<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04424589</url>
  </required_header>
  <id_info>
    <org_study_id>EPI-01-2020</org_study_id>
    <nct_id>NCT04424589</nct_id>
  </id_info>
  <brief_title>Efficacy of Myofascial Release in Patients With Axial Spondyloarthritis.</brief_title>
  <official_title>Efficacy of Myofascial Release Compared With Sham Therapy on Joint Range of Motion in Patients With Axial Spondyloarthritis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de la Sabana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de la Sabana</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Axial spondyloarthritis (AS), is a chronic and disabling disease that mainly affects young&#xD;
      people, generating clear limitations in mobility and functional capacity in patients who&#xD;
      develop this disease. Although pharmacological treatment is the basis of the therapeutic&#xD;
      treatment of (AS), non-pharmacological treatment is a fundamental complement that guarantees&#xD;
      the optimization of movement patterns, in turn favoring independence in the basic activities&#xD;
      of life daily through the management and control of the derived signs and symptoms. Several&#xD;
      studies have demonstrated the effectiveness of physiotherapy in treating symptoms in patients&#xD;
      with AS, one of these studies is the Cochrane review developed by Dagfinrud et al. One of the&#xD;
      techniques described by the Cochrane Review in the management of symptoms is orthopedic&#xD;
      manual therapy (OMT), defined as a specialized area of physical therapy used for the&#xD;
      treatment of neuro-musculoskeletal conditions, based on clinical reasoning, using approaches&#xD;
      highly specific treatment plans that include manual techniques and therapeutic exercises.&#xD;
&#xD;
      Among these manual techniques, it includes myofascial induction as the primary technique of&#xD;
      choice for the management of soft tissue and fascial system restrictions, it has been shown&#xD;
      to be in rheumatic diseases such as fibromyalgia and osteoarthritis, as well as in&#xD;
      non-inflammatory mechanical diseases such as non-specific low back pain, a low-cost, rapid&#xD;
      therapeutic action strategy with sustained gains over time in managing global symptoms.&#xD;
      Currently, the effects of myofascial induction on the mobility and function of patients with&#xD;
      AS are unknown, despite the excellent results that these techniques have shown in&#xD;
      dysfunctions of non-autoimmune musculoskeletal origin. For this reason, this study will seek&#xD;
      to evaluate the efficacy of myofascial release compared to sham therapy in joint range of&#xD;
      motion in patients diagnosed with axial spondyloarthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trial design: Controlled parallel double blind superiority clinical trial. Participants of&#xD;
      the trial: Patients with a diagnosis of axial spondyloarthritis, of legal age, attending the&#xD;
      rheumatology service of an outpatient clinic in the city of Bogotá. Planned trial period: The&#xD;
      intervention per participant is designed to develop 6 therapy sessions 2 times per week over&#xD;
      the course of 3 weeks. It is not planned to follow up the participants in time after the end&#xD;
      of the study and treatment time. The total duration of the project will be 4 months while the&#xD;
      necessary population is recruited to complete the sample size.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bath Ankylosing Spondylitis Metrology Index (BASMI)</measure>
    <time_frame>3 weeks</time_frame>
    <description>Index that examines 4 axial measurements (cervical rotation, Schober test, lateral trunk flexion, tragus wall distance), also includes a measurement of peripheral mobility (intermaleolar distance), The measurement of these variables is carried out comparatively, in at least two attempts, obtaining the averages of the measurements to calculate the final score based on the 11-point table.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bath Ankylosing Spondylitis Functional Index (BASFI)</measure>
    <time_frame>3 Weeks</time_frame>
    <description>BASFI is a set of 10 questions designed to determine the degree of functional limitation in people with AS. The score is generated by giving a value of 1 to 10 to each of the questions, once this process has been carried out, this value is divided by 10 and the higher the score given by the scale, the greater the estimates functional limitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>El Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)</measure>
    <time_frame>3 weeks</time_frame>
    <description>This index is developed to measure disease activity in patients with ankylosing spondylitis. It consists of 6 questions that include the components of fatigue, spinal pain, joint pain / inflammation, pain in the entheses and morning stiffness. The score is generated by giving a value from 1 to 10 to each of the questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ASQoL (Ankylosing Spondylitis Quality of Life)</measure>
    <time_frame>3 Weeks</time_frame>
    <description>It consists of 18 questions, with the possibility of a dichotomous answer (Yes-No) The global score ranges from 0 to 18</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">82</enrollment>
  <condition>Ankylosing Spondylitis</condition>
  <arm_group>
    <arm_group_label>Myofascial release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Myofascial release or induction (MFR) is a widely used manual therapy treatment involving specifically guided, low-load, long-lasting mechanical forces to manipulate the myofascial complex, aimed at restoring optimal length, decreasing pain, and improving function. Manual therapists often use their hands using their knuckles, elbows, or other instrumental tools to slowly penetrate the layers of the fascia, using applied pressure with a few kilograms of force that can strain the restricted fascia, this implies a guided gentle stretch.&#xD;
The experimental group will receive 1 examination session and 6 myofascial release sessions carried out by a physiotherapist specialized in orthopedic manual therapy, superficial and deep techniques will be applied in the cervical region, for the spinal at the level of the quadratus lumborum, sacroiliac region and upper trapezius. 2 sessions per week over the course of 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Therapy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The control group will receive 1 examination session and 6 simulated myofascial releasesessions, where a physiotherapist will apparently apply the same techniques and maneuvers of myofascial release, however, they will not follow the basic principles of technique execution, which does a procedure with a placebo effect.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Myofascial release</intervention_name>
    <description>Myofascial release or induction (IMF) is a widely used manual therapy treatment involving specifically guided, low-load, long-lasting mechanical forces to manipulate the myofascial complex, aimed at restoring optimal length, decreasing pain, and improving function. The experimental group will receive 1 examination session and 6 myofascial induction sessions carried out by a physiotherapist specialized in orthopedic manual therapy, superficial and deep techniques will be applied in the cervical region, for spinal at the level of the lumbar square, sacroiliac region and upper trapezius. 2 sessions per week over the course of 3 weeks.</description>
    <arm_group_label>Myofascial release</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham therapy</intervention_name>
    <description>The control group will receive 1 examination session and 6 simulated myofascial induction sessions, where a physiotherapist will apparently apply the same techniques and maneuvers of myofascial induction, however, they will not follow the basic principles of technique execution, which does a procedure with a placebo effect.</description>
    <arm_group_label>Sham Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of ankylosing spondyloarthritis confirmed by rheumatologist&#xD;
             regardless of the level of disease activity.&#xD;
&#xD;
          -  Patients with cognitive ability to follow orders.&#xD;
&#xD;
          -  Patients who agree to participate in the study and firm informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving oral or parenteral coagulation therapy.&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patients with Kinesiophobia.&#xD;
&#xD;
          -  Patients with previous physical therapy in the last 15 days.&#xD;
&#xD;
          -  Presence of active cancer, current treatment in chemo or radiotherapy.&#xD;
&#xD;
          -  Patients who do not wish to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>María Alejandra Sánchez Vera, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de la Sabana</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>María Alejandra Sánchez Vera</last_name>
    <phone>+573115162235</phone>
    <email>Mariasanver@unisabana.edu.co</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Diego Alejandro Jaimes Fernández</last_name>
    <email>diegojf@unisabana.edu.co</email>
  </overall_contact_backup>
  <reference>
    <citation>Perrotta FM, Musto A, Lubrano E. New Insights in Physical Therapy and Rehabilitation in Axial Spondyloarthritis: A Review. Rheumatol Ther. 2019 Dec;6(4):479-486. doi: 10.1007/s40744-019-00170-x. Epub 2019 Aug 13.</citation>
    <PMID>31410786</PMID>
  </reference>
  <reference>
    <citation>Dagfinrud H, Kvien TK, Hagen KB. The Cochrane review of physiotherapy interventions for ankylosing spondylitis. J Rheumatol. 2005 Oct;32(10):1899-906.</citation>
    <PMID>16206344</PMID>
  </reference>
  <reference>
    <citation>Cathcart E, McSweeney T, Johnston R, Young H, Edwards DJ. Immediate biomechanical, systemic, and interoceptive effects of myofascial release on the thoracic spine: A randomised controlled trial. J Bodyw Mov Ther. 2019 Jan;23(1):74-81. doi: 10.1016/j.jbmt.2018.10.006. Epub 2018 Oct 24.</citation>
    <PMID>30691766</PMID>
  </reference>
  <reference>
    <citation>Arguisuelas MD, Lison JF, Domenech-Fernandez J, Martinez-Hurtado I, Salvador Coloma P, Sanchez-Zuriaga D. Effects of myofascial release in erector spinae myoelectric activity and lumbar spine kinematics in non-specific chronic low back pain: Randomized controlled trial. Clin Biomech (Bristol, Avon). 2019 Mar;63:27-33. doi: 10.1016/j.clinbiomech.2019.02.009. Epub 2019 Feb 14.</citation>
    <PMID>30784788</PMID>
  </reference>
  <results_reference>
    <citation>Florez Garcia MT, Carmona L, Almodovar R, Fernandez de Las Penas C, Garcia Perez F, Perez Manzanero MA, Garcia Garcia JM, Soriano Segarra L, Jimenez Diaz JF, Mendoza Laiz N, de Miguel Mendieta E, Torre Alonso JC, Linares Ferrando LF, Collantes Estevez E, Sanz Sanz J, Zarco Montejo P. Recommendations for the prescription of physical exercise for patients with spondyloarthritis. Reumatol Clin (Engl Ed). 2019 Mar-Apr;15(2):77-83. doi: 10.1016/j.reuma.2017.06.014. Epub 2017 Aug 12. English, Spanish.</citation>
    <PMID>28807651</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
    <mesh_term>Axial Spondyloarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04424589
org study id: EPI-01-2020
nct id: NCT04424589
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Axial spondyloarthritis (AS), is a chronic and disabling disease that mainly affects young
      people, generating clear limitations in mobility and functional capacity in patients who
      develop this disease. Although pharmacological treatment is the basis of the therapeutic
      treatment of (AS), non-pharmacological treatment is a fundamental complement that guarantees
      the optimization of movement patterns, in turn favoring independence in the basic activities
      of life daily through the management and control of the derived signs and symptoms. Several
      studies have demonstrated the effectiveness of physiotherapy in treating symptoms in patients
      with AS, one of these studies is the Cochrane review developed by Dagfinrud et al. One of the
      techniques described by the Cochrane Review in the management of symptoms is orthopedic
      manual therapy (OMT), defined as a specialized area of physical therapy used for the
      treatment of neuro-musculoskeletal conditions, based on clinical reasoning, using approaches
      highly specific treatment plans that include manual techniques and therapeutic exercises.

      Among these manual techniques, it includes myofascial induction as the primary technique of
      choice for the management of soft tissue and fascial system restrictions, it has been shown
      to be in rheumatic diseases such as fibromyalgia and osteoarthritis, as well as in
      non-inflammatory mechanical diseases such as non-specific low back pain, a low-cost, rapid
      therapeutic action strategy with sustained gains over time in managing global symptoms.
      Currently, the effects of myofascial induction on the mobility and function of patients with
      AS are unknown, despite the excellent results that these techniques have shown in
      dysfunctions of non-autoimmune musculoskeletal origin. For this reason, this study will seek
      to evaluate the efficacy of myofascial release compared to sham therapy in joint range of
      motion in patients diagnosed with axial spondyloarthritis.
Trial design: Controlled parallel double blind superiority clinical trial. Participants of
      the trial: Patients with a diagnosis of axial spondyloarthritis, of legal age, attending the
      rheumatology service of an outpatient clinic in the city of Bogotá. Planned trial period: The
      intervention per participant is designed to develop 6 therapy sessions 2 times per week over
      the course of 3 weeks. It is not planned to follow up the participants in time after the end
      of the study and treatment time. The total duration of the project will be 4 months while the
      necessary population is recruited to complete the sample size.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI)
time frame: 3 weeks
description: Index that examines 4 axial measurements (cervical rotation, Schober test, lateral trunk flexion, tragus wall distance), also includes a measurement of peripheral mobility (intermaleolar distance), The measurement of these variables is carried out comparatively, in at least two attempts, obtaining the averages of the measurements to calculate the final score based on the 11-point table.
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
time frame: 3 Weeks
description: BASFI is a set of 10 questions designed to determine the degree of functional limitation in people with AS. The score is generated by giving a value of 1 to 10 to each of the questions, once this process has been carried out, this value is divided by 10 and the higher the score given by the scale, the greater the estimates functional limitation.
measure: El Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
time frame: 3 weeks
description: This index is developed to measure disease activity in patients with ankylosing spondylitis. It consists of 6 questions that include the components of fatigue, spinal pain, joint pain / inflammation, pain in the entheses and morning stiffness. The score is generated by giving a value from 1 to 10 to each of the questions.
measure: ASQoL (Ankylosing Spondylitis Quality of Life)
time frame: 3 Weeks
description: It consists of 18 questions, with the possibility of a dichotomous answer (Yes-No) The global score ranges from 0 to 18
arm group label: Myofascial release
arm group type: Experimental
description: Myofascial release or induction (MFR) is a widely used manual therapy treatment involving specifically guided, low-load, long-lasting mechanical forces to manipulate the myofascial complex, aimed at restoring optimal length, decreasing pain, and improving function. Manual therapists often use their hands using their knuckles, elbows, or other instrumental tools to slowly penetrate the layers of the fascia, using applied pressure with a few kilograms of force that can strain the restricted fascia, this implies a guided gentle stretch.
The experimental group will receive 1 examination session and 6 myofascial release sessions carried out by a physiotherapist specialized in orthopedic manual therapy, superficial and deep techniques will be applied in the cervical region, for the spinal at the level of the quadratus lumborum, sacroiliac region and upper trapezius. 2 sessions per week over the course of 3 weeks.
arm group label: Sham Therapy
arm group type: Sham Comparator
description: The control group will receive 1 examination session and 6 simulated myofascial releasesessions, where a physiotherapist will apparently apply the same techniques and maneuvers of myofascial release, however, they will not follow the basic principles of technique execution, which does a procedure with a placebo effect.
intervention type: Other
intervention name: Myofascial release
description: Myofascial release or induction (IMF) is a widely used manual therapy treatment involving specifically guided, low-load, long-lasting mechanical forces to manipulate the myofascial complex, aimed at restoring optimal length, decreasing pain, and improving function. The experimental group will receive 1 examination session and 6 myofascial induction sessions carried out by a physiotherapist specialized in orthopedic manual therapy, superficial and deep techniques will be applied in the cervical region, for spinal at the level of the lumbar square, sacroiliac region and upper trapezius. 2 sessions per week over the course of 3 weeks.
arm group label: Myofascial release
intervention type: Other
intervention name: Sham therapy
description: The control group will receive 1 examination session and 6 simulated myofascial induction sessions, where a physiotherapist will apparently apply the same techniques and maneuvers of myofascial induction, however, they will not follow the basic principles of technique execution, which does a procedure with a placebo effect.
arm group label: Sham Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: María Alejandra Sánchez Vera, PT
role: Principal Investigator
affiliation: Universidad de la Sabana
last name: María Alejandra Sánchez Vera
phone: +573115162235
email: Mariasanver@unisabana.edu.co
last name: Diego Alejandro Jaimes Fernández
email: diegojf@unisabana.edu.co
citation: Perrotta FM, Musto A, Lubrano E. New Insights in Physical Therapy and Rehabilitation in Axial Spondyloarthritis: A Review. Rheumatol Ther. 2019 Dec;6(4):479-486. doi: 10.1007/s40744-019-00170-x. Epub 2019 Aug 13.
PMID: 31410786
citation: Dagfinrud H, Kvien TK, Hagen KB. The Cochrane review of physiotherapy interventions for ankylosing spondylitis. J Rheumatol. 2005 Oct;32(10):1899-906.
PMID: 16206344
citation: Cathcart E, McSweeney T, Johnston R, Young H, Edwards DJ. Immediate biomechanical, systemic, and interoceptive effects of myofascial release on the thoracic spine: A randomised controlled trial. J Bodyw Mov Ther. 2019 Jan;23(1):74-81. doi: 10.1016/j.jbmt.2018.10.006. Epub 2018 Oct 24.
PMID: 30691766
citation: Arguisuelas MD, Lison JF, Domenech-Fernandez J, Martinez-Hurtado I, Salvador Coloma P, Sanchez-Zuriaga D. Effects of myofascial release in erector spinae myoelectric activity and lumbar spine kinematics in non-specific chronic low back pain: Randomized controlled trial. Clin Biomech (Bristol, Avon). 2019 Mar;63:27-33. doi: 10.1016/j.clinbiomech.2019.02.009. Epub 2019 Feb 14.
PMID: 30784788
citation: Florez Garcia MT, Carmona L, Almodovar R, Fernandez de Las Penas C, Garcia Perez F, Perez Manzanero MA, Garcia Garcia JM, Soriano Segarra L, Jimenez Diaz JF, Mendoza Laiz N, de Miguel Mendieta E, Torre Alonso JC, Linares Ferrando LF, Collantes Estevez E, Sanz Sanz J, Zarco Montejo P. Recommendations for the prescription of physical exercise for patients with spondyloarthritis. Reumatol Clin (Engl Ed). 2019 Mar-Apr;15(2):77-83. doi: 10.1016/j.reuma.2017.06.014. Epub 2017 Aug 12. English, Spanish.
PMID: 28807651
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
mesh term: Axial Spondyloarthritis
sharing ipd: No