NCT07348939

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

December 14, 2025

Last Update Submit

January 10, 2026

Conditions

Keywords

Ankylosing SpondylitisKinesio TapingExercise

Outcome Measures

Primary Outcomes (12)

  • VISUAL ANALOG SCALA

    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.

    From enrollment to the end of treatment at 6 weeks

  • Spinal Pain

    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.

    From enrollment to the end of treatment at 6 weeks

  • Nocturnal Spinal Pain

    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.

    From enrollment to the end of treatment at 6 weeks

  • Fingertips-Floor Distance

    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.

    From enrollment to the end of treatment at 6 weeks

  • Modified Schober Test Score

    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.

    From enrollment to the end of treatment at 6 weeks

  • BASDAI Score

    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.

    From enrollment to the end of treatment at 6 weeks

  • BASFI Score

    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

  • BASMI Score

    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).

    From enrollment to the end of treatment at 6 weeks

  • AS Health Assessment Questionnaire

    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.

    From enrollment to the end of treatment at 6 weeks

  • Chest Expanison Diameter

    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.

    From enrollment to the end of treatment at 6 weeks

  • Respiratory Function Test (RFT)

    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

  • Berg Balance Scale

    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

Study Arms (2)

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.

Procedure: Kinesio TapingProcedure: Exercise

Exercise(Group 2)

ACTIVE COMPARATOR

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

Procedure: Exercise

Interventions

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.

Kinesio Tape(Group1)
ExercisePROCEDURE

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.

Exercise(Group 2)Kinesio Tape(Group1)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years of age, who had been diagnosed with ankylosing spondylitis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Yildirim, 16310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylitis, AnkylosingMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomly assigned to two groups using a random number table; the first group will receive a home exercise program (ROM, spinal extensor strengthening, posture, balance, and breathing exercises), while the second group will receive both the home exercise program and kinesio taping.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 14, 2025

First Posted

January 16, 2026

Study Start

April 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 30, 2024

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 3 months and ending 2 years after the publication of results
Access Criteria
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Locations