NCT06309901

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

2.4 years

First QC Date

February 16, 2024

Last Update Submit

March 12, 2024

Conditions

Keywords

IASTMFDMMeniscus repair

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • sit and reach test

    To reach the farthest in a sitting position.

    Change from postoperative 4. week at 8. week

  • Goniometric measurement

    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 )

    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

    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

Study Arms (3)

Control Group

A progressive home exercise program consisting of 3 phases was applied.

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.

Other: ExerciseOther: 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.

Other: ExerciseOther: Instrument Assisted Soft Tissue Mobilisation

Interventions

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.

Control GroupFDM GroupIASTM Group

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.

FDM Group

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.

IASTM Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Can not continue treatment for 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yıldırım Beyazıt University Yenimahalle Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Related 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.

  • 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.

  • 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.

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bahar Anaforoğlu, Assoc. Prof.

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

February 16, 2024

First Posted

March 13, 2024

Study Start

June 30, 2019

Primary Completion

December 1, 2021

Study Completion

May 31, 2022

Last Updated

March 13, 2024

Record last verified: 2024-03

Locations