Clinical trial NCT04424589: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Ankylosing Spondylitis
Lead sponsor: Universidad de la Sabana
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: 3 weeks
Secondary outcomes:
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: 3 Weeks
measure: El Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: 3 weeks
measure: ASQoL (Ankylosing Spondylitis Quality of Life)
timeFrame: 3 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de la Sabana
name: María Alejandra Sánchez Vera, PT
role: PRINCIPAL_INVESTIGATOR
References:
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: Dagfinrud H, Kvien TK, Hagen KB. The Cochrane review of physiotherapy interventions for ankylosing spondylitis. J Rheumatol. 2005 Oct;32(10):1899-906.
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: 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). 2019 Mar;63:27-33. doi: 10.1016/j.clinbiomech.2019.02.009. Epub 2019 Feb 14.
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.