Efficacy of Myofascial Release in Patients With Axial Spondyloarthritis.

June 6, 2020 updated by: Universidad de la Sabana

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Myofascial release

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
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 Comparator: Sham Therapy
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time Frame: 3 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: 3 Weeks
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
El Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: 3 weeks
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
ASQoL (Ankylosing Spondylitis Quality of Life)
Time Frame: 3 Weeks
It consists of 18 questions, with the possibility of a dichotomous answer (Yes-No) The global score ranges from 0 to 18
3 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de la Sabana

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: María Alejandra Sánchez Vera, PT, Universidad de La Sabana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EPI-01-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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