Facial Distortion Model and Instrument Assisted Soft Tissue Mobilization Techniques

March 12, 2024 updated by: Bahar Anaforoglu Külünkoglu, Ankara Yildirim Beyazıt University

Comparison of Facial Distortion Model and Instrument Assisted Soft Tissue Mobilization (IASTM) Techniques After Arthroscopic Meniscus Repair

To compare the effects of facial distortion model and equipment assisted soft tissue mobilization techniques on the treatment process, which are among the applications in the rehabilitation process after meniscus repair.

Study Overview

Status

Status

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

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

It is possible that pain, ROM, lower extremity flexibility and knee functions will be negatively affected after arthroscopic meniscus repair. This study searches and compares the effectiveness of fascial distortion model (FDM) and IASTM methods for these parameters that can be affected.

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.
Observational

Enrollment (Actual)

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.
33

Contacts and Locations

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

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Yıldırım Beyazıt University Yenimahalle Training and Research Hospital

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Individuals who were diagnosed after meniscus tear between 18-55 years and suspected magnetic resonance (MRI) or operated during arthroscopy and operated by the surgeon, will be included in the study.

Description

Inclusion Criteria:

  • The meniscus rupture and suspected magnetic resonance (MR) were diagnosed and operated by the surgeon during arthroscopy.
  • Those treated with the same surgical technique
  • Can walk independently before the operation
  • Can continue treatment for 4 weeks
  • Without chondral damage
  • Can continue treatment for 4 weeks
  • Those who have not had lower extremity surgery before
  • No fracture to prevent load transfer in the last 6 months
  • There is no full rupture of any ligament in the knee
  • Without knee instability
  • Those without abnormal changes in Q angle
  • According to Cooper classification, meniscus affected area is not in A and F regions.
  • Without protruded or extruded herniated disc
  • There is no contract in the directory

Exclusion Criteria:

  • Can not continue treatment for 4 weeks

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Control Group
A progressive home exercise program consisting of 3 phases was applied.
Other: Exercise

Home exercises were applied in 3 progressive phases.

1st phase: postoperative 0-4. week, 2nd phase: 5-12. week, 3rd phase 12-15. week.

In the 1st phase, ice application, strengthening for the hip, knee and ankle, and walking exercises were applied. 90 degrees knee flexion range of movement (ROM) was targeted.

In the 2nd phase, the resistance of the strengthening exercises was increased and closed kinetic chain exercises were added. Weight bearing, step climbing and balance exercises were performed. Full ROM targeted in the knee.

In the 3rd phase, pain-free full ROM was targeted, and progressive strengthening, balance and agility exercises for sports and recreational activities were applied.
FDM Group
In addition to the progressive home exercise program consisting of 3 phases, the trigger band technique of the fascial distortion model was applied around the knee.
Other: Exercise

Home exercises were applied in 3 progressive phases.

1st phase: postoperative 0-4. week, 2nd phase: 5-12. week, 3rd phase 12-15. week.

In the 1st phase, ice application, strengthening for the hip, knee and ankle, and walking exercises were applied. 90 degrees knee flexion range of movement (ROM) was targeted.

In the 2nd phase, the resistance of the strengthening exercises was increased and closed kinetic chain exercises were added. Weight bearing, step climbing and balance exercises were performed. Full ROM targeted in the knee.

In the 3rd phase, pain-free full ROM was targeted, and progressive strengthening, balance and agility exercises for sports and recreational activities were applied.

Other: Fascial Distortion Model

At the beginning of the 2nd phase of the treatment, starting from the 5th week, twice a week for 4 weeks, a total of 8 sessions of FDM technique were applied.

In this study, trigger band technique was chosen to apply around the knee. Interventions were made directly to the skin in the form of medial, lateral, anterior, posterior techniques of the knee and posterior and lateral techniques of the thigh. The techniques was made after the exercises.
IASTM Group
In addition to the progressive home exercise program consisting of 3 phases, the IASTM was applied with Graston technique around the knee.
Other: Exercise

Home exercises were applied in 3 progressive phases.

1st phase: postoperative 0-4. week, 2nd phase: 5-12. week, 3rd phase 12-15. week.

In the 1st phase, ice application, strengthening for the hip, knee and ankle, and walking exercises were applied. 90 degrees knee flexion range of movement (ROM) was targeted.

In the 2nd phase, the resistance of the strengthening exercises was increased and closed kinetic chain exercises were added. Weight bearing, step climbing and balance exercises were performed. Full ROM targeted in the knee.

In the 3rd phase, pain-free full ROM was targeted, and progressive strengthening, balance and agility exercises for sports and recreational activities were applied.

Other: Instrument Assisted Soft Tissue Mobilisation

At the beginning of the 2nd phase of the treatment, starting from the 5th week, twice a week for 4 weeks, a total of 8 sessions of IASTM technique were applied.

In this study, the Graston technique was chosen to apply IASTM around the knee. Technique was applied with using stainless steel and ultrasound gel to around the knee, m. quadriceps, m. hamstring, iliotibial band and medial thigh. The technique was performed for at least 2 minutes in each region.

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
Visual Analog Scale
Time Frame: Change from postoperative 4. week at 8. week
It is used to convert some values that cannot be measured numerically into numerical values. Two end definitions of the parameter to be evaluated on both ends of a 100 mm line are written and the patient is asked to indicate where his / her condition is appropriate on this line by drawing a line or by marking or pointing.
Change from postoperative 4. week at 8. week
environmental measurement
Time Frame: Change from postoperative 4. week at 8. week
One of the anthropometric measurement techniques is measured using tape measure. Medial tibial plateau and 5 cm intervals at 5 cm, 10 cm and 15 cm points are marked and the circumference of the knee and the leg is measured.
Change from postoperative 4. week at 8. week
Power Track Manuel Muscle Tester
Time Frame: Change from postoperative 4. week at 8. week
In the manual muscle test, a hand dynamometer was developed for the standardization of the given resistance, which determines the resistance given by the tester. This tool objectively shows the amount of force used in muscle testing. The tool is placed proximal to the tibia, the amount of force applied is read from the manometer on the dorsal side of the hand. It is placed on the front for extension and on the back for flexion.
Change from postoperative 4. week at 8. week
sit and reach test
Time Frame: Change from postoperative 4. week at 8. week
To reach the farthest in a sitting position.
Change from postoperative 4. week at 8. week
Goniometric measurement
Time Frame: Change from postoperative 4. week at 8. week
uses a goniometer to measure the hamstring flexibility during a passive straight leg lift.
Change from postoperative 4. week at 8. week
The Western Ontario Meniscal Evaluation Tool (WOMET )
Time Frame: Change from postoperative 4. week at 8. week
In this inventory, there are 16 items that represent physical domains (nine items), sports / entertainment / work / lifestyle (four items) and the domains of emotions (three items). A value between 0-10 is requested in each item. The score of each subgroup is obtained by dividing the marked values of the questions of that section by the number of questions and multiplying by 10. The total score is obtained by summing all scores and dividing by 16 and multiplying by 10.
Change from postoperative 4. week at 8. week
Lysholm Knee Score
Time Frame: Change from postoperative 4. week at 8. week
It is a scoring questioning situations such as pain, stair climbing, squatting, walking pattern and swelling of the knee while showing certain activities. In the Lysholm scoring system; It can be classified as 0-20 bad, 21-40 medium, 41-60 medium-good, 61-80 good, 81-100 perfect.
Change from postoperative 4. week at 8. week

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.
Ankara Yildirim Beyazıt University

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: Bahar Anaforoğlu, Assoc. Prof., Ankara Yildirim Beyazıt University

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 (Actual)

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.
June 30, 2019

Primary Completion (Actual)

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.
December 1, 2021

Study Completion (Actual)

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.
May 31, 2022

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).
February 16, 2024

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.
March 12, 2024

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.
March 13, 2024

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.
March 13, 2024

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.
March 12, 2024

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.
March 1, 2024

More Information

Terms related to this study

Keywords

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.
  • ankaraYBU2019-199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

has not been decided yet.

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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