle-relaxant, and circulation-enhancing effects. By alleviating pain and reducing muscular tension, peloidotherapy may facilitate greater participation in exercise programs and support improved clinical outcomes.This study aims to investigate the effects of adjunctive peloidotherapy administered before Schroth-based PSSE in young adults with scoliosis, focusing on pain, exercise adherence, and quality of life, with particular emphasis on SRS-22 measures..
Detailed description
Scoliosis is a musculoskeletal disorder characterized by a three-dimensional spinal deformity that can cause clinical and functional problems, particularly during adolescence and young adulthood. Postural abnormalities, muscle imbalances, pain, and decreased quality of life are frequently reported in individuals with scoliosis.Non-surgical conservative approaches are of great importance, especially in mild to moderate curvatures, to control the progression of the deformity, increase functional capacity, and reduce symptoms.
In recent years, scoliosis-specific physiotherapy exercises (Physiotherapeutic Scoliosis-Specific Exercises - PSSE) have been accepted as an indispensable part of conservative treatment. PSSE are exercises designed for the three-dimensional nature of spinal curvature and are planned specifically for the patient's curvature pattern. These exercises aim to increase the functional capacity of the spine by targeting correct posture, rotational breathing, and muscle balance. Systematic reviews have shown that PSSE, particularly the Schroth approach, is more effective than other types of exercise in improving quality of life and curvature parameters.
In particular, meta-analyses have indicated that PSSE provides relative improvements in quality of life and degree of curvature. Schroth exercises are one of the most studied and widely used methods in clinical practice for PSSE. The Schroth method involves three-dimensional postural correction, rotational breathing techniques, and increased postural awareness. Controlled randomized studies have reported that Schroth exercises provide significant improvements in SRS-22 quality of life scores and have positive effects on pain, body awareness, and quality of life parameters.
Although PSSE Schroth exercises have been shown to have positive effects on quality of life and curvature parameters in individuals with scoliosis, pain and muscle tension that arise during the exercise process can negatively affect individuals' adherence to the exercise program. The presence of pain is a significant factor limiting treatment compliance and daily living activities, especially in young adults. At this point, complementary treatment methods that can be applied before exercise have the potential to increase treatment effectiveness.
Peloidotherapy is a physical therapy method involving the application of natural therapeutic mud and is used for musculoskeletal disorders due to its pain-relieving, muscle-relaxing, and circulation-enhancing effects. These therapeutic applications have potential benefits in increasing exercise tolerance and improving quality of life. However, there are a limited number of studies on the effectiveness of peloidotherapy when combined with PSSE programs.
The rationale for this study is to scientifically evaluate the effect of peloidotherapy, applied additionally before exercise in young adult individuals with scoliosis undergoing the PSSE Schroth exercise program, on pain, exercise compliance, and quality of life (particularly SRS-22).
While the literature supports the positive effects of Schroth exercises on quality of life, the potential benefits of these effects in combination therapies have not yet been sufficiently investigated. The findings are expected to provide innovative contributions to conservative scoliosis treatment protocols and shed light on the development of multidisciplinary approaches in clinical practice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Adult Scoliosis Study Form, Diagnostic Test: Scoliosis graphy, Diagnostic Test: Visuel Aanalog Scale, Diagnostic Test: Adam's Test, Other: TRACE (Trunk Aesthetic Clinical Evaluation)Patients diagnosed with scoliosis deformity beginning in adulthood between the ages of 20 and 40 The scoliosis study form, consisting of clinical and radiological measurements of patients between the ages of 20 and 40 who have been diagnosed with scoliosis beginning in adulthood and who have applied to the scoliosis clinic, will be filled out in detail. Individuals included in the study group through randomization will receive both peloidotherapy and PSSE. |
| Control group | – | Diagnostic Test: Adult Scoliosis Study Form, Diagnostic Test: Scoliosis graphy, Diagnostic Test: Visuel Aanalog Scale, Diagnostic Test: Adam's Test, Other: TRACE (Trunk Aesthetic Clinical Evaluation)Patients diagnosed with scoliosis deformity beginning in adulthood between the ages of 20 and 40 The scoliosis study form, consisting of clinical and radiological measurements of patients between the ages of 20 and 40 who have been diagnosed with scoliosis beginning in adulthood and who have applied to the scoliosis clinic, will be filled out in detail. Individuals included in the control group through randomization will only receive PSSE. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study aims to investigate the effects of peloidotherapy combined with a Physiotherapeutic Scoliosis-Specific Exercise (PSSE) program on pain intensity, quality of life, and exercise adherence in patients with idiopathic scoliosis followed at the Scoliosis Clinic of the Department of Physical Medicine and Rehabilitation, Gaziosmanpaşa Training and Research Hospital. Patients scheduled for Barcelona Schroth-based PSSE will be recruited. Demographic data will be recorded. Participants will be randomized into study and control groups using the envelope method. Individuals aged 20-40 years, with a baseline VAS score ≥3 and pain lasting longer than three months, will be included. The study will be single-blinded, and outcomes will be assessed by a blinded evaluator.
Key inclusion criteria (7 listed)
- Aged 20-40 years
- Diagnosed with idiopathic scoliosis by a specialist physician
- Cobb angle between 15-40 degrees
- Able to perform PSSE exercises throughout the study period
- VAS ≥3 at the start of the study
Key exclusion criteria (7 listed)
- Individuals who have undergone scoliosis surgery
- Individuals with neuromuscular, congenital, or secondary scoliosis
- Individuals with rheumatological, inflammatory, or serious chronic diseases (such as cardiopulmonary insufficiency or kidney disease)
- Pregnant and breastfeeding women
- Conditions in which peloidotherapy is contraindicated (active skin infection, open wound, serious dermatological disease, history of allergic reaction, severe cardiopulmonary, kidney or liver failure, bleeding disorder or anticoagulant use, pregnancy/breastfeeding, and systemic infection)
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 |
|---|---|---|
| Adult Scoliosis Study FormThe adult scoliosis form, which includes demographic data, clinical and radiological measurements of patients aged 20-40 who present to the outpatient clinic with adult scoliosis, will be completed in detail. | Diagnostic test | Control group, Study Group |
| Scoliosis graphyPatients with results from the forward bending test and clinical evaluation consistent with scoliosis must have had a scoliosis X-ray taken within the last year. Coronal and sagittal balance; coronal and sagittal Cobb angles will be measured from posterior-anterior (PA) and lateral scoliosis radiographs. | Diagnostic test | Control group, Study Group |
| Visuel Aanalog ScalePain in adults with scoliosis will be assessed and recorded using the visual analog scale. Adults with scoliosis who report pain above VAS>3 will be included in the assessment. | Diagnostic test | Control group, Study Group |
| Adam's TestThe Adams test (forward bending test) (+) will be measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation- trunk rotation) measurements. Trunk rotation is a common component of scoliosis. It adds a twisting motion to the curvature of the spine. You can think of it like a spiral staircase turning upward. In scoliosis, the apical vertebra and vertebrae, which are the bones of the spine, can also twist, causing the ribs to twist with them. This bending is measured by the trunk rotation angle (trunk rotation angle or ATR). A higher ATR means that the bending of the body is more pronounced. The Cobb angle can be estimated using scoliometer measurements of the trunk rotation angle (ATR). | Diagnostic test | Control group, Study Group |
| TRACE (Trunk Aesthetic Clinical Evaluation)Aesthetic appearance is a primary consideration in the treatment of scoliosis. This has been clearly stated in a consensus by SOSORT experts, in which aesthetic improvement has become the main goal of scoliosis treatment.TRACE is based on four sub-scales: shoulders, scapulae and waist (which were already present in the AI), and the hemithorax. However, the scores for each sub-scale were changed with respect to AI: shoulders now ranged from 0-3, waist from 0-4, scapulae from 0-2 and hemithorax from 0-2. From these sub-scales we calculated TRACE, using the sum of the sub-scale scores to reach a 12-point scale | Other | Control group, Study Group |
Primary outcome
Adam's Test
Time frame: At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
The Adams test (forward bending test) (+) will be measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation- trunk rotation) measurements. Trunk rotation is a common component of scoliosis. It adds a twisting motion to the curvature of the spine. You can think of it like a spiral staircase turning upward. In scoliosis, the apical vertebra and vertebrae, which are the bones of the spine, can also twist, causing the ribs to twist with them. This bending is measured by the trunk rotation angle (trunk rotation angle or ATR). A higher ATR means that the bending of the body is more pronounced. The Cobb angle can be estimated using scoliometer measurements of the trunk rotation angle (ATR).
Visuel Aanalog Scale
Time frame: At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
Pain in adults with scoliosis will be assessed and recorded using the visual analog scale. Adults with scoliosis who report pain above VAS>3 will be included in the assessment. The Visual Analog Scale (VAS) is a subjective pain measurement tool where patients indicate the intensity of their pain by marking a point on a 10 cm (100 mm) horizontal line. The beginning of the line represents "no pain," and the end represents "the most severe pain imaginable." The marked point is measured between 0-10 cm (or 0-100 mm) and converted into a score, and is widely used in clinical pain assessment.
TRACE (Trunk Aesthetic Clinical Evaluation)
Time frame: At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
Aesthetic appearance is a primary consideration in the treatment of scoliosis. This has been clearly stated in a consensus by SOSORT experts, in which aesthetic improvement has become the main goal of scoliosis treatment.TRACE is based on four sub-scales: shoulders, scapulae and waist (which were already present in the AI), and the hemithorax. However, the scores for each sub-scale were changed with respect to AI: shoulders now ranged from 0-3, waist from 0-4, scapulae from 0-2 and hemithorax from 0-2. From these sub-scales we calculated TRACE, using the sum of the sub-scale scores to reach a 12-point scale
SRS-22r (Scoliosis Research Society Score)
Time frame: At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
The SRS-22r is a validated questionnaire intended to assess outcomes in patients with idiopathic scoliosis after spinal surgery. The first version, developed by the Scoliosis Research Society in 1999, had 24 items, and this was reduced to 22 items (accompanied by a name change) in the course of 3 major updates.The SRS-22 contains 22 questions covering 5 domains: function/activity 5 items; pain 5 items; self-perceived image 5 items; mental health 5 items; and satisfaction with treatment 2 items. Each item is scored from 1 (worst) to 5 (best). Each domain has a total sum score ranging from 5 to 25, except for satisfaction, which ranges from 2 to 10. The sum of the first 4 domains gives a maximum subtotal of 100, and when the satisfaction domain is included, the maximum total is 110
2 secondary outcomes
Questionnaire of Physiotherapeutic Specific Exercises of Scoliosis-QPSSE
Time frame: At the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
Beck Depression Inventory
Time frame: At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment
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 10 Jun 2026.
- Background: PubMed 40761866Jia K, Yang Y. Effect of acupuncture and massage on adolescent idiopathic scoliosis and pain severity. Front Med (Lausanne). 2025 Jul 21;12:1613800. doi: 10.3389/fmed.2025.1613800. eCollection 2025.
- Background: PubMed 33931829Karaarslan F, Yilmaz H, Akkurt HE, Gul S, Kardes S. Effectiveness of peloid therapy in patients with chronic low back pain: a single-blind controlled study. Int J Biometeorol. 2021 Nov;65(11):1799-1809. doi: 10.1007/s00484-021-02137-6. Epub 2021 May 1.
- Background: PubMed 26413145Schreiber S, Parent EC, Moez EK, Hedden DM, Hill D, Moreau MJ, Lou E, Watkins EM, Southon SC. The effect of Schroth exercises added to the standard of care on the quality of life and muscle endurance in adolescents with idiopathic scoliosis-an assessor and statistician blinded randomized controlled trial: "SOSORT 2015 Award Winner". Scoliosis. 2015 Sep 18;10:24. doi: 10.1186/s13013-015-0048-5. eCollection 2015.
- Background: PubMed 39459424Kyrkousis A, Iakovidis P, Chatziprodromidou IP, Lytras D, Kasimis K, Apostolou T, Koutras G. Effects of a Long-Term Supervised Schroth Exercise Program on the Severity of Scoliosis and Quality of Life in Individuals with Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial Study. Medicina (Kaunas). 2024 Oct 7;60(10):1637. doi: 10.3390/medicina60101637.
- Background: PubMed 38726971Dong H, You M, Li Y, Wang B, Huang H. Physiotherapeutic Scoliosis-Specific Exercise for the Treatment of Adolescent Idiopathic Scoliosis: A Systematic Review and Network Meta-analysis. Am J Phys Med Rehabil. 2024 Jan 1;104(1):14-25. doi: 10.1097/PHM.0000000000002524. Epub 2024 May 10.
- Background: PubMed 25780381Negrini S, Hresko TM, O'Brien JP, Price N; SOSORT Boards; SRS Non-Operative Committee. Recommendations for research studies on treatment of idiopathic scoliosis: Consensus 2014 between SOSORT and SRS non-operative management committee. Scoliosis. 2015 Mar 7;10:8. doi: 10.1186/s13013-014-0025-4. eCollection 2015.
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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.
Sinem Turkmen Ozoguz, MD principal investigator
Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
Deniz Oke, MD study chair
Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
Ebru Yilmaz Yalcinkaya, MD,Professor study director
Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Deformity and Adult Scoliosis, run by Gaziosmanpasa Research and Education Hospital 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 7 inclusion and 7 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 10 Jun 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 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?
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 Sinem Turkmen Ozoguz, MD (+90 554 820 47 69, turkmen_sinem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adam's Test (time frame: At the beginning (pre-treatment), at the end of the 10-session PSSE treatment (post-treatment), one month after the start of treatment, and three months after the start of treatment). The study lists 4 primary outcomes in all. 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 NCT07459400, which also lists 6 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 10 Jun 2026.