- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06309901
Facial Distortion Model and Instrument Assisted Soft Tissue Mobilization Techniques
Comparison of Facial Distortion Model and Instrument Assisted Soft Tissue Mobilization (IASTM) Techniques After Arthroscopic Meniscus Repair
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06010
- Yıldırım Beyazıt University Yenimahalle Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control Group
A progressive home exercise program consisting of 3 phases was applied.
|
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.
|
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. 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.
|
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. 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
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
Investigators
- Principal Investigator: Bahar Anaforoğlu, Assoc. Prof., Ankara Yildirim Beyazıt University
Publications and helpful links
General Publications
- Kalichman L, Ben David C. Effect of self-myofascial release on myofascial pain, muscle flexibility, and strength: A narrative review. J Bodyw Mov Ther. 2017 Apr;21(2):446-451. doi: 10.1016/j.jbmt.2016.11.006. Epub 2016 Nov 14.
- Cheatham SW, Lee M, Cain M, Baker R. The efficacy of instrument assisted soft tissue mobilization: a systematic review. J Can Chiropr Assoc. 2016 Sep;60(3):200-211.
- Thalhamer C. A fundamental critique of the fascial distortion model and its application in clinical practice. J Bodyw Mov Ther. 2018 Jan;22(1):112-117. doi: 10.1016/j.jbmt.2017.07.009. Epub 2017 Jul 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ankaraYBU2019-199
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Meniscus Injury
-
Eskisehir Osmangazi UniversityThe Scientific and Technological Research Council of TurkeyRecruitingArthralgia | Knee Injuries | Meniscus; Degeneration | Knee Pain Swelling | Meniscus Lesion | Meniscus Tear | Knee; Injury, Meniscus (Lateral) (Medial) | Meniscus; Laceration | Meniscus Injury, TibialTurkey
-
Peking University Third HospitalRecruiting
-
Tongji HospitalChinese Academy of SciencesUnknown
-
FUJIFILM Toyama Chemical Co., Ltd.Active, not recruiting
-
University Hospital, LinkoepingCompletedChronic Meniscus InjurySweden
-
Austin V StoneTerminatedAnterior Cruciate Ligament Tear | Tibial Meniscus Injuries | Tibial Meniscus Tears | Tibial Meniscus, TornUnited States
-
Austin V StoneTerminatedCartilage Injury | Meniscus Lesion | Meniscus TearUnited States
-
eMKa MED Medical CenterWroclaw Medical UniversityRecruitingMeniscus; Detachment, Current Injury | Detachment | Medial Mensical Tear | Medial Meniscus Knee InjuryPoland
-
NYU Langone HealthRecruitingMeniscus; Detachment, Current InjuryUnited States
-
Istituto Ortopedico RizzoliRecruitingMeniscus Lesion | Meniscus Disorder | ACL InjuriesItaly
Clinical Trials on Exercise
-
University of Kansas Medical CenterRecruiting
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
University College CorkRecruitingDepressive Disorder, MajorIreland
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of
-
University of AlbertaWomen and Children's Health Research Institute, CanadaRecruitingType 1 Diabetes | Post-menopauseCanada
-
Uskudar UniversityCompleted
-
Yuksek Ihtisas UniversityCompletedDementia | Frailty | Cognitive Function | Reaction Time | Aerobic Exercise | Balance ExerciseTurkey
-
National Taiwan Normal UniversityCompletedAging | Cognitive DeclineTaiwan