Meniscus InjuryNCT06309901
Facial Distortion Model and Instrument Assisted Soft Tissue Mobilization Techniques
An observational study of Meniscus Injury, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Meniscus Injury
- What is being tested?
- Exercise, Fascial Distortion Model and Instrument Assisted Soft Tissue Mobilisation
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2019to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Can not continue treatment for 4 weeks
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yıldırım Beyazıt University Yenimahalle Training and Research Hospital
Ankara, 06010
About this study
Official title: 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.
Read the 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.
- Conditions
- Meniscus Injury
- Being tested
- Exercise, Fascial Distortion Model, Instrument Assisted Soft Tissue Mobilisation
- Keywords
- IASTM, FDM, Meniscus repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
Fascial Distortion ModelOther
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.
Instrument Assisted Soft Tissue MobilisationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | A progressive home exercise program consisting of 3 phases was applied. Receives: Other: Exercise | |
| 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. Receives: Other: Exercise; Other: Fascial Distortion Model | |
| IASTM Group | In addition to the progressive home exercise program consisting of 3 phases, the IASTM was applied with Graston technique around the knee. Receives: Other: Exercise; Other: Instrument Assisted Soft Tissue Mobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
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.
Measured: Change from postoperative 4. week at 8. week
environmental measurement
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.
Measured: Change from postoperative 4. week at 8. week
Power Track Manuel Muscle Tester
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.
Measured: Change from postoperative 4. week at 8. week
sit and reach test
To reach the farthest in a sitting position.
Measured: Change from postoperative 4. week at 8. week
Goniometric measurement
uses a goniometer to measure the hamstring flexibility during a passive straight leg lift.
Measured: Change from postoperative 4. week at 8. week
The Western Ontario Meniscal Evaluation Tool (WOMET )
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.
Measured: Change from postoperative 4. week at 8. week
Lysholm Knee Score
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.
Measured: Change from postoperative 4. week at 8. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start30 Jun 2019
- Primary completion1 Dec 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Meniscus InjuryStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar Anaforoglu Külünkoglu, Ankara Yildirim Beyazıt University
- Investigators
- Bahar Anaforoğlu, Assoc. Prof., Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309901
- Sponsor's protocol ID
- ankaraYBU2019-199
- Status last verified
- Mar 2024
- First submitted
- 16 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: has not been decided yet.
Publications
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.
PubMed 27713575Kalichman 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.
PubMed 28532889Thalhamer 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.
PubMed 29332733
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Facial Distortion Model and Instrument Assisted Soft Tissue Mobilization (IASTM) Techniques After Arthroscopic Meniscus Repair
- ClinicalTrials.gov ID
- NCT06309901
- Acronym / sponsor ID
- ankaraYBU2019-199
- Conditions
- Meniscus Injury
- Keywords
- IASTM, FDM, Meniscus repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: ExerciseA progressive home exercise program consisting of 3 phases was applied. |
| FDM Group | – | Other: Exercise, Other: Fascial Distortion ModelIn 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. |
| IASTM Group | – | Other: Exercise, Other: Instrument Assisted Soft Tissue MobilisationIn addition to the progressive home exercise program consisting of 3 phases, the IASTM was applied with Graston technique around the knee. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (1 listed)
- Can not continue treatment for 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseHome 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 | Control Group, FDM Group, IASTM Group |
| Fascial Distortion ModelAt 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. | Other | FDM Group |
| Instrument Assisted Soft Tissue MobilisationAt 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. | Other | IASTM Group |
Primary outcome
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.
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.
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.
sit and reach test
Time frame: Change from postoperative 4. week at 8. week
To reach the farthest in a sitting position.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Results publication: PubMed 27713575Cheatham 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.
- Results publication: PubMed 28532889Kalichman 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.
- Results publication: PubMed 29332733Thalhamer 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.
- Individual participant dataSharing planned: Undecided. has not been decided yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bahar Anaforoğlu, Assoc. Prof. principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus Injury, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Change from postoperative 4. week at 8. week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06309901, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.