Efficacy of Myofascial Release in Patients With Axial Spondyloarthritis.

U

Universidad de la Sabana

Status

Unknown

Conditions

Ankylosing Spondylitis

Treatments

Other: Sham therapy
Other: Myofascial release

Study type

Interventional

Funder types

Other

Identifiers

NCT04424589
EPI-01-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

82 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

82 participants in 2 patient groups

Myofascial release
Experimental group
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.
Treatment:
Other: Myofascial release
Sham Therapy
Sham Comparator group
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.
Treatment:
Other: Sham therapy

Trial contacts and locations

0

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Central trial contact

Diego Alejandro Jaimes Fernández; María Alejandra Sánchez Vera

Data sourced from clinicaltrials.gov

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