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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06309901
Other study ID # ankaraYBU2019-199
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 30, 2019
Est. completion date May 31, 2022

Study information

Verified date March 2024
Source Ankara Yildirim Beyazit University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date May 31, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
Turkey Yildirim Beyazit University Yenimahalle Training and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from postoperative 4. week at 8. week
Primary 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. Change from postoperative 4. week at 8. week
Primary 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. Change from postoperative 4. week at 8. week
Primary sit and reach test To reach the farthest in a sitting position. Change from postoperative 4. week at 8. week
Primary Goniometric measurement uses a goniometer to measure the hamstring flexibility during a passive straight leg lift. Change from postoperative 4. week at 8. week
Primary 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. Change from postoperative 4. week at 8. week
Primary 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. Change from postoperative 4. week at 8. week
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