Effect of Eswt on Muscle Architecture

Sponsor
Hacettepe University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04410705
Collaborator
(none)
20
1
1
15.7
1.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Extracorporeal shockwave theraphy for hamstring tendinopathy
  • Other: Extracorporeal shockwave theraphy for quadriceps tendinopathy
  • Other: Extracorporeal shockwave theraphy for achilles tendinopathy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
ESWTESWT
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigation the Effect of the Extracorporeal Shock Wave Therapy on Muscle Strength, Flexibility and Architectural Features in Lower Extremity Tendinopathies
Actual Study Start Date :
May 11, 2020
Actual Primary Completion Date :
Jul 5, 2020
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. muscle pannation angle [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

  2. muscle fiber length [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

  3. muscle thickness [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

Secondary Outcome Measures

  1. Quadriceps muscle flexibility [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

  2. Hamstring muscle flexibility [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.

  3. Gastrocinemius muscle flexibility [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 .

  4. Quadriceps muscle strength [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.

  5. hamstring muscle strength [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

  6. gastrokinemius muscle strength [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 52 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gaziantep Private Hatem Hospital Gaziantep Turkey 27000

Sponsors and Collaborators

  • Hacettepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Aydan Niziplioğlu, MSc. physiotherapist, Hacettepe University
ClinicalTrials.gov Identifier:
NCT04410705
Other Study ID Numbers:
  • 2018-01
First Posted:
Jun 1, 2020
Last Update Posted:
Feb 16, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aydan Niziplioğlu, MSc. physiotherapist, Hacettepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2021