Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535776
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Effects of Matrix Rhythm Therapy in Axial Spondyloarthritis Patients
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 monoarthritisoligoarthritis and usually involves the lower extremities Peripheral enthesitis usually presents with pain stiffness andor tenderness Frequently achilles enthesitis is seen in the lower extremities but as axial enthesitis it causes chestback 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
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 monoarthritisoligoarthritis and usually involves the lower extremities Peripheral enthesitis usually presents with pain stiffness andor tenderness Frequently achilles enthesitis is seen in the lower extremities but as axial enthesitis it causes chestback 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None