Efficacy of Myofascial Release in Patients With Axial Spondyloarthritis.

NCT04424589 | Unknown

• 1 other identifier: EPI-01-2020
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Bath Ankylosing Spondylitis Functional Index (BASFI)

  3 Weeks

• El Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  3 weeks

• ASQoL (Ankylosing Spondylitis Quality of Life)

  3 Weeks

Study Arms (2)

Myofascial release

EXPERIMENTAL

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.

Other: Myofascial release

Sham Therapy

SHAM COMPARATOR

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.

Other: Sham therapy

Interventions

Myofascial release OTHER

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.

Myofascial release

Sham therapy OTHER

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.

Sham Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de la Sabana: lead

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 30784788 BACKGROUND

• 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 RESULT

• Sanchez Vera MA, Jaimes Fernandez DA, Schleip R. Efficacy of myofascial induction compared with its simulation on joint amplitude in people with axial spondylarthritis: Protocol of a randomized controlled clinical trial. PLoS One. 2023 Oct 5;18(10):e0286885. doi: 10.1371/journal.pone.0286885. eCollection 2023.

  PMID: 37796870 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• María Alejandra Sánchez Vera, PT

  Universidad de la Sabana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María Alejandra Sánchez Vera

CONTACT

+573115162235; Mariasanver@unisabana.edu.co

Diego Alejandro Jaimes Fernández

CONTACT

diegojf@unisabana.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: June 11, 2020
• Study Start: December 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share