- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07459400
The Effect of Peloidotherapy in Young Adults Undergoing Physical Therapy Scoliosis Specific Exercises (PSSE)
The Effect of Peloidotherapy on Pain and Quality of Life in Young Adult Individuals With Scoliosis Undergoing Physiotherapy Scoliosis-Specific Exercises (PSSE)
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Deniz Oke, MD
- Phone Number: +90 532 430 69 50
- Email: dr_denizoke@hotmail.com
Study Contact Backup
- Name: Sinem Turkmen Ozoguz, MD
- Phone Number: +90 554 820 47 69
- Email: turkmen_sinem@hotmail.com
Study Locations
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Gaziosmanpasa
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Istanbul, Gaziosmanpasa, Turkey (Türkiye), 34255
- Recruiting
- Gaziosmanpasa Training and Research Hospital
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Contact:
- Deniz Oke, MD
- Phone Number: +90 532 430 69 50
- Email: dr_denizoke@hotmail.com
-
Contact:
- Sinem Turkmen Ozoguz, MD
- Phone Number: +90 554 820 47 69
- Email: turkmen_sinem@hotmail.com
-
Sub-Investigator:
- Serap Seringec Karabulut, MD
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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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.
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.
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 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).
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
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|
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.
|
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.
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.
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 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).
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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
|
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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
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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.
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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
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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
|
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
|
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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
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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
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
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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
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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
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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
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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
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Collaborators and Investigators
Investigators
- Study Director: Ebru Yilmaz Yalcinkaya, MD,Professor, Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
- Principal Investigator: Sinem Turkmen Ozoguz, MD, Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
- Study Chair: Deniz Oke, MD, Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
- Study Chair: Serap Seringec Karabulut, MD, Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
Publications and helpful links
General Publications
- Schreiber 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.
- 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.
- Karaarslan 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.
- Kyrkousis 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.
- Dong 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.
- Negrini 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22.01.2026-139
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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