Effect of Eswt on Muscle Architecture

February 15, 2021 updated by: Aydan Niziplioğlu, Hacettepe University

Investigation the Effect of the Extracorporeal Shock Wave Therapy on Muscle Strength, Flexibility and Architectural Features in Lower Extremity Tendinopathies

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tüzün FIRAT, Associate professor
  • Phone Number: +90 532 671 06 35
  • Email: tuzun75@gmail.com

Study Locations

  • Turkey
      • Gaziantep, Turkey, 27000
        • Recruiting
        • Gaziantep Private Hatem Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 52 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tendinopathy patients
Patients with tendinopathy will be administered ESWT
Other: Extracorporeal shockwave theraphy for hamstring tendinopathy
For hamstring tendinopathy; a total of 2000 impulses will be done. We will apply twice a week and 5 times in total.
Other: Extracorporeal shockwave theraphy for quadriceps tendinopathy
Energy flux density will be 0.58mJ/mm2 (2 bar) with 2000 impulses. We will perform twice a week, 5 times in total.
Other: Extracorporeal shockwave theraphy for achilles tendinopathy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle pannation angle
Time Frame: Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment. Change of pannation angle in 3 weeks
'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
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment. Change of pannation angle in 3 weeks
muscle fiber length
Time Frame: Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment.Change of fiber length in 3 weeks
'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
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment.Change of fiber length in 3 weeks
muscle thickness
Time Frame: Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment.Change of thickness in 3 weeks
'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
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment.Change of thickness in 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quadriceps muscle flexibility
Time Frame: Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment.Change of flexibility in 3 weeks
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
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment.Change of flexibility in 3 weeks
Hamstring muscle flexibility
Time Frame: Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment..Change of flexibility in 3 weeks
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.
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment..Change of flexibility in 3 weeks
Gastrocinemius muscle flexibility
Time Frame: Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment..Change of flexibility in 3 weeks

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 .
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment..Change of flexibility in 3 weeks
Quadriceps muscle strength
Time Frame: Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment..Change of strength in 3 weeks
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.
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment..Change of strength in 3 weeks
hamstring muscle strength
Time Frame: Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment. Change of strength in 3 weeks
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
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment. Change of strength in 3 weeks
gastrokinemius muscle strength
Time Frame: Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment.Change of strength in 3 weeks
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.
Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment.Change of strength in 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2020

Primary Completion (Actual)

July 5, 2020

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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