Effects of Matrix Rhythm Therapy in Axial Spondyloarthritis Patients

NCT06535776 | Completed

• 1 other identifier: matrix35
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic musculoskeletal disease affecting the axial skeleton. The most prominent symptom in patients with axial spondyloarthritis is morning stiffness and chronic low back pain. This is a chronic inflammatory disease group in which exercise and physiotherapy programs are recommended along with medical treatment. Considering the mechanism of action of matrix rhythm therapy, it was predicted that axial spondyloarthritis patients may show improvement.

Conditions

Functional Status; Physical Performance

Outcome Measures

Primary Outcomes (13)

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  The BASDAI is a self-administered questionnaire consisting of six questions about the five main symptoms of fatigue, pain/swelling in the spine and joints, localized areas of tenderness and morning stiffness, measuring both severity and duration. Patients are asked to mark the extent to which they have experienced the relevant symptoms during the previous week. The first 5 questions are assessed using a visual analog scale with no markers on either end except for "not at all" and "very severe". For the amount of morning stiffness, the scale is graded in 15 minute intervals between 0-2 hours. The total score is calculated by averaging the total scale scores. A total score above 4 is considered active disease

  At baseline and after 6 weeks

• Bath Ankylosing Spondylitis Functional Index (BASFI)

  BASFI consists of 8 questions about functional activities in the last week and two questions assessing patients' ability to cope with daily life. Each question is answered on a 10 cm horizontal visual analog scale (VAS). There are no markings on the scale other than the words "easy" and "impossible" at both ends of the line to determine the direction of severity. The total score is calculated by averaging the ten questions, with higher scores indicating severe impairment.

  At baseline and after 6 weeks

• Bath Ankylosing Spondylitis Metrology Index (BASMI)

  BASMI consists of 5 measurements: cervical rotation, tragus-wall distance, lateral flexion, modified schober distance and intermalleolar distance. Each measurement is scored between 0 (mild disease involvement) and 2 (severe disease involvement). Total BASMI score is between 0-10.

  At baseline and after 6 weeks

• Ankylosing Spondylitis Quality of Life Questionnaire (ASYK)

  The questionnaire consists of eighteen questions and each question is scored as yes-1 point and no-2 points. The total score ranges from 0-18, with a higher score indicating a worse quality of life.

  At baseline and after 6 weeks

• Chest circumference measurement

  Chest circumference measurement will be performed to evaluate chest expansion. In particular, in order to prevent contraction of the latissimus dorsi muscle and the associated misleading increase, the difference between maximum inspiration and expiration will be measured at the level of the 4th intercostal space with the patient's arms flexed in the frontal plane and the hands placed behind the head. A difference of less than 5 cm is considered significant for uptake

  At baseline and after 6 weeks

• Pulmonary Function Test (PFT)

  Pulmonary Function Test (PFT) is performed with a spirometer to evaluate lung volume and capacity. Lung functions of the patients will be evaluated with a spirometer (Cosmed Pony FX). As a result of the test, forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), FEV1/FVC values will be recorded.

  At baseline and after 6 weeks

• Modified stoke ankylosing spondylitis spinal score (mSASSS)

  Cervical and lumbar lateral radiographs, which are routinely ordered during the follow-up of the patients, will be evaluated according to the mSASSS system by the Rheumatology specialist of İzmir Buca Seyfi Demirsoy Training and Research Hospital. According to mSASSS, normal vertebrae are scored as 0, erosion/sclerosis/carring as 1, presence of syndesmophytes as 2, and ankylosis as 3 points. For cervical mSASSS, the upper and lower corners of all vertebrae between the lower corner of the C2 vertebra and the upper corner of the T1 vertebra will be evaluated. For lumbar mSASSS, the upper and lower corners of all vertebrae between the lower corner of the T12 vertebra and the upper corner of the sacrum will be evaluated. At the end of the assessment, the cervical mSASSS score, lumbar mSASSS score and total mSASSS score will be recorded.

  At baseline and after 6 weeks

• Ankylosing Spondylitis Disease Activity Score (ASDAS)

  ASDAS was developed in 2009 to assess disease activation. The ASDAS assessment consists of the second, third and sixth questions of the BASDAI, the patient's general self-assessment and the acute phase reactants CRP or ESR variables. The second, third and sixth questions of the BASDI are How would you describe the level of your neck, back, lower back and hip pain, How would you describe the level of your neck, back, lower back and hip pain and How long does your morning stiffness last after waking up? 0.12 x Back pain + 0.06 x Duration of morning stiffness + 0.11 x General assessment of the patient + 0.07 x Peripheral joint swelling/pain + 0.58 x Ln (CRP+1) to obtain the ASDASESH/CRP score and a score above 1.3 is considered active disease.

  At baseline and after 6 weeks

• Sit-Bench Test

  Hip and trunk flexibility will be assessed with the Sit-Bench Test. In this test, patients are placed in a long sitting position with their legs straight. The wall of the sit-stand board is placed on the soles of the feet and then the patient is asked to reach forward without bending the legs. After three reaches, the patient waits for two seconds and the distance between the fingertip of the hand and the board resting on the sole of the foot is recorded in +/- centimeters (cm).

  At baseline and after 6 weeks

• Respiratory Muscle Strength

  Respiratory muscle strength will be measured using MD Diagnostics Brand RP Check Respiratory Muscle Strength (Mip, Mep, Snip) Meter. Maximum inspiratory intraoral pressure and maximum expiratory intraoral pressure will be recorded.

  At baseline and after 6 weeks

• 6 Minute Walk Test (6MWT)

  The 6DYT will be administered indoors in corridor lengths with smooth surfaces, at least 20 meters in length. In the test, with comfortable clothing and shoes suitable for walking, individuals will walk as quickly as possible at their own pace, stopping and using oxygen when necessary. Before and after the test, the heart rate, blood pressure and oxygen saturation (SpO2) of the individual will be measured; the degree of dyspnea according to the Borg scale and quadriceps fatigue will be questioned. At the end of the test, the reason and duration of rest, if any, will be recorded and the individual's six-minute walking distance will be determined in meters.

  At baseline and after 6 weeks

• Chair Sit Up Test

  A simple and quick test commonly used in the clinic to measure functional mobility.For the chair sit up test, the patient will sit in the center of a standard chair with their feet touching the floor. The patient will be asked to sit and stand in this position for 30 seconds without support and the total number of full sit-ups during this time will be recorded. Higher number of repetitions indicates better performance.

  At baseline and after 6 weeks

• Timed Get Up and Go (SDG) Test

  The SDM is a simple and rapid test widely used in the clinic that measures functional mobility of the lower limb, fall risk and performance. According to test scores \<10sec = mobile, 10-20 s = usually independent \> 30 sec = classified as restricted mobile For the SKY test, subjects will sit upright on a standard stool with their feet on the floor. With the command 'start', the patient will be asked to get up without holding on, walk towards an object 3 meters away, turn around, return to the chair and sit down. The time will start when the command is given and end when the person sits back in the chair. The elapsed time will be recorded with a stopwatch (sec).

  At baseline and after 6 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

Home-based exercise program will be explained to patients diagnosed with axSpA by a physiotherapist. All exercises will be repeated with the physiotherapist and explained until understood. Patients will be asked to perform these exercises on their own 3 non-consecutive days a week for 6 weeks. Patients will be called by the physiotherapist on each exercise day and their home exercises will be monitored and recorded in the exercise tracking chart created for each patient. In addition, the patients will be given an exercise follow-up chart and they will be asked to fill in the existing chart and submit it at the end of the 6-week training.

Other: Home-based Exercise

Study group

EXPERIMENTAL

Individuals in this group will be taught home exercises face-to-face in a single session as in the home-based exercise group and will be asked to perform the exercises themselves at home for 3 non-consecutive days a week for 6 weeks. In this group, home exercises will be monitored by phone and recorded with an exercise tracking chart. In addition to home-based exercises, a total of 12 sessions of face-to-face matrix rhythm therapy will be performed, 2 non-consecutive days a week for 6 weeks. Matrix rhythm therapy applications will be applied by a specialist physiotherapist who has received training with the matrix rhythm therapy vibromassage device.

Other: Matrix Rhythm Therapy; Other: Home-based Exercise

Interventions

Home-based Exercise OTHER

Home-based exercise program will be explained to patients diagnosed with axSpA by a physiotherapist. All exercises will be repeated with the physiotherapist and explained until understood. Patients will be asked to perform these exercises on their own 3 non-consecutive days a week for 6 weeks. Patients will be called by the physiotherapist on each exercise day and their home exercises will be monitored and recorded in the exercise tracking chart created for each patient. In addition, the patients will be given an exercise follow-up chart and they will be asked to fill in the existing chart and submit it at the end of the 6-week training.

Also known as: HBE

Control group; Study group

Matrix Rhythm Therapy OTHER

Individuals in this group will be taught home exercises face-to-face in a single session as in the home-based exercise group and will be asked to perform the exercises themselves at home for 3 non-consecutive days a week for 6 weeks. In addition to home-based exercises, a total of 12 sessions of face-to-face matrix rhythm therapy will be performed, 2 non-consecutive days a week for 6 weeks. Matrix rhythm therapy applications will be applied by a specialist physiotherapist who has received training with the matrix rhythm therapy vibromassage device.

Also known as: MRT

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 years and over
• Individuals who can understand and respond to assessments
• Individuals followed with a diagnosis of axial spondyloarthritis for at least 6 months
• Individuals with a BASDAI score above 4

You may not qualify if:

• Individuals with unstable angina pectoris, uncompensated heart failure, myocardial infarction in the last month, which may pose a risk during exercise practices
• Individuals with uncontrolled diabetes, hypertension above 180/110 mmHg and/or severe neuropathy
• Individuals with diagnosed psychiatric illness
• Individuals with diagnosed severe cognitive impairment
• Individuals with severe dyspnea, cyanosis, hemoptysis at rest and/or minimal exertion
• Individuals with previous spinal injury and/or surgery
• Individuals with Psoriasis, Irritable Bowel Disease
• Individuals with pregnancy status/suspicion
• Patients with total ankylosis on direct radiograph or bamboo cane appearance on thoracolumbar radiograph

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Izmir Democracy Univercity

Izmir, 35000, Turkey (Türkiye)

Location

Related Publications (1)

• Navarro-Compan V, Sepriano A, El-Zorkany B, van der Heijde D. Axial spondyloarthritis. Ann Rheum Dis. 2021 Dec;80(12):1511-1521. doi: 10.1136/annrheumdis-2021-221035. Epub 2021 Oct 6.

  PMID: 34615639 BACKGROUND

Related Links

• Related Info

Study Officials

• Betül Taspinar, Prof.Dr.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Onur Engin, Assist.Prof.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Önay Gerçik, Assist.Prof.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: October 20, 2024
• Primary Completion: September 6, 2025
• Study Completion: December 5, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)