NCT04410705

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 11, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

May 11, 2020

Last Update Submit

February 15, 2021

Conditions

Keywords

Extracorporeal shockwave theraphyUltrasonographymuscle strength

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    '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

    '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 Outcomes (6)

  • Quadriceps muscle flexibility

    Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment.Change of flexibility in 3 weeks

  • Hamstring muscle flexibility

    Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment..Change of flexibility in 3 weeks

  • Gastrocinemius muscle flexibility

    Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment..Change of flexibility in 3 weeks

  • Quadriceps muscle strength

    Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment..Change of strength in 3 weeks

  • hamstring muscle strength

    Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment. Change of strength in 3 weeks

  • +1 more secondary outcomes

Study Arms (1)

Tendinopathy patients

EXPERIMENTAL

Patients with tendinopathy will be administered ESWT

Other: Extracorporeal shockwave theraphy for hamstring tendinopathyOther: Extracorporeal shockwave theraphy for quadriceps tendinopathyOther: Extracorporeal shockwave theraphy for achilles tendinopathy

Interventions

For hamstring tendinopathy; a total of 2000 impulses will be done. We will apply twice a week and 5 times in total.

Tendinopathy patients

Energy flux density will be 0.58mJ/mm2 (2 bar) with 2000 impulses. We will perform twice a week, 5 times in total.

Tendinopathy patients

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.

Tendinopathy patients

Eligibility Criteria

Age21 Years - 52 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep Private Hatem Hospital

Gaziantep, 27000, Turkey (Türkiye)

RECRUITING

Related Publications (18)

  • Atamaz F, Ozcaldiran B, Ozdedeli S, Capaci K, Durmaz B. Interobserver and intraobserver reliability in lower-limb flexibility measurements. J Sports Med Phys Fitness. 2011 Dec;51(4):689-94.

    PMID: 22212274BACKGROUND
  • Shechtman O, Gestewitz L, Kimble C. Reliability and validity of the DynEx dynamometer. J Hand Ther. 2005 Jul-Sep;18(3):339-47. doi: 10.1197/j.jht.2005.04.002.

    PMID: 16059855BACKGROUND
  • English C, Fisher L, Thoirs K. Reliability of real-time ultrasound for measuring skeletal muscle size in human limbs in vivo: a systematic review. Clin Rehabil. 2012 Oct;26(10):934-44. doi: 10.1177/0269215511434994. Epub 2012 Feb 9.

    PMID: 22324054BACKGROUND
  • Strasser EM, Draskovits T, Praschak M, Quittan M, Graf A. Association between ultrasound measurements of muscle thickness, pennation angle, echogenicity and skeletal muscle strength in the elderly. Age (Dordr). 2013 Dec;35(6):2377-88. doi: 10.1007/s11357-013-9517-z. Epub 2013 Mar 2.

    PMID: 23456136BACKGROUND
  • Valle MS, Casabona A, Micale M, Cioni M. Relationships between Muscle Architecture of Rectus Femoris and Functional Parameters of Knee Motion in Adults with Down Syndrome. Biomed Res Int. 2016;2016:7546179. doi: 10.1155/2016/7546179. Epub 2016 Nov 8.

    PMID: 27896273BACKGROUND
  • Vetrano M, d'Alessandro F, Torrisi MR, Ferretti A, Vulpiani MC, Visco V. Extracorporeal shock wave therapy promotes cell proliferation and collagen synthesis of primary cultured human tenocytes. Knee Surg Sports Traumatol Arthrosc. 2011 Dec;19(12):2159-68. doi: 10.1007/s00167-011-1534-9. Epub 2011 May 27.

    PMID: 21617986BACKGROUND
  • Kim YW, Chang WH, Kim NY, Kwon JB, Lee SC. Effect of Extracorporeal Shock Wave Therapy on Hamstring Tightness in Healthy Subjects: A Pilot Study. Yonsei Med J. 2017 May;58(3):644-649. doi: 10.3349/ymj.2017.58.3.644.

    PMID: 28332373BACKGROUND
  • Erroi D, Sigona M, Suarez T, Trischitta D, Pavan A, Vulpiani MC, Vetrano M. Conservative treatment for Insertional Achilles Tendinopathy: platelet-rich plasma and focused shock waves. A retrospective study. Muscles Ligaments Tendons J. 2017 May 10;7(1):98-106. doi: 10.11138/mltj/2017.7.1.098. eCollection 2017 Jan-Mar.

    PMID: 28717617BACKGROUND
  • Zwerver J, Verhagen E, Hartgens F, van den Akker-Scheek I, Diercks RL. The TOPGAME-study: effectiveness of extracorporeal shockwave therapy in jumping athletes with patellar tendinopathy. Design of a randomised controlled trial. BMC Musculoskelet Disord. 2010 Feb 8;11:28. doi: 10.1186/1471-2474-11-28.

    PMID: 20144188BACKGROUND
  • Askling C, Saartok T, Thorstensson A. Type of acute hamstring strain affects flexibility, strength, and time to return to pre-injury level. Br J Sports Med. 2006 Jan;40(1):40-4. doi: 10.1136/bjsm.2005.018879.

    PMID: 16371489BACKGROUND
  • Ozbek EA, Kalem M, Kinik H. Do the Loss of Thigh Muscle Strength and Tibial Malrotation Cause Anterior Knee Pain after Tibia Intramedullary Nailing? Biomed Res Int. 2019 Mar 27;2019:3072105. doi: 10.1155/2019/3072105. eCollection 2019.

    PMID: 31032341BACKGROUND
  • Arya S, Kulig K. Tendinopathy alters mechanical and material properties of the Achilles tendon. J Appl Physiol (1985). 2010 Mar;108(3):670-5. doi: 10.1152/japplphysiol.00259.2009. Epub 2009 Nov 5.

    PMID: 19892931BACKGROUND
  • Miyamoto N, Hirata K, Kimura N, Miyamoto-Mikami E. Contributions of Hamstring Stiffness to Straight-Leg-Raise and Sit-and-Reach Test Scores. Int J Sports Med. 2018 Feb;39(2):110-114. doi: 10.1055/s-0043-117411. Epub 2017 Nov 30.

    PMID: 29190853BACKGROUND
  • Massey G, Evangelidis P, Folland J. Influence of contractile force on the architecture and morphology of the quadriceps femoris. Exp Physiol. 2015 Nov;100(11):1342-51. doi: 10.1113/EP085360. Epub 2015 Oct 14.

    PMID: 26374174BACKGROUND
  • Turton P, Hay R, Taylor J, McPhee J, Welters I. Human limb skeletal muscle wasting and architectural remodeling during five to ten days intubation and ventilation in critical care - an observational study using ultrasound. BMC Anesthesiol. 2016 Nov 29;16(1):119. doi: 10.1186/s12871-016-0269-z.

    PMID: 27894277BACKGROUND
  • Karagiannidis E, Kellis E, Galanis N, Vasilios B. Semitendinosus muscle architecture during maximum isometric contractions in individuals with anterior cruciate ligament reconstruction and controls. Muscles Ligaments Tendons J. 2017 May 10;7(1):147-151. doi: 10.11138/mltj/2017.7.1.147. eCollection 2017 Jan-Mar.

    PMID: 28717622BACKGROUND
  • Peeler J, Anderson JE. Reliability of the Ely's test for assessing rectus femoris muscle flexibility and joint range of motion. J Orthop Res. 2008 Jun;26(6):793-9. doi: 10.1002/jor.20556.

    PMID: 18186129BACKGROUND
  • Bennell KL, Talbot RC, Wajswelner H, Techovanich W, Kelly DH, Hall AJ. Intra-rater and inter-rater reliability of a weight-bearing lunge measure of ankle dorsiflexion. Aust J Physiother. 1998;44(3):175-180. doi: 10.1016/s0004-9514(14)60377-9.

    PMID: 11676731BACKGROUND

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Central Study Contacts

Tüzün FIRAT, Associate professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: ESWT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc. physiotherapist

Study Record Dates

First Submitted

May 11, 2020

First Posted

June 1, 2020

Study Start

May 11, 2020

Primary Completion

July 5, 2020

Study Completion

September 1, 2021

Last Updated

February 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations