- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07348939
Effect Of Kinesiology Tape On Pain, Posture, Balance And Respiration In Ankylosing Spondylitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Yildirim
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Bursa, Yildirim, Turkey (Türkiye), 16310
- Bursa Yuksek Ihtisas Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients over 18 years of age, who had been diagnosed with ankylosing spondylitis
Exclusion Criteria:
Patients with
- active malignancies
- active cellulitis and any infections,
- open wounds
- deep vein thrombosis
- any chronic pulmonary disease,
- fever of unknown origin
- carotid arterial disease,
- vestibular and orthopedic pathologies, affecting balance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kinesio Tape(Group1)
The first group will receive both a home exercise program (ROM, spinal extensor strengthening, posture, balance and breathing exercises) and kinesio taping.
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Kinesiology tapes were applied when the patient was in forward flexion and shoulders were protracted, using functional correction method.
Applied without tension at the adhesion point, without any tension in the first 5 from acromioclavicular joint level and then by applying maximum tension and terminating at the lower boundary of costa.
Crossing point of the tapes was arranged to be at the lower 1/3 of scapula medial side.
Muscle stimulation technique was used to support diaphragm muscle.
Origo was xiphoid process, cartilage of 6th costa and lumbar vertebra and insertio was central tendon.
Application was made when the patient was standing, with spine at hyperextension, in inspiration and arms in abduction.
Tape was applied by following the lower costa curvature from xiphoid process towards lateral.
Symmetrically, kinesiology tape was applied dorsally, starting from T12 level and following lower costa curvature.
Conventional exercises (Joint ROM, spinal extensor strengthening, posture, balance and respiratory exercises) were explained verbally to both groups and video demonstrations were shown.
Patients exercised five days a week for six week, in three sets, consisting of 10 repetitions per day.
Exercise practices of the patients were routinely monitored and the patients were encouraged to continue exercise program and phone calls were made to follow-up exercises.
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Active Comparator: Exercise(Group 2)
The second group consists only of a home exercise program (ROM, spinal extensor strengthening, posture, balance and breathing exercises).
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Conventional exercises (Joint ROM, spinal extensor strengthening, posture, balance and respiratory exercises) were explained verbally to both groups and video demonstrations were shown.
Patients exercised five days a week for six week, in three sets, consisting of 10 repetitions per day.
Exercise practices of the patients were routinely monitored and the patients were encouraged to continue exercise program and phone calls were made to follow-up exercises.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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VISUAL ANALOG SCALA
Time Frame: From enrollment to the end of treatment at 6 weeks
|
This is a scale used to assess pain.
It consists of numbered lines on a horizontal line from 0 to 10.
The patient marks the line to indicate the intensity of the pain they feel.
0 corresponds to no pain, and 10 corresponds to the most severe pain.
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From enrollment to the end of treatment at 6 weeks
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Spinal Pain
Time Frame: From enrollment to the end of treatment at 6 weeks
|
The device consists of numbered boxes on a horizontal line from 0 to 10.
The patient marks the boxes to indicate the spinal pain they have felt in the last week.
0 corresponds to no pain, and 10 corresponds to the most severe pain.
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From enrollment to the end of treatment at 6 weeks
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Nocturnal Spinal Pain
Time Frame: From enrollment to the end of treatment at 6 weeks
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The system consists of numbered boxes on a horizontal line from 0 to 10.
The patient marks the boxes to indicate the nocturnal spinal pain they have felt in the past week.
0 corresponds to no pain, and 10 corresponds to the most severe pain.
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From enrollment to the end of treatment at 6 weeks
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Fingertips-Floor Distance
Time Frame: From enrollment to the end of treatment at 6 weeks
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The patient is asked to stand upright and touch the tip of their finger to the ground without bending their knees.
If there is a limitation, the distance between the fingertip and the ground is measured and recorded.
For men, up to 10 cm is considered normal.
For women, it is zero.
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From enrollment to the end of treatment at 6 weeks
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Modified Schober Test Score
Time Frame: From enrollment to the end of treatment at 6 weeks
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While the patient is standing, a mark is made 10 cm upwards and 5 cm downwards from this prominence.
The distance between the two points is 15 cm.
The patient performs maximum flexion of their torso.
The distance between the two points is measured.
15 cm is subtracted from the measured distance to find the difference.
If the difference is less than 5 cm, the test is positive.
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From enrollment to the end of treatment at 6 weeks
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BASDAI Score
Time Frame: From enrollment to the end of treatment at 6 weeks
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This is a disease activity-related scale.
It consists of 6 questions.
Each question has horizontally numbered boxes from 0 to 10, where 0 means none and 10 means very severe.
The patient should answer the questions based on their condition over the past week.
The questions cover: weakness/fatigue, neck/back/hip pain, joint pain and swelling, touch and pressure sensitivity, and the severity and duration of morning stiffness.
The average of the answers to 2 questions related to morning stiffness is added to the sum of the first 4 questions, and then divided by 5 to obtain a combined score.
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From enrollment to the end of treatment at 6 weeks
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BASFI Score
Time Frame: From enrollment to the end of treatment at 6 weeks
|
The purpose of this scale is to determine and monitor physical functioning in patients with AS.
It consists of 10 questions in total: 8 items related to the patients' functional anatomy (bending, reaching, changing position, standing, turning, and climbing stairs) and 2 items assessing the patients' skills related to daily living.
The scale is numbered horizontally in rows from 0 to 10, where 0 means easy and 10 means impossible.
|
From enrollment to the end of treatment at 6 weeks
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BASMI Score
Time Frame: From enrollment to the end of treatment at 6 weeks
|
BASMI is a scale used to measure axial skeletal mobility in AS patients and to objectively evaluate clinically significant changes in spinal movement.
It was first introduced in 1994 as a 2-point scale.
A year later, it was adapted as a 10-point scale, and more recently, its current version as a linear marker has been developed and validated through validation studies.72
It consists of 5 items representing clinical measurements of cervical rotation, tragus-to-wall distance, lumbar flexion (modified Schober), spinal lateral flexion, and maximal intermalleolar distance.
Each item is scored between 0 and 10 according to separately defined cut-off values.
The ranges are defined as cervical rotation (8.5°-85.0°),
tragus-to-wall (10 cm-38 cm), lumbar flexion (7.0 cm-0.7 cm), lumbar lateral flexion (1.2 cm-20 cm), and intermalleolar distance (30 cm-120 cm).
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From enrollment to the end of treatment at 6 weeks
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AS Health Assessment Questionnaire
Time Frame: From enrollment to the end of treatment at 6 weeks
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This test is used to assess the physical function of an individual with AS.
It consists of 20 questions across 8 categories: dressing, lying down, standing up, eating, walking, hygiene, daily tasks, and grasping.
Patients should answer the questions considering their performance over the past week.
A scoring system from 0 to 3 is used, with 4 options: 0; easily able, 3; unable to do at all.
The total score is divided by the number of questions answered to obtain the final value.
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From enrollment to the end of treatment at 6 weeks
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Chest Expanison Diameter
Time Frame: From enrollment to the end of treatment at 6 weeks
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The patient is asked to perform maximal inspiration and expiration.
During this time, a measurement is taken and recorded at the 4th intercostal space.
The difference between these two results, both in centimeters, is calculated to obtain the desired value.
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From enrollment to the end of treatment at 6 weeks
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Respiratory Function Test (RFT)
Time Frame: From enrollment to the end of treatment at 6 weeks
|
It is a physiological test that measures airflow as a function of the volume of air taken in and exhaled during respiration and time. Today, it is one of the most basic diagnostic methods frequently used in the diagnosis and monitoring of many lung diseases. Dynamic Spirometry It is the first step in respiratory function tests. It is used to evaluate ventilatory capacity. The most important cause of impaired ventilatory capacity is airway obstruction. It is evaluated during forced inspiration and expiration. The measured volume is related to time and expressed with volume-time or flow-volume curves. FORCED VITAL CAPACITY (FVC): The volume of air expelled with a forced, rapid, and deep expiration after a deep inspiration. Normal: FVC = VC(Vital capacity) Airway obstruction: FVC < VC Normally, 75-80% of the volumes are expelled in the first second. It generally reflects the large airways. It is significantly red |
From enrollment to the end of treatment at 6 weeks
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Berg Balance Scale
Time Frame: From enrollment to the end of treatment at 6 weeks
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The Berg Balance Scale is a test used to assess functional balance. It was developed in 1989 by Katherine Berg to evaluate balance functions in the elderly. The scale is useful in predicting the risk and consequences of falls, in evaluating rehabilitation in hospitalized patients, and in assessing the length of hospital stay. It consists of 14 items for performance evaluation. Each item is scored between 0 and 4 according to the patient's ability to meet the distance and time requirements of the test. A score of 4 indicates the ability to complete the task without assistance. The highest score is 56. Scores between 0 and 20 indicate impaired balance, 21-40 indicate acceptable balance, and 41-56 indicate good balance. |
From enrollment to the end of treatment at 6 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
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
- Axial Spondyloarthritis
- Bone Diseases
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Spinal Diseases
- Spondylarthropathies
- Ankylosis
- Spondylarthritis
- Spondylitis
- Behavior
- Spondylitis, Ankylosing
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- 2011-KAEK-25 2023/03-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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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