The Effect of Peloidotherapy in Young Adults Undergoing Physical Therapy Scoliosis Specific Exercises (PSSE)

NCT07459400 | Not Yet Recruiting

• 1 other identifier: 22.01.2026-139
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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..

Conditions

Spine Deformity; Adult Scoliosis; Peloidotherapy

Keywords

Peloidotherapy; Adult Scoliosis; Physiotherapy Scoliosis-Specific Exercises (PSSE); Pain; Quality of Life

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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

  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

  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

  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

  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

Study Arms (2)

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.

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.

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)

Interventions

Adult Scoliosis Study Form DIAGNOSTIC_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.

Control group; Study Group

Scoliosis graphy DIAGNOSTIC_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.

Control group; Study Group

Visuel Aanalog Scale DIAGNOSTIC_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.

Control group; Study Group

Adam's Test DIAGNOSTIC_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).

Control group; Study Group

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

Control group; Study Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Aged 20-40 years
• Diagnosed with idiopathic scoliosis by a specialist physician
• Cobb angle between 20-40 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 40761866 BACKGROUND

• 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.

  PMID: 33931829 BACKGROUND

• 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.

  PMID: 26413145 BACKGROUND

• 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.

  PMID: 39459424 BACKGROUND

• 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.

  PMID: 38726971 BACKGROUND

• 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.

  PMID: 25780381 BACKGROUND

MeSH Terms

Conditions

Scoliosis; Pain

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sinem Turkmen Ozoguz, MD

  Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department

  PRINCIPAL INVESTIGATOR

• Deniz Oke, MD

  Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department

  STUDY CHAIR

• Ebru Yilmaz Yalcinkaya, MD,Professor

  Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department

  STUDY DIRECTOR

• Serap Seringec Karabulut, MD

  Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department

  STUDY CHAIR

Central Study Contacts

Sinem Turkmen Ozoguz, MD

CONTACT

+90 554 820 47 69; turkmen_sinem@hotmail.com

Deniz Oke, MD

CONTACT

+90 532 430 69 50; dr_denizoke@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: March 9, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): October 23, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-02

Locations

TU (1)