TendinopathyNCT04410705
Effect of Eswt on Muscle Architecture
A study testing Extracorporeal shockwave theraphy for hamstring tendinopathy, Extracorporeal shockwave theraphy for quadriceps tendinopathy and Extracorporeal shockwave theraphy for achilles tendinopathy in people with Tendinopathy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 52 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Extracorporeal shockwave theraphy for hamstring tendinopathy, Extracorporeal shockwave theraphy for quadriceps tendinopathy and Extracorporeal shockwave theraphy for achilles tendinopathy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 May 2020to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 52 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziantep Private Hatem Hospital
Gaziantep, 27000
aydan niziplioğlu, MSc, 05324132734, fzt.niziplioglu@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Tendinopathy
- Being tested
- Extracorporeal shockwave theraphy for hamstring tendinopathy, Extracorporeal shockwave theraphy for quadriceps tendinopathy, Extracorporeal shockwave theraphy for achilles tendinopathy
- Keywords
- Extracorporeal shockwave theraphy, Ultrasonography, muscle strength
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shockwave theraphy for hamstring tendinopathyOther
For hamstring tendinopathy; a total of 2000 impulses will be done. We will apply twice a week and 5 times in total.
Extracorporeal shockwave theraphy for quadriceps tendinopathyOther
Energy flux density will be 0.58mJ/mm2 (2 bar) with 2000 impulses. We will perform twice a week, 5 times in total.
Extracorporeal shockwave theraphy for achilles tendinopathyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tendinopathy patients | Experimental | Patients with tendinopathy will be administered ESWT Receives: Other: Extracorporeal shockwave theraphy for hamstring tendinopathy; Other: Extracorporeal shockwave theraphy for quadriceps tendinopathy; Other: Extracorporeal shockwave theraphy for achilles tendinopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
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
Measured: Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment.Change of flexibility in 3 weeks
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.
Measured: Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment..Change of flexibility in 3 weeks
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 .
Measured: Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment..Change of flexibility in 3 weeks
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.
Measured: Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment..Change of strength in 3 weeks
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
Measured: Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment. Change of strength in 3 weeks
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.
Measured: Measurements will perform prior to ESWT,immidiately after the first ESWT and last ESWT treatment.Change of strength in 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start11 May 2020
- Primary completion5 Jul 2020
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- ESWT
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aydan Niziplioğlu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410705
- Sponsor's protocol ID
- 2018-01
- Status last verified
- Feb 2021
- First submitted
- 11 May 2020
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22212274Shechtman 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.
PubMed 16059855English 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.
PubMed 22324054Strasser 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.
PubMed 23456136Valle 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.
PubMed 27896273Vetrano 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.
PubMed 21617986Kim 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.
PubMed 28332373Erroi 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.
PubMed 28717617Zwerver 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.
PubMed 20144188Askling 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.
PubMed 16371489Ozbek 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.
PubMed 31032341Arya 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.
PubMed 19892931Miyamoto 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.
PubMed 29190853Massey 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.
PubMed 26374174Turton 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.
PubMed 27894277
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation the Effect of the Extracorporeal Shock Wave Therapy on Muscle Strength, Flexibility and Architectural Features in Lower Extremity Tendinopathies
- ClinicalTrials.gov ID
- NCT04410705
- Acronym / sponsor ID
- 2018-01
- Conditions
- Tendinopathy
- Keywords
- Extracorporeal shockwave theraphy, Ultrasonography, muscle strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 5 Jul 2020 (actual)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ESWT
| Arm | Type | Receives |
|---|---|---|
| Tendinopathy patients | Experimental | Other: Extracorporeal shockwave theraphy for hamstring tendinopathy, Other: Extracorporeal shockwave theraphy for quadriceps tendinopathy, Other: Extracorporeal shockwave theraphy for achilles tendinopathyPatients with tendinopathy will be administered ESWT |
Who may qualify
- Ages
- 21 to 52 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shockwave theraphy for hamstring tendinopathyFor hamstring tendinopathy; a total of 2000 impulses will be done. We will apply twice a week and 5 times in total. | Other | Tendinopathy patients |
| Extracorporeal shockwave theraphy for quadriceps tendinopathyEnergy flux density will be 0.58mJ/mm2 (2 bar) with 2000 impulses. We will perform twice a week, 5 times in total. | Other | Tendinopathy patients |
| Extracorporeal shockwave theraphy for achilles tendinopathyEach 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. | Other | Tendinopathy patients |
Primary outcome
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
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
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Background: PubMed 22212274Atamaz 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.
- Background: PubMed 16059855Shechtman 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.
- Background: PubMed 22324054English 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.
- Background: PubMed 23456136Strasser 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.
- Background: PubMed 27896273Valle 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.
- Background: PubMed 21617986Vetrano 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.
- Background: PubMed 28332373Kim 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.
- Background: PubMed 28717617Erroi 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.
- Background: PubMed 20144188Zwerver 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.
- Background: PubMed 16371489Askling 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.
- Background: PubMed 31032341Ozbek 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.
- Background: PubMed 19892931Arya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shockwave theraphy for hamstring tendinopathy, Extracorporeal shockwave theraphy for quadriceps tendinopathy and Extracorporeal shockwave theraphy for achilles tendinopathy in people with Tendinopathy, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tüzün FIRAT, Associate professor (+90 532 671 06 35, tuzun75@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04410705, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.