Efficacy of Myofascial Release in Patients With Axial Spondyloarthritis.

Ankylosing Spondylitis Clinical Trial

Official title:

Efficacy of Myofascial Release Compared With Sham Therapy on Joint Range of Motion in Patients With Axial Spondyloarthritis.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04424589
• Other study ID #: EPI-01-2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: June 2021

Study information

• Verified date: June 2020
• Source: Universidad de la Sabana
• Contact: María Alejandra Sánchez Vera
• Phone: +573115162235
• Email: Mariasanver[@]unisabana.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: June 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• Myofascial release
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.
• Sham therapy
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de la Sabana

References & Publications (5)

Arguisuelas MD, Lisón JF, Doménech-Fernández J, Martínez-Hurtado I, Salvador Coloma P, Sánchez-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. — View 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. — View Citation

Dagfinrud H, Kvien TK, Hagen KB. The Cochrane review of physiotherapy interventions for ankylosing spondylitis. J Rheumatol. 2005 Oct;32(10):1899-906. Review. — View Citation

Flórez García MT, Carmona L, Almodóvar R, Fernández de Las Peñas C, García Pérez F, Pérez Manzanero MÁ, García García JM, Soriano Segarra L, Jiménez Díaz JF, Mendoza Laiz N, de Miguel Mendieta E, Torre Alonso JC, Linares Ferrando LF, Collantes Estévez E, — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks
Secondary	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.	3 Weeks
Secondary	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.	3 weeks
Secondary	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	3 Weeks