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Clinical Trials/NCT07348939
NCT07348939
Completed
Not Applicable

Effect Of Kinesiology Tape On Pain, Posture, Balance And Respiration In Ankylosing Spondylitis

Bursa Yuksek Ihtisas Training and Research Hospital1 site in 1 country63 target enrollmentStarted: April 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Bursa Yuksek Ihtisas Training and Research Hospital
Enrollment
63
Locations
1
Primary Endpoint
Fingertips-Floor Distance

Overview

Brief Summary

This study will investigate the effects of kinesio taping on pain, posture, balance, and respiration in ankylosing spondylitis, and compare its effects with routine home exercises given to this group.

Detailed Description

Patients over 18 years of age with a stable course of ankylosing spondylitis will be included in the study. Patients will be randomly divided into two groups using a random number table. The first group will receive a home exercise program (range of motion[ROM], spinal extensor strengthening, posture, balance, and breathing exercises), while the second group will receive both the home exercise program and kinesio taping. Subsequently, comparisons will be made between the groups using visual analog scale (VAS), ROM (cervical and lumbar), Berg Balance Scale, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath AS Metrology Index (BASMI), Modified Schober test, hand-finger-ground distance, chest expansion, and AS(Ankylosing Spondiliytis) quality of life questionnaire.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Kinesio Tape(Group1)

Experimental

The first group will receive both a home exercise program (ROM, spinal extensor strengthening, posture, balance and breathing exercises) and kinesio taping.

Intervention: Kinesio Taping (Procedure)

Kinesio Tape(Group1)

Experimental

The first group will receive both a home exercise program (ROM, spinal extensor strengthening, posture, balance and breathing exercises) and kinesio taping.

Intervention: Exercise (Procedure)

Exercise(Group 2)

Active Comparator

The second group consists only of a home exercise program (ROM, spinal extensor strengthening, posture, balance and breathing exercises).

Intervention: Exercise (Procedure)

Outcomes

Primary Outcomes

Fingertips-Floor Distance

Time Frame: From enrollment to the end of treatment at 6 weeks

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.

Modified Schober Test Score

Time Frame: From enrollment to the end of treatment at 6 weeks

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.

BASDAI Score

Time Frame: From enrollment to the end of treatment at 6 weeks

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.

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.

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).

AS Health Assessment Questionnaire

Time Frame: From enrollment to the end of treatment at 6 weeks

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.

Chest Expanison Diameter

Time Frame: From enrollment to the end of treatment at 6 weeks

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.

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

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.

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.

Nocturnal Spinal Pain

Time Frame: From enrollment to the end of treatment at 6 weeks

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.

Berg Balance Scale

Time Frame: From enrollment to the end of treatment at 6 weeks

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Bursa Yuksek Ihtisas Training and Research Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Busra Gokgun

Principal Investigator

Bursa Yuksek Ihtisas Training and Research Hospital

Study Sites (1)

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