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Efficacy of Myofascial Release in Patients With Axial Spondyloarthritis.

Primary Purpose

Ankylosing Spondylitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Myofascial release
Sham therapy
Sponsored by
Universidad de la Sabana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a diagnosis of ankylosing spondyloarthritis confirmed by rheumatologist regardless of the level of disease activity.
  • Patients with cognitive ability to follow orders.
  • Patients who agree to participate in the study and firm informed consent.

Exclusion Criteria:

  • Patients receiving oral or parenteral coagulation therapy.
  • Pregnant women
  • Patients with Kinesiophobia.
  • Patients with previous physical therapy in the last 15 days.
  • Presence of active cancer, current treatment in chemo or radiotherapy.
  • Patients who do not wish to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Myofascial release

    Sham Therapy

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Bath Ankylosing Spondylitis Metrology Index (BASMI)
    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.

    Secondary Outcome Measures

    Bath Ankylosing Spondylitis Functional Index (BASFI)
    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.
    El Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
    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.
    ASQoL (Ankylosing Spondylitis Quality of Life)
    It consists of 18 questions, with the possibility of a dichotomous answer (Yes-No) The global score ranges from 0 to 18

    Full Information

    First Posted
    June 6, 2020
    Last Updated
    June 6, 2020
    Sponsor
    Universidad de la Sabana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04424589
    Brief Title
    Efficacy of Myofascial Release in Patients With Axial Spondyloarthritis.
    Official Title
    Efficacy of Myofascial Release Compared With Sham Therapy on Joint Range of Motion in Patients With Axial Spondyloarthritis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2020 (Anticipated)
    Primary Completion Date
    March 2021 (Anticipated)
    Study Completion Date
    June 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidad de la Sabana

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankylosing Spondylitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    82 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Myofascial release
    Arm Type
    Experimental
    Arm 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 Title
    Sham Therapy
    Arm Type
    Sham Comparator
    Arm 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(s)
    Myofascial release
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    Sham therapy
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Bath Ankylosing Spondylitis Metrology Index (BASMI)
    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.
    Time Frame
    3 weeks
    Secondary Outcome Measure Information:
    Title
    Bath Ankylosing Spondylitis Functional Index (BASFI)
    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.
    Time Frame
    3 Weeks
    Title
    El Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
    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.
    Time Frame
    3 weeks
    Title
    ASQoL (Ankylosing Spondylitis Quality of Life)
    Description
    It consists of 18 questions, with the possibility of a dichotomous answer (Yes-No) The global score ranges from 0 to 18
    Time Frame
    3 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with a diagnosis of ankylosing spondyloarthritis confirmed by rheumatologist regardless of the level of disease activity. Patients with cognitive ability to follow orders. Patients who agree to participate in the study and firm informed consent. Exclusion Criteria: Patients receiving oral or parenteral coagulation therapy. Pregnant women Patients with Kinesiophobia. Patients with previous physical therapy in the last 15 days. Presence of active cancer, current treatment in chemo or radiotherapy. Patients who do not wish to participate in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    María Alejandra Sánchez Vera
    Phone
    +573115162235
    Email
    Mariasanver@unisabana.edu.co
    First Name & Middle Initial & Last Name or Official Title & Degree
    Diego Alejandro Jaimes Fernández
    Email
    diegojf@unisabana.edu.co
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    María Alejandra Sánchez Vera, PT
    Organizational Affiliation
    Universidad de la Sabana
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31410786
    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.
    Results Reference
    background
    PubMed Identifier
    16206344
    Citation
    Dagfinrud H, Kvien TK, Hagen KB. The Cochrane review of physiotherapy interventions for ankylosing spondylitis. J Rheumatol. 2005 Oct;32(10):1899-906.
    Results Reference
    background
    PubMed Identifier
    30691766
    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.
    Results Reference
    background
    PubMed Identifier
    30784788
    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.
    Results Reference
    background
    PubMed Identifier
    28807651
    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.
    Results Reference
    result

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    Efficacy of Myofascial Release in Patients With Axial Spondyloarthritis.

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