Effects of Matrix Rhythm Therapy in Axial Spondyloarthritis Patients

NCT ID: NCT06535776

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-20
• Study Completion Date: 2025-12-05

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.

Conditions

Functional Status; Physical Performance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

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.

Group Type: ACTIVE_COMPARATOR

Home-based Exercise

Intervention Type: 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.

Study group

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.

Group Type: EXPERIMENTAL

Matrix Rhythm Therapy

Intervention Type: 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.

Home-based Exercise

Intervention Type: 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.

Interventions

Matrix Rhythm Therapy

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.

Intervention Type: OTHER

Home-based Exercise

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.

Intervention Type: OTHER

Other Intervention Names

MRT; HBE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Democracy University

OTHER

Sponsor Role: lead

Responsible Party

Ferruh Taşpınar

Study Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Betül Taspinar, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

Onur Engin, Assist.Prof.

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

Önay Gerçik, Assist.Prof.

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

Locations

Izmir Democracy Univercity

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 34615639 (View on PubMed)

Related Links

http://pubmed.ncbi.nlm.nih.gov/34615639/

Related Info

Other Identifiers

matrix35

Identifier Type: -

Identifier Source: org_study_id