- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06959680
- Original Trial
The Effect of Kinesiotaping on Posture and Balance in Patients With Postural Thoracic Hyperkyphosis
Study Overview
Status
Intervention / Treatment
Detailed Description
In young adults, the thoracic kyphosis angle varies between 20-45◦ and 40◦ and above is defined as thoracic hyperkyphosis. The prevalence of thoracic hyperkyphosis is between 20-40% and is most commonly idiopathic . Thoracic hyperkyphosis is associated with back pain, limitation of movement-function, loss of balance, decreased quality of life and increased risk of falls. In the absence of pain or loss of function, especially young patients may present to improve cosmetic appearance. In the first stage of treatment, exercise, manual therapy, and in advanced stages, bracing and surgery can be applied . In treatment to reduce kyphosis, exercise is recommended at all ages and bracing is recommended in selected patients who do not respond to exercise. Multimodal combination therapies have been shown to be effective in young people . Kinesiobanding (KT) is an application that supports fascia, muscles and joints and reduces pain and inflammation . The combination of taping and exercise has been shown to have a positive effect on balance in hyperkyphotic adolescents. There is no study in the literature evaluating the effects of kinesiobanding on both balance parameters and kyphosis angle in young adults with thoracic hyperkyphosis. We think that favorable results can be obtained in the young age group with this study and our study may provide findings that kinesiobanting can be added to exercise therapy in routine treatment.
Sample Size of the Study: The sample size was determined by G-power analysis using the reference article. The number of participants to be included in the study was calculated as 16 patients for each group with G-power with a power of 95% and a type 1 error of 0.05 .
Patients will be divided into 3 groups. Taking into account the 20% loss rate that may occur during follow-up, a total of 48 patients were planned to be included in the study for 3 groups; 16 patients in each group.
TREATMENT GROUPS:
Group 1 (n=16)(E): exercise Group 2 (n=16)(E+KT): exercise + kinesio taping Group 3 (n=16)(E+SH): exercise + sham taping
The study groups will be determined according to the eligibility criteria among patients who present to the Physical Medicine and Rehabilitation outpatient clinic with complaints of posture disorder or nonspecific back pain and who have a thoracic kyphosis angle of 40 degrees or more on lateral radiography.
Cobb Angle Measurement:
Thoracic kyphosis angle will be measured on thoracic lateral radiograph. According to the literature, the gold standard measurement method is Cobb angle measurement; since the T4-T12 vertebra angle is less visible above the T4 vertebra level due to the superposition of other structures, the T4-T12 vertebra angle is used. The angle at the intersection point of the lines drawn parallel to the upper endplate of the T4 vertebra and the lower endplate of the T12 vertebra gives the Cobb angle . Patients with a Cobb angle of 40 and above and who do not have any additional disease to explain pain or hyperkyphosis will be included in the study.
Grouping of Participants, Patient Follow-up Form and Evaluations Our study was planned as a randomized single-blind prospective cohort, double-center study. Between 23/11/2024 - 23/08/2025 patients who meet the inclusion criteria among young adults aged 18-45 years who applied to Marmara University Faculty of Medicine and Sultan Abdulhamid Han Training and Research Hospital Physical Medicine and Rehabilitation outpatient clinics with complaints of nonspecific back pain or posture disorder will be included in the study. The study is planned to last 9 months.
Cobb angle measurement on thoracic lateral radiograph, kyphosis angle and index measurement with Flexicurve device, Biodex device, VAS scoring, Berg balance scale, SRS-22 questionnaire, International Physical Activity Questionnaire (Short) (IPAQ) will be used in the study.
Informed consent: After the patients are verbally informed, consent forms will be given to the patients in which the purpose of the study is clearly explained and they will be asked to sign the forms.
Exercise Program (1st group=E group) The exercises were designed as a 4-week home program. In all three groups, the exercises will be performed once a day, 3 days a week, one day apart, for 4 weeks.
Each exercise will be performed with 10 repetitions in the first two weeks and 15 repetitions in the third and fourth weeks, with 5 sec contraction and 5 sec relaxation, with a 1 min break between two different exercises.
In the first stage, home exercises will be demonstrated to the patients. Afterwards, all patients will be given a pictorial exercise brochure and an exercise diary; patients will be encouraged to comply with the treatment with weekly phone calls.
In postural thoracic hyperkyphosis, strengthening, stretching exercises and breathing exercises will be given for the most affected muscle groups. Posture exercises were planned for trapezius, lattismus dorsi, levator scapula, rhomboids, serratus posterior-superior-inferior, longissimus thoracis, spinalis thoracis, iliocostalis thoracis, semispinalis thoracis, multifidus, rotatores thoracis, diaphragm, intercostal externi, abdominal muscles:
- Thoracic and shoulder girdle strengthening exercises
- Pelvic and lumbar stabilization exercises
- Anterior and lateral abdominal muscle strengthening exercises
- Hip flexor stretching exercises
- Lumbar extensor stretching exercises
- Breathing exercises Kinesio Taping (2nd Group= E+KT Group) Kinesiobant will first be tested on a small area of the forearm and treatment will be discontinued if allergy develops. Taping will be applied with the patient in upright posture and shoulders in retraction. From the level of the acromioclavicular joint, the first 5 cm will be applied without stretching, then maximum stretching will be applied, moving to the diagonal and ending at the lower border of the costa, the adhesion point will be adhered without stretching. The same process will be applied on the opposite side and a total of two I-shaped bands will be used to create an X-shape on the back. The crossing point of the bands will be adjusted to the lower 1/3 of the medial edge of the scapula. Taping will be performed after all initial measurements (T0) and will be renewed weekly (on days 0, 7, 14, 21). At the end of the 1st month, i.e. on day 28 (T1), the last measurements will be made with the kinesio tape and then the tape will be removed. One month after the end of the treatment, the patient will be called again (T2) and final measurements will be made without the tape.
Sham Taping (3rd group= E+SH group) Sham taping treatment will be performed to exclude the biofeedback effect of taping and to distinguish its functional effect. The patch to be used in sham taping will first be tested on a small area of the forearm and if allergy develops, the treatment will be terminated. Taping will be applied with the patient in upright posture and shoulders in retraction. Skin color, elasticity and non-stretchable plaster of the same color as the skin will be used. From the level of the acromioclavicular joint, it will be applied from the level of the acromioclavicular joint to the diagonal without stretching and will be adhered to the adhesion point without stretching, ending at the lower border of the costa. The same procedure will be applied to the opposite side and an X shape will be formed on the back using a total of two I-shaped plasters. The crossing point of the bands will be adjusted to the lower 1/3 of the medial edge of the scapula. Taping will be performed after all initial measurements (T0) and will be renewed weekly (on days 0, 7, 14, 21). At the end of the 1st month, i.e. on day 28 (T1), the last measurements will be made with the patch and then the tape will be removed. One month after the end of the treatment, the patient will be called again (T2) and final measurements will be made without the tape.
Kyphosis Angle Measurement with Flexicurve:
At the beginning of the study,at the end of treatment (1st month) and 1 month after the end of treatment (2nd month).The Flexicurve ruler (Staedtler Mars Inc, Nurnberg, Germany),which is a plastic-coated bendable metal band approximately 60 cm long,will be used for the measurements.The ruler bends in only one direction and retains its shape when bent.The patient will stand as upright as possible and the spinous process of the seventh cervical vertebra(C7)and the upper part of the sacrum(S1)will be palpated and marked.The Flexicurve ruler will be placed along the C7-S1 vertebrae to form the shape of the spine,then the ruler will be placed flat on the paper and the lines transferred onto the paper.A vertical line will be drawn to connect the C7 and S1 landmarks.The intersection of this line with the spinal curve previously drawn with the flexicurve ruler will mark the transition between the thoracic and lumbar curves.A straight line drawn between C7 and the intersection point will be recorded as the thoracic kyphosis length (TL) in cm.Thoracic width (TW)will be recorded in cm as the length of the perpendicular line drawn from the apex of the kyphosis to TL.Kyphosis index will be calculated with the formula:(TL/TW) x 100.All measurements will be performed by two different specialists,repeated 2 times each and averaged.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Feyza Nur Yücel, Specialist
- Phone Number: +90 0216 542 20 00
- Email: dr.fny28@gmail.com
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Recruiting
- Marmara University Faculty of Medicine
-
Contact:
- Gökçenur Yalçın, Specialist
- Phone Number: 0216 777 55 01
- Email: gokce_cihaner@hotmail.com
-
Principal Investigator:
- Yeliz Bahar Özdemir, Asst. Prof.
-
-
Üsküdar
-
Istanbul, Üsküdar, Turkey (Türkiye)
- Recruiting
- Sultan 2.Abdülhamid Han Training and Research Hospital
-
Contact:
- Feyza Nur Yücel, Specialist
- Email: dr.fny28@gmail.com
-
Principal Investigator:
- Melike Ünsal Küçük, Medical Doctor
-
Sub-Investigator:
- Emre Ata, Asst. Prof.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between the ages of 18-45
- Among the patients who applied to the physical medicine and rehabilitation outpatient clinic with poor posture or nonspecific back pain, the kyphosis angle was measured as ≥ 40 on the thoracic lateral radiograph
- Being literate
- Agreeing to participate in the research
Exclusion Criteria:
- Patients younger than 18 years and older than 45 years
- Spinal deformity, Scheuermann disease, disc herniation
- Previous spine surgery and trauma
- Neuromuscular, peripheral neuropathic disease
- Pregnant and postmenopausal women
- Vertigo disease (central or peripheral cause)
- Use of medication that may cause dizziness (in the last 3 months)
- Defect of vision
- Presence of physical deformity or additional disease that will prevent exercise
- Active skin disease in the area where tape will be applied
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1 Exercise
Group 1 participants will receive exercise therapy alone.
|
only exercise will be performed without any band treatment
|
|
Active Comparator: Group 2 Exercise and Kinesiotaping
Group 2 participants will receive exercise and kinesiotaping treatment.
|
Exercise and Kinesiotaping
|
|
Sham Comparator: Group 3 Exercise and Shamtaping
Group 3 participants will receive exercise and shamtaping treatment.
|
exercise and sham banding (banding without tension with plaster)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thoracic hyperkyphosis angle (Kyphosis Angle Measurement with Flexicurve)
Time Frame: 9 months
|
They will be performed at the beginning of the study, at the end of treatment (1st month) and 1 month after the end of treatment (2nd month). Kyphosis index will be calculated with the formula: (TL/TW) x 100. Higher indices will indicate higher degrees of kyphosis. All measurements will be performed by two different specialists, repeated 2 times each and averaged. (How to measure is explained in detail in the 'detailed description' section). |
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static and Dynamic Balance Measurement with Biodex Device
Time Frame: 9 months
|
Balance measurement of the patients will be performed with the Biodex Balance System SD (Biodex, Inc, Shirley, NY) (BBS).
BBS is a movable circular platform that can move in antero-posterior and medio-lateral axes.
In our study; bilateral stance static postural stability test (level 12, stable platform), bilateral stance dynamic postural stability test (level 4, unstable platform), single leg stance postural stability test (stable platform) and stability limit test will be measured.
The postural stability measurement includes the overall stability index (OSI), anteroposterior stability index (APSI) and mediolateral stability index (MLSI).
High values in these scores indicate poor balance.
All balance tests will be performed with eyes open and barefoot and repeated 3 times with a 10-second rest interval.
|
9 months
|
|
Vas (Visual Analog Scale) Scoring
Time Frame: 9 months
|
It will be evaluated before and at the end of treatment and at the end of the 2nd month and the patient will be asked to mark the degree of pain on a linear line with a value between 0-10.
|
9 months
|
|
Berg Balance Scale (Turkish)
Time Frame: 9 months
|
The scale consists of 14 predetermined tasks, each task achievement is scored between 0-4, and will be performed 3 times: before treatment, at the end of the 1st month and at the end of the 2nd month.
|
9 months
|
|
SRS-22 (Turkish)
Time Frame: 9 months
|
The SRS-22 questionnaire, which was developed by the Scoliosis Research Society (SRS) to be used in spinal curvatures and whose Turkish validity and reliability has been proven, will be filled out by patients before, at the end of treatment and at the 2nd month control.
|
9 months
|
|
International Physical Activity Questionnaire (Short) (IPAQ)
Time Frame: 9 months
|
This questionnaire, the Turkish version of which has reliability and validity in assessing physical activity, will be completed by patients before, at the end and at 2 months of treatment to obtain information about their physical activity in daily life.
|
9 months
|
Collaborators and Investigators
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Dissection, Blood Vessel
- Acute Aortic Syndrome
- Bone Diseases
- Musculoskeletal Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Spinal Diseases
- Aortic Diseases
- Aneurysm
- Spinal Curvatures
- Aortic Dissection
- Kyphosis
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- 09.2024.256
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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