Functional StatusNCT06535776
Effects of Matrix Rhythm Therapy in Axial Spondyloarthritis Patients
A study testing Matrix Rhythm Therapy and Home-based Exercise in people with Functional Status and Physical Performance, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Status, Physical Performance
- What is being tested?
- Matrix Rhythm Therapy and Home-based Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2024to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Matrix Rhythm Therapy on Functional Status, Quality of Life, Respiratory Functions and Physical Performance in Axial Spondyloarthritis Patients
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.
Read the detailed description
Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic musculoskeletal disease affecting the axial skeleton. In addition to axial and musculoskeletal manifestations (arthritis, enthesitis, dactylitis), extramusculoskeletal manifestations (acute anterior uveitis, inflammatory bowel disease, psoriasis) are often present. In axSpA, the primary pathophysiology occurs in the entheses, the site of attachment of muscles to bones, and in the subchondral bone. In addition, secondary synovitis accompanies the pathology occurring in the enthesis. Mechanical stresses are very important in the onset and progression of axSpA. Axial inflammation causes bone destruction and plays an important role in the pathophysiology of axSpA.
The most common and frequently occurring symptom of axSpA is chronic (> 3 months) and almost daily chronic low back pain (CLBP) with morning stiffness. Pain and stiffness usually involve the lumbar region and buttocks, but any level of the spine can be affected. In addition, axial inflammation (synovitis and enthesitis) in axSpA causes irreversible structural damage and reduces spinal mobility. Spinal limitation is a late sign of axSpA.
Arthritis and enthesitis are the most common peripheral symptoms in axSpA and occur in approximately 30% of patients. Peripheral arthritis, which presents with edema and pain in the joints, is usually asymmetric monoarthritis/oligoarthritis and usually involves the lower extremities. Peripheral enthesitis usually presents with pain, stiffness and/or tenderness. Frequently, achilles enthesitis is seen in the lower extremities, but as axial enthesitis, it causes chest/back pain with synovitis of the axial joints. The combination of pharmacologic and non-pharmacologic methods in the treatment of axSpA has been shown to provide optimum benefit to patients. Pharmacologically, NSAIDs, tumor necrosis factor inhibitors, interleukin-17 inhibitors and Janus kinase inhibitors are preferred. In non-pharmacologic treatments, physiotherapy and exercise applications are recommended by the International Spondyloarthritis Society (ASAS-EULAR) with evidence grades 1a and 2b, respectively.
Exercise is the gold standard in the management of axSpA due to its proven benefits on disease outcomes independent of pharmacologic treatment. In the literature, studies conducted to evaluate the effects of exercise types (in-water exercises, group exercises, supervised individual exercises, aerobic exercises, pilates, tai-chi exercises, therapeutic exercises, proprioceptive exercises) on axSpA patients are frequently encountered. Due to the chronic nature of axSpA, continuity of treatment and time management, these exercises are modified and usually applied as home-based exercises. Home-based exercises are easily applicable and cost-effective, allowing patients to exercise while continuing their normal lives. In the literature, home-based exercise approaches have been shown to have positive effects on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), scores, quality of life, pain and functional capacity in axSpA patients.
Exercise helps to regulate circulation, excrete metabolites and increase mitochondrial activity as a result of relaxation and contraction of muscles during activity. Some studies have shown pathological changes in the extracellular matrix of affected tissues in patients with axSpA. Successful treatment should focus on mobility of the extracellular matrix. Matrix metalloproteinase-mediated degradation of type II collagen, the main exacellular protein in cartilage, has been reported to be increased in patients with
ankylosing spondylitis (AS) and decreased with treatment. This is an important finding in diagnosis and prognosis. In order to correct this pathology in the matrix, supportive therapies that treat at the cellular level should be added together with exercise. It has been predicted that the effect of exercises will increase more with the reorganization of the extracellular matrix, restoration of its rhythm and regulation of circulation.
The Matrix Rhythm Therapy (MaRhyThe) vibromassage method for restoring the mobility and rhythm of the extracellular matrix was developed by Dr. Ulrich Randoll in Germany. This vibromassage device aims to reactivate cell metabolism by rhythmically stretching the deep tissue with its head. After micro stretching with the help of vibromassage, the tissues gain their unique natural vibration and the matrix rhythm improves. It has been reported that healthy muscles have vibrations between 8-12 Hz. and this is the same frequency as the alpha rhythm in the brain. However, if there is a pathology in the muscles, the vibration of the tissues is disturbed and the tissues move away from the alpha rhythm. It has even been reported that the rhythm of the tissues changes even during the day and metabolism is affected by this. In their study, Van Moorsel D examined the rhythms in skeletal muscles during the day and night by taking biopsy tissue from patients. They stated that the strong rhythms that change in biological clocks of individuals direct their oxidative metabolism. Disruption of these rhythms is associated with altered elasticity, plasticity and altered circulation at the cellular level.
There are studies in the literature using MaRhyThe in different populations. However, no studies have been found in patients with chronic and progressive axSpA affecting the extracellular matrix and peripheral tissues. AxSpA patients with axial skeletal involvement, which is frequently seen in the community, is a disease in which Matrix Rhythm Therapy can be applied. AxSpA is a chronic inflammatory disease group in which the use of exercise and supportive physiotherapy methods along with medical treatments is recommended in treatment guidelines. Therefore, in our study, it was decided to perform matrix rhythm therapy for the first time in AxSpA patients. Considering the mechanism of action of MaRhyThe, it is predicted to improve the effectiveness of exercise in patients with AxSpA by increasing the extracellular matrix fluid, excretion of metabolites and circulation. Therefore, our study was planned to examine the effect of Matrix Rhythm Therapy on functional status, quality of life, respiratory function and physical performance in patients with axSpA.
- Conditions
- Functional Status, Physical Performance
- Being tested
- Matrix Rhythm Therapy, Home-based Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matrix Rhythm TherapyOther
Also called MRT
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.
Home-based ExerciseOther
Also called HBE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Matrix Rhythm Therapy; Other: Home-based Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: At baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start20 Oct 2024
- Primary completion6 Sep 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferruh Taşpınar, Izmir Democracy University
- Investigators
- Betül Taspinar, Prof.Dr., Principal investigator, Izmir Democracy UniversityOnur Engin, Assist.Prof., Principal investigator, Izmir Democracy UniversityÖnay Gerçik, Assist.Prof., Principal investigator, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535776
- Sponsor's protocol ID
- matrix35
- Status last verified
- Dec 2025
- First submitted
- 30 Jul 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34615639
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Matrix Rhythm Therapy on Functional Status, Quality of Life, Respiratory Functions and Physical Performance in Axial Spondyloarthritis Patients
- ClinicalTrials.gov ID
- NCT06535776
- Acronym / sponsor ID
- matrix35
- Conditions
- Functional Status, Physical Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 6 Sep 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic musculoskeletal disease affecting the axial skeleton. In addition to axial and musculoskeletal manifestations (arthritis, enthesitis, dactylitis), extramusculoskeletal manifestations (acute anterior uveitis, inflammatory bowel disease, psoriasis) are often present. In axSpA, the primary pathophysiology occurs in the entheses, the site of attachment of muscles to bones, and in the subchondral bone. In addition, secondary synovitis accompanies the pathology occurring in the enthesis. Mechanical stresses are very important in the onset and progression of axSpA. Axial inflammation causes bone destruction and plays an important role in the pathophysiology of axSpA.
The most common and frequently occurring symptom of axSpA is chronic (> 3 months) and almost daily chronic low back pain (CLBP) with morning stiffness. Pain and stiffness usually involve the lumbar region and buttocks, but any level of the spine can be affected. In addition, axial inflammation (synovitis and enthesitis) in axSpA causes irreversible structural damage and reduces spinal mobility. Spinal limitation is a late sign of axSpA.
Arthritis and enthesitis are the most common peripheral symptoms in axSpA and occur in approximately 30% of patients. Peripheral arthritis, which presents with edema and pain in the joints, is usually asymmetric monoarthritis/oligoarthritis and usually involves the lower extremities. Peripheral enthesitis usually presents with pain, stiffness and/or tenderness. Frequently, achilles enthesitis is seen in the lower extremities, but as axial enthesitis, it causes chest/back pain with synovitis of the axial joints. The combination of pharmacologic and non-pharmacologic methods in the treatment of axSpA has been shown to provide optimum benefit to patients. Pharmacologically, NSAIDs, tumor necrosis factor inhibitors, interleukin-17 inhibitors and Janus kinase inhibitors are preferred. In non-pharmacologic treatments, physiotherapy and exercise applications are recommended by the International Spondyloarthritis Society (ASAS-EULAR) with evidence grades 1a and 2b, respectively.
Exercise is the gold standard in the management of axSpA due to its proven benefits on disease outcomes independent of pharmacologic treatment. In the literature, studies conducted to evaluate the effects of exercise types (in-water exercises, group exercises, supervised individual exercises, aerobic exercises, pilates, tai-chi exercises, therapeutic exercises, proprioceptive exercises) on axSpA patients are frequently encountered. Due to the chronic nature of axSpA, continuity of treatment and time management, these exercises are modified and usually applied as home-based exercises. Home-based exercises are easily applicable and cost-effective, allowing patients to exercise while continuing their normal lives. In the literature, home-based exercise approaches have been shown to have positive effects on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), scores, quality of life, pain and functional capacity in axSpA patients.
Exercise helps to regulate circulation, excrete metabolites and increase mitochondrial activity as a result of relaxation and contraction of muscles during activity. Some studies have shown pathological changes in the extracellular matrix of affected tissues in patients with axSpA. Successful treatment should focus on mobility of the extracellular matrix. Matrix metalloproteinase-mediated degradation of type II collagen, the main exacellular protein in cartilage, has been reported to be increased in patients with
ankylosing spondylitis (AS) and decreased with treatment. This is an important finding in diagnosis and prognosis. In order to correct this pathology in the matrix, supportive therapies that treat at the cellular level should be added together with exercise. It has been predicted that the effect of exercises will increase more with the reorganization of the extracellular matrix, restoration of its rhythm and regulation of circulation.
The Matrix Rhythm Therapy (MaRhyThe) vibromassage method for restoring the mobility and rhythm of the extracellular matrix was developed by Dr. Ulrich Randoll in Germany. This vibromassage device aims to reactivate cell metabolism by rhythmically stretching the deep tissue with its head. After micro stretching with the help of vibromassage, the tissues gain their unique natural vibration and the matrix rhythm improves. It has been reported that healthy muscles have vibrations between 8-12 Hz. and this is the same frequency as the alpha rhythm in the brain. However, if there is a pathology in the muscles, the vibration of the tissues is disturbed and the tissues move away from the alpha rhythm. It has even been reported that the rhythm of the tissues changes even during the day and metabolism is affected by this. In their study, Van Moorsel D examined the rhythms in skeletal muscles during the day and night by taking biopsy tissue from patients. They stated that the strong rhythms that change in biological clocks of individuals direct their oxidative metabolism. Disruption of these rhythms is associated with altered elasticity, plasticity and altered circulation at the cellular level.
There are studies in the literature using MaRhyThe in different populations. However, no studies have been found in patients with chronic and progressive axSpA affecting the extracellular matrix and peripheral tissues. AxSpA patients with axial skeletal involvement, which is frequently seen in the community, is a disease in which Matrix Rhythm Therapy can be applied. AxSpA is a chronic inflammatory disease group in which the use of exercise and supportive physiotherapy methods along with medical treatments is recommended in treatment guidelines. Therefore, in our study, it was decided to perform matrix rhythm therapy for the first time in AxSpA patients. Considering the mechanism of action of MaRhyThe, it is predicted to improve the effectiveness of exercise in patients with AxSpA by increasing the extracellular matrix fluid, excretion of metabolites and circulation. Therefore, our study was planned to examine the effect of Matrix Rhythm Therapy on functional status, quality of life, respiratory function and physical performance in patients with axSpA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Home-based ExerciseHome-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. |
| Study group | Experimental | Other: Matrix Rhythm Therapy, Other: Home-based ExerciseIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Matrix Rhythm TherapyAlso: MRTIndividuals 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. | Other | Study group |
| Home-based ExerciseAlso: HBEHome-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 | Control group, Study group |
Primary outcome
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: At baseline and after 6 weeks
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
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: At baseline and after 6 weeks
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.
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: At baseline and after 6 weeks
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.
Ankylosing Spondylitis Quality of Life Questionnaire (ASYK)
Time frame: At baseline and after 6 weeks
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.
Chest circumference measurement
Time frame: At baseline and after 6 weeks
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
Pulmonary Function Test (PFT)
Time frame: At baseline and after 6 weeks
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.
Modified stoke ankylosing spondylitis spinal score (mSASSS)
Time frame: At baseline and after 6 weeks
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.
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: At baseline and after 6 weeks
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.
Sit-Bench Test
Time frame: At baseline and after 6 weeks
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).
Respiratory Muscle Strength
Time frame: At baseline and after 6 weeks
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.
6 Minute Walk Test (6MWT)
Time frame: At baseline and after 6 weeks
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.
Chair Sit Up Test
Time frame: At baseline and after 6 weeks
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.
Timed Get Up and Go (SDG) Test
Time frame: At baseline and after 6 weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 34615639Navarro-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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betül Taspinar, Prof.Dr. principal investigator
Izmir Democracy University
Onur Engin, Assist.Prof. principal investigator
Izmir Democracy University
Önay Gerçik, Assist.Prof. principal investigator
Izmir Democracy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Matrix Rhythm Therapy and Home-based Exercise in people with Functional Status and Physical Performance, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (time frame: At baseline and after 6 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06535776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.