Clinical trial NCT06535776: Effects of Matrix Rhythm Therapy in Axial Spondyloarthritis Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Status
Physical Performance
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: At baseline and after 6 weeks
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: At baseline and after 6 weeks
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: At baseline and after 6 weeks
measure: Ankylosing Spondylitis Quality of Life Questionnaire (ASYK)
timeFrame: At baseline and after 6 weeks
measure: Chest circumference measurement
timeFrame: At baseline and after 6 weeks
measure: Pulmonary Function Test (PFT)
timeFrame: At baseline and after 6 weeks
measure: Modified stoke ankylosing spondylitis spinal score (mSASSS)
timeFrame: At baseline and after 6 weeks
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: At baseline and after 6 weeks
measure: Sit-Bench Test
timeFrame: At baseline and after 6 weeks
measure: Respiratory Muscle Strength
timeFrame: At baseline and after 6 weeks
measure: 6 Minute Walk Test (6MWT)
timeFrame: At baseline and after 6 weeks
measure: Chair Sit Up Test
timeFrame: At baseline and after 6 weeks
measure: Timed Get Up and Go (SDG) Test
timeFrame: At baseline and after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Democracy Univercity
Study officials:
affiliation: Izmir Democracy University
name: Betül Taspinar, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir Democracy University
name: Onur Engin, Assist.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir Democracy University
name: Önay Gerçik, Assist.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.