- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07428083
Effect of Kinesio Taping Combined With Schroth Therapy in Young Adults With Idiopathic Scoliosis
Comparison of Schroth Therapy and Kinesiotaping in Lower Back and Back Pain in Young Adults With Idiopathic Scoliosis: A Double-Blind Placebo-Controlled Randomized Study
In this study, the effects of Kinesio Taping methods applied in combination with Schroth therapy on pain and functional capacity in young adults diagnosed with idiopathic scoliosis will be evaluated.
This study is designed as a randomized controlled trial. Participants will be randomly assigned to one of three groups:
Group 1: Schroth therapy combined with Kinesio Taping
Group 2: Schroth therapy alone
Group 3: Schroth therapy combined with sham Kinesio Taping
Kinesio Taping will be applied for 4 weeks. The tape will remain in place for 5 consecutive days, followed by a 2-day rest period for the skin, and this cycle will be repeated throughout the intervention period.
Schroth therapy will be administered 3 times per week for 4 weeks.
Assessments will be conducted at baseline (Week 0), during treatment (Week 2), at the end of treatment (Week 4), and at follow-up (Week 8).
The primary outcome measures will be pain intensity assessed by the Numeric Rating Scale (NRS) and functional disability assessed by the Oswestry Disability Index (ODI). Secondary outcome measures will include the Scoliosis Research Society-22 (SRS-22) questionnaire and the Patient Global Impression of Change (PGIC) scale.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to evaluate the effects of Schroth therapy and the addition of Kinesio Taping on pain, functional capacity, and quality of life in young adults with idiopathic scoliosis who were diagnosed during adolescence and currently experience back pain.
Adolescent idiopathic scoliosis (AIS) is a spinal deformity of unknown origin that develops during adolescence, with a worldwide prevalence of 1-3%. The current clinical gold standard for diagnosing scoliosis is the measurement of the Cobb angle on standing posteroanterior radiographs. The Cobb angle determines the severity classification of AIS; a Cobb angle of ≥40° indicates a severe deformity that may require surgical intervention, whereas lower angles are typically managed with non-surgical treatment approaches.
Individuals aged 18-30 years are often described as having "young adult idiopathic scoliosis" (YAIS). Even if they received successful conservative treatment during adolescence, these individuals may present in adulthood with pain, progression of deformity, and cosmetic concerns. The development of symptoms in this age group increases the need for treatment, and evaluating the effectiveness of interventions applied during this period is clinically meaningful.
The original Schroth exercises were developed in the early 20th century by Katharina Schroth. This exercise-based approach focuses on corrective breathing techniques and postural adjustments to address three-dimensional spinal deformities.
Kinesio Taping (KT) is a conservative treatment method that has gained popularity in recent years for managing musculoskeletal conditions and controlling pain. This technique was first described by Kenzo Kase.
Since an evidence-based treatment algorithm for managing back pain in patients with idiopathic scoliosis has not yet been clearly established, clinicians often select treatment methods based on preference. Common approaches include home exercise programs, physical therapy, pharmacological treatment (such as acetaminophen, non-steroidal anti-inflammatory drugs, muscle relaxants, or opioid analgesics), back school programs, and spinal manipulation.
Both Schroth therapy and Kinesio Taping are non-invasive and conservative treatment methods commonly used in patients with idiopathic scoliosis.
Although international studies have evaluated the effectiveness of Schroth therapy and Kinesio Taping separately, and some have explored combined applications, randomized controlled trials including a Schroth therapy group, a combined Schroth + Kinesio Taping group, and a sham taping control group in adult individuals are limited or absent in the national literature.
The distinguishing aspect of this study is the controlled and comparative evaluation of the combination of Schroth therapy and Kinesio Taping, rather than assessing each method in isolation. Additionally, the inclusion of a sham taping group allows consideration of potential placebo effects.
The findings of this study are expected to contribute to the evidence-based use of non-invasive treatment approaches in the management of idiopathic scoliosis
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Şevval Çakmakcı Alkayış, MD
- Phone Number: +905556455465
- Email: sevvalcakmakci@outlook.com
Study Contact Backup
- Name: Ozge G İlleez, MD
- Phone Number: +905326255684
- Email: ozgeilleez@hotmail.com
Study Locations
-
-
Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34752
- Fatih Sultan Mehmet Training and Research Hospital
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Principal Investigator:
- Şevval Çakmakcı Alkayış, MD
-
Sub-Investigator:
- Özge G İlleez, MD
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged between 18 and 30 years.
- Radiologically confirmed diagnosis of idiopathic scoliosis.
- Cobb angle between 10° and 30° and considered candidates for conservative treatment.
- Risser stage 5.
- History of low back or back pain within the last 3 months (defined as NRS ≥ 4).
- No acute orthopedic or neurological condition that would prevent participation in physical exercise interventions.
- Willingness to participate voluntarily and provide written informed consent.
- Ability to attend treatment sessions regularly throughout the study period.
Exclusion Criteria:
- Diagnosis of non-structural (functional) scoliosis, congenital scoliosis, or neuromuscular scoliosis.
- History of previous spinal surgery.
- Participation in scoliosis-specific exercise therapy within the last 6 months.
- Presence of open wounds, dermatological conditions, or allergy to taping materials.
- History of psychiatric disorders or neurological diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Schroth Therapy + Kinesio Taping
Participants in this group will receive Schroth therapy three times per week for 4 weeks combined with Kinesio Taping.
The tape will be applied for 5 consecutive days followed by a 2-day rest period, and this cycle will be repeated for 4 weeks.
|
Schroth therapy is a scoliosis-specific exercise program designed to address three-dimensional spinal deformities.
The intervention includes individualized corrective exercises, rotational angular breathing techniques, postural alignment training, trunk muscle stabilization, and muscular symmetry exercises.
Sessions will be supervised by a certified physiotherapist three times per week for 4 weeks.
Kinesio Taping will be applied using elastic therapeutic tape with corrective tension techniques targeting spinal alignment and paraspinal muscle facilitation.
The tape will remain in place for 5 consecutive days followed by a 2-day rest period.
This cycle will be repeated throughout the 4-week intervention period.
|
|
Active Comparator: Schroth Therapy Alone
Participants in this group will receive Schroth therapy three times per week for 4 weeks without any taping intervention.
|
Schroth therapy is a scoliosis-specific exercise program designed to address three-dimensional spinal deformities.
The intervention includes individualized corrective exercises, rotational angular breathing techniques, postural alignment training, trunk muscle stabilization, and muscular symmetry exercises.
Sessions will be supervised by a certified physiotherapist three times per week for 4 weeks.
|
|
Sham Comparator: Schroth Therapy + Sham Kinesio Taping
Participants in this group will receive Schroth therapy three times per week for 4 weeks combined with sham Kinesio Taping.
The sham tape will be applied without therapeutic tension and following a non-corrective technique.
The application schedule will be identical to the experimental taping group (5 days on, 2 days off for 4 weeks).
|
Schroth therapy is a scoliosis-specific exercise program designed to address three-dimensional spinal deformities.
The intervention includes individualized corrective exercises, rotational angular breathing techniques, postural alignment training, trunk muscle stabilization, and muscular symmetry exercises.
Sessions will be supervised by a certified physiotherapist three times per week for 4 weeks.
Sham Kinesio Taping will be applied using elastic therapeutic tape without therapeutic tension and without corrective technique.
The tape will be placed in a non-corrective manner that does not aim to influence spinal alignment or muscle facilitation.
The application schedule will be identical to the experimental taping group (5 days on, 2 days off for 4 weeks) to maintain participant blinding.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Intensity (NRS)
Time Frame: Baseline (Week 0), Week 2, Week 4, and Week 8
|
Pain intensity will be assessed using the Numeric Rating Scale (NRS), scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Changes in pain intensity will be evaluated across all assessment time points during the study
|
Baseline (Week 0), Week 2, Week 4, and Week 8
|
|
Change in Functional Disability (ODI)
Time Frame: Baseline (Week 0), Week 4, and Week 8
|
Functional disability will be assessed using the Oswestry Disability Index (ODI), a validated questionnaire designed to measure disability related to low back pain.
The ODI consists of 10 items evaluating daily living activities, with higher scores indicating greater disability.
Changes in functional disability will be evaluated across the specified assessment time points.
|
Baseline (Week 0), Week 4, and Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Scoliosis-Specific Quality of Life (SRS-22)
Time Frame: Baseline (Week 0), Week 4, and Week 8
|
Quality of life will be assessed using the Scoliosis Research Society-22 (SRS-22) questionnaire, a scoliosis-specific, validated instrument that evaluates function/activity, pain, self-image, mental health, and satisfaction with management.
Higher scores indicate better health-related quality of life.
Changes in SRS-22 scores will be evaluated across the specified assessment time points.
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Baseline (Week 0), Week 4, and Week 8
|
|
Patient Global Impression of Change (PGIC)
Time Frame: Week 2, Week 4, and Week 8
|
Global perceived improvement will be assessed using the Patient Global Impression of Change (PGIC) scale, a patient-reported outcome measure evaluating overall change in condition following treatment.
The PGIC is a 7-point scale ranging from "very much worse" to "very much improved."
|
Week 2, Week 4, and Week 8
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
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
Other Study ID Numbers
- KNS-SCHRT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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