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Effect of Eswt on Muscle Architecture

Primary Purpose

Tendinopathy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Extracorporeal shockwave theraphy for hamstring tendinopathy
Extracorporeal shockwave theraphy for quadriceps tendinopathy
Extracorporeal shockwave theraphy for achilles tendinopathy
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring Extracorporeal shockwave theraphy, Ultrasonography, muscle strength

Eligibility Criteria

21 Years - 52 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Lower extremity tendinopathy

Exclusion Criteria:

  • Patients who failed to show up to any treatment and measurement sessions,
  • Patients who cannot tolerate treatment
  • having systemic inflammatory disease,
  • lower or upper motor lesion

Sites / Locations

  • Gaziantep Private Hatem HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tendinopathy patients

Arm Description

Patients with tendinopathy will be administered ESWT

Outcomes

Primary Outcome Measures

muscle pannation angle
'Logiq s7 Expert' US device including b-flow, semi-quantification and elastography, flow quantification, contrast imaging, b-steer and volume imaging device and with 11 L-D linear volume convex and linear probe will use for the measurements. During the evaluation, the muscles will place in the most relaxed position and no contraction will request. Pennation angle will measure as the angle between muscle fibre and the deep fascia of the muscle
muscle fiber length
'Logiq s7 Expert' US device including b-flow, semi-quantification and elastography, flow quantification, contrast imaging, b-steer and volume imaging device and with 11 L-D linear volume convex and linear probe will use for the measurements. During the evaluation, the muscles will place in the most relaxed position and no contraction will request. Fiber length will measure as the length of the fascicular path between the superficial and deep aponeurosis. For the measuring of the fiber length , the most clearly measure areas will be taken into consideration. If the fascicle extended off the image, the missing portion will estimate via linear extrapolation of the fascicle and aponeurosis
muscle thickness
'Logiq s7 Expert' US device including b-flow, semi-quantification and elastography, flow quantification, contrast imaging, b-steer and volume imaging device and with 11 L-D linear volume convex and linear probe will use for the measurements. During the evaluation, the muscles will place in the most relaxed position and no contraction will reques thickness will measure in transversal as the distance between the superficial and the deep fascia at distance

Secondary Outcome Measures

Quadriceps muscle flexibility
The Ely's test will use for the measurement. The procedure will modify to incorporate active knee flexion (rather than passive knee flexion) into the testing protocol in order to facilitate goniometer measurement by only one examiner. Participants will instruct to actively flex one knee and bring their heel towards the buttocks, while maintaining a neutral pelvic posture and contact of the anterior aspect of the hip with the plinth.Goniometric scores will be taken in degrees
Hamstring muscle flexibility
Flexibility of the muscles will be measured with using tape measure. A single measurement will be performed for each muscle. The muscle flexibility will record as centimeters (cm).The passive straight leg raise (PSLR) test will perform to assess the hamstring muscle flexibility. The subjects will lay supine with their legs will straight on an examining bed. The ankle of the testing leg will keep in a relaxed position throughout testing. The endpoint for the PSLR test will determine by the following two criteria: (i) the tightness felt by the examiner and (ii) the onset of pain in the hamstring reported by subject. Evaluation will do according to the angle on the hip. The scores will measure by tape measure. The distance between calcaneus and the floor will record.
Gastrocinemius muscle flexibility
The lunge test will use for gastrocinemius. The patient will stand against the wall so that the distance between the foot and the wall is about 10 cm long. They will move one foot back a foot's distance behind the other. They will bend the front knee until it will touch the wall (keeping the heel on ground). If knee can not touch wall without heel coming off ground, the foot will be moved closer to wall and then will be repeated. If knee can touch wall without heel coming off ground, the foot will be moved further away from wall and then will be repeated. Keep will be repeated step 5 until can just touch knee to wall and heel stays on ground.The flexion lunge will be measured the distance length in centimeters (to the nearest O.lcm) from the end of the big toe to the wall using a tape measure on the floor .
Quadriceps muscle strength
Powertrak Hand-Held Dynamometer (JTech Medical, Utah, USA) digital dynamometer will use for assessing the muscle strength.The muscle strength will record as Newtons.Providing verbal encouragement to use their maximum efforts, the patients will ask to apply forces to the dynamometer during a period of 5 to 10 seconds while patients will sitting in a fixed chair and the examiner's hand pressed down the thigh to the chair.
hamstring muscle strength
Powertrak Hand-Held Dynamometer (JTech Medical, Utah, USA) digital dynamometer will use for assessing the muscle strength.The muscle strength will record as Newtons.. For the hamstring muscle, isometric knee flexion strength will measure with the subject in a prone position and the pelvis and the contralateral leg will be fixed. The dynamometer will place at the ankle, perpendicular to the lower leg. The foot will in plantar flexion and the knee in an extended position. Three maximal voluntary isometric knee flexion contractions will ask with gradually increasing effort
gastrokinemius muscle strength
Powertrak Hand-Held Dynamometer (JTech Medical, Utah, USA) digital dynamometer will use for assessing the muscle strength.The muscle strength will record as Newtons. All subjects will be performed the isometric contractions in a prone position on the table with the hip and knee extended and the foot in neutral position.

Full Information

First Posted
May 11, 2020
Last Updated
February 15, 2021
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04410705
Brief Title
Effect of Eswt on Muscle Architecture
Official Title
Investigation the Effect of the Extracorporeal Shock Wave Therapy on Muscle Strength, Flexibility and Architectural Features in Lower Extremity Tendinopathies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 11, 2020 (Actual)
Primary Completion Date
July 5, 2020 (Actual)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the research is to investigate the effect of Ekstracorpereal shock wave treatment (ESWT) on muscle strength, flexibility and architecture of the lower extremity tendinopathies when applied using the frequencies specified in the literature with min and max frequency frequencies. Our hypothesis as researchers is ESWT treatment has an effect on muscle strength, flexibility and muscle architecture.
Detailed Description
The study will conduct in the Physical Therapy and Radiology Department in a private hospital. The Clinical Research Ethics Committee of Gaziantep the univsersity approved ethical compliance of the study with the decision number GO 2018-01. The participants will inform about the study and their write consent will obtain. Demographic information including the name, age, height, body weight and occupation of the participants will obtain before the evaluation. All the measurements will perform before, soon after the 1st session and after the last session. Outcome measures will be muscle strength, muscle flexibility, muscle architectures parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
Extracorporeal shockwave theraphy, Ultrasonography, muscle strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
ESWT
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tendinopathy patients
Arm Type
Experimental
Arm Description
Patients with tendinopathy will be administered ESWT
Intervention Type
Other
Intervention Name(s)
Extracorporeal shockwave theraphy for hamstring tendinopathy
Intervention Description
For hamstring tendinopathy; a total of 2000 impulses will be done. We will apply twice a week and 5 times in total.
Intervention Type
Other
Intervention Name(s)
Extracorporeal shockwave theraphy for quadriceps tendinopathy
Intervention Description
Energy flux density will be 0.58mJ/mm2 (2 bar) with 2000 impulses. We will perform twice a week, 5 times in total.
Intervention Type
Other
Intervention Name(s)
Extracorporeal shockwave theraphy for achilles tendinopathy
Intervention Description
Each session consisted of 2400 impulses will be administered with an energy flux density ranged from 0.17 to 0.25 mJ/mm2 (1.7-2.5 bar). We will perform once a week, 3 times in total.
Primary Outcome Measure Information:
Title
muscle pannation angle
Description
'Logiq s7 Expert' US device including b-flow, semi-quantification and elastography, flow quantification, contrast imaging, b-steer and volume imaging device and with 11 L-D linear volume convex and linear probe will use for the measurements. During the evaluation, the muscles will place in the most relaxed position and no contraction will request. Pennation angle will measure as the angle between muscle fibre and the deep fascia of the muscle
Time Frame
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment. Change of pannation angle in 3 weeks
Title
muscle fiber length
Description
'Logiq s7 Expert' US device including b-flow, semi-quantification and elastography, flow quantification, contrast imaging, b-steer and volume imaging device and with 11 L-D linear volume convex and linear probe will use for the measurements. During the evaluation, the muscles will place in the most relaxed position and no contraction will request. Fiber length will measure as the length of the fascicular path between the superficial and deep aponeurosis. For the measuring of the fiber length , the most clearly measure areas will be taken into consideration. If the fascicle extended off the image, the missing portion will estimate via linear extrapolation of the fascicle and aponeurosis
Time Frame
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment.Change of fiber length in 3 weeks
Title
muscle thickness
Description
'Logiq s7 Expert' US device including b-flow, semi-quantification and elastography, flow quantification, contrast imaging, b-steer and volume imaging device and with 11 L-D linear volume convex and linear probe will use for the measurements. During the evaluation, the muscles will place in the most relaxed position and no contraction will reques thickness will measure in transversal as the distance between the superficial and the deep fascia at distance
Time Frame
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment.Change of thickness in 3 weeks
Secondary Outcome Measure Information:
Title
Quadriceps muscle flexibility
Description
The Ely's test will use for the measurement. The procedure will modify to incorporate active knee flexion (rather than passive knee flexion) into the testing protocol in order to facilitate goniometer measurement by only one examiner. Participants will instruct to actively flex one knee and bring their heel towards the buttocks, while maintaining a neutral pelvic posture and contact of the anterior aspect of the hip with the plinth.Goniometric scores will be taken in degrees
Time Frame
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment.Change of flexibility in 3 weeks
Title
Hamstring muscle flexibility
Description
Flexibility of the muscles will be measured with using tape measure. A single measurement will be performed for each muscle. The muscle flexibility will record as centimeters (cm).The passive straight leg raise (PSLR) test will perform to assess the hamstring muscle flexibility. The subjects will lay supine with their legs will straight on an examining bed. The ankle of the testing leg will keep in a relaxed position throughout testing. The endpoint for the PSLR test will determine by the following two criteria: (i) the tightness felt by the examiner and (ii) the onset of pain in the hamstring reported by subject. Evaluation will do according to the angle on the hip. The scores will measure by tape measure. The distance between calcaneus and the floor will record.
Time Frame
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment..Change of flexibility in 3 weeks
Title
Gastrocinemius muscle flexibility
Description
The lunge test will use for gastrocinemius. The patient will stand against the wall so that the distance between the foot and the wall is about 10 cm long. They will move one foot back a foot's distance behind the other. They will bend the front knee until it will touch the wall (keeping the heel on ground). If knee can not touch wall without heel coming off ground, the foot will be moved closer to wall and then will be repeated. If knee can touch wall without heel coming off ground, the foot will be moved further away from wall and then will be repeated. Keep will be repeated step 5 until can just touch knee to wall and heel stays on ground.The flexion lunge will be measured the distance length in centimeters (to the nearest O.lcm) from the end of the big toe to the wall using a tape measure on the floor .
Time Frame
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment..Change of flexibility in 3 weeks
Title
Quadriceps muscle strength
Description
Powertrak Hand-Held Dynamometer (JTech Medical, Utah, USA) digital dynamometer will use for assessing the muscle strength.The muscle strength will record as Newtons.Providing verbal encouragement to use their maximum efforts, the patients will ask to apply forces to the dynamometer during a period of 5 to 10 seconds while patients will sitting in a fixed chair and the examiner's hand pressed down the thigh to the chair.
Time Frame
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment..Change of strength in 3 weeks
Title
hamstring muscle strength
Description
Powertrak Hand-Held Dynamometer (JTech Medical, Utah, USA) digital dynamometer will use for assessing the muscle strength.The muscle strength will record as Newtons.. For the hamstring muscle, isometric knee flexion strength will measure with the subject in a prone position and the pelvis and the contralateral leg will be fixed. The dynamometer will place at the ankle, perpendicular to the lower leg. The foot will in plantar flexion and the knee in an extended position. Three maximal voluntary isometric knee flexion contractions will ask with gradually increasing effort
Time Frame
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment. Change of strength in 3 weeks
Title
gastrokinemius muscle strength
Description
Powertrak Hand-Held Dynamometer (JTech Medical, Utah, USA) digital dynamometer will use for assessing the muscle strength.The muscle strength will record as Newtons. All subjects will be performed the isometric contractions in a prone position on the table with the hip and knee extended and the foot in neutral position.
Time Frame
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment.Change of strength in 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lower extremity tendinopathy Exclusion Criteria: Patients who failed to show up to any treatment and measurement sessions, Patients who cannot tolerate treatment having systemic inflammatory disease, lower or upper motor lesion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tüzün FIRAT, Associate professor
Phone
+90 532 671 06 35
Email
tuzun75@gmail.com
Facility Information:
Facility Name
Gaziantep Private Hatem Hospital
City
Gaziantep
ZIP/Postal Code
27000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
aydan niziplioğlu, MSc
Phone
05324132734
Email
fzt.niziplioglu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Eswt on Muscle Architecture

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