ACL ReconstructionNCT06688344
Efficacy of Focused Extracorporeal Shock Wave Therapy After Anterior Cruciate Ligament Reconstruction
A study testing fESWT and Conventional Physiotherapy in people with ACL Reconstruction and Extracorpereal Shock Wave Therapy, run by Berivan Beril Kılıç at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial is to determine the effectiveness of fESWT in rehabilitation after ACL reconstruction. The main questions it aims to answer are: Is fESWT applied in addition to conventional physiotherapy effective in physiotherapy-related parameters? Researchers will compare conventional physiotherapy… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- ACL Reconstruction, Extracorpereal Shock Wave Therapy
- What is being tested?
- fESWT and Conventional Physiotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 45 years
- Unilateral ACL rupture
- Isolated ACL injury
- Hamstring graft
Who cannot join
- Previous knee injury and anterior cruciate ligament revision
- Synovitis, stiffness, tension
- History of systemic diseases such as rheumatoid arthritis, osteoarthritis, osteoporosis
- Presence of tumor
- Deep vein thrombosis or vascular pathology in the lower extremity
- RA or accompanying comorbidities
- Having had intra-articular injection within 6 months
- Cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Faculy of Medicine-Department of Sports Medicine
Istanbul
Berivan Beril Kılıç, asst. prof, +905069496158, berilk@biruni.edu.tr
About this study
Official title: Effectiveness of Focused Extracorporeal Shock Wave Therapy Applied as an Addition to Conventional Physiotherapy Program After Anterior Cruciate Ligament Reconstruction
The aim of this clinical trial is to determine the effectiveness of fESWT in rehabilitation after ACL reconstruction. The main questions it aims to answer are:
Is fESWT applied in addition to conventional physiotherapy effective in physiotherapy-related parameters?
Read more
Researchers will compare conventional physiotherapy and conventional physiotherapy + fESWT to see if fESWT provides benefits in addition to conventional physiotherapy.
Participants:
They will receive the conventional physiotherapy program 2 days per week. In addition, the intervention group will receive low-intensity fESWT 1 day per week.
Participants' muscle strength, postural balance, range of motion, pain scores and functional status will be assessed.
Read the detailed description
Extracorporeal shock wave therapy (ESWT) is a safe, effective and non-invasive treatment option that can be used in different pathologies of the musculoskeletal system. It is based on the production of acoustic waves that interact directly with cells through mechanotransduction and activate the metabolic process that leads to tissue remodeling. ESWT can be classified as focused ESWT (fESWT) and radial ESWT (rESWT). While rESWT has a more superficial effect and reaches the maximum energy at the skin surface and distributes it radially to the tissue, fESWT develops the maximum energy at a focus located deeper in the body tissues. Studies have suggested that ESWT can be applied in combination with physiotherapy in patients affected by musculoskeletal disorders . In the literature, its effectiveness has been investigated in different musculoskeletal problems such as lateral epicondylitis, rotator cuff tendinopathy, Achilles tendinopathy, patellar tendinopathy, greater trochanteric pain syndrome, plantar fasciitis, and the best evidence supporting the use of ESWT has been obtained with low to medium energy levels for tendon disorders and high energy levels for tendon calcification and bone pathologies . The usability of ESWT treatment in knee-related pathologies has been discussed in the literature. In the treatment of ligament injuries such as the medial collateral ligament, fESWT has been shown to be a reliable and safe light energy shock wave treatment for the management of injuries without surgical indications . It has been reported that it is useful for inducing neovascularization in knee tendon injuries, improving blood flow in the bone-tendon junction, and supporting tissue repair. It has been thought that it has chondroprotective, anti-inflammatory, neovascularization, antiapoptotic and tissue regeneration effects on tissues, and therefore can be used in osteoarthritis. Another situation where the effect of ESWT on knee pathologies has been investigated is anterior cruciate ligament (ACL) surgeries. ACL reconstruction surgery aims to restore knee functions by providing the tightest possible repair so that the reconstruction of the torn ligament can be an excellent biological replacement. The functional outcome of this surgery depends on the solid healing of the graft-bone union in the bone tunnel. It is known that if the bone and tendon do not heal together, this may lead to knee pathology in the future. Although the studies on the use of ESWT after ACL surgery are quite limited, more focus has been placed on the effect of ESWT on the graft. Wang et al. applied 1 session of fESWT in operating room conditions during anterior cruciate ligament reconstruction surgery and reported that the patients had higher functional levels compared to the control group at 1 and 2 years. Song et al. included 72 patients who underwent anterior cruciate ligament reconstruction and applied ESWT once a week starting from the 2nd postoperative day in addition to the standard physiotherapy protocol for 6 weeks. Significant improvements in 6-week functionality and range of motion values compared to the control group, and no significant difference was found between the groups at the end of 6 months. Moi et al. compared graft healing and knee functional results in groups that received only physiotherapy, physiotherapy + ESWT once a week between weeks 6-8, and ESWT once a week between weeks 7-12. As a result, they reported that 6-session application had positive effects on graft healing; and there was no difference between knee functional scores at the end of 6 months . In another study, Weninger et al. applied ESWT at 1 and 6 weeks and evaluated the patients at 3, 6, 9 and 12 months. They reported that there were greater improvements in knee functionality, daily living and pain scores at all times in the ESWT group compared to the control group in the evaluation parameters. In addition, they reported that graft maturation was better in the ESWT group . Rehabilitation protocols commonly used after surgery aim to restore mobility and regain independence in daily living activities through muscle strengthening, functional exercises and proprioception training. When the studies conducted after anterior cruciate ligament surgery in the literature are examined, the effects of ESWT on outcomes such as muscle strength, proprioception and postural stability, which are targeted to be increased with rehabilitation protocols, have not been examined. No studies have been found in the literature examining the effects of ESWT on muscle strength, range of motion and postural stability, which are affected after surgery and targeted to be improved in the rehabilitation program, other than the effect of ESWT on graft healing after ACL reconstruction surgery. In this context, the aim of this study is to investigate the effects of fESWT applied in addition to the traditional rehabilitation protocol after anterior cruciate ligament surgery on muscle strength, range of motion, postural stability, pain and functionality.
- Being tested
- fESWT, Conventional Physiotherapy, shamfESWT
- Keywords
- Physiotherapy and rehabilitation, ESWT, ACL reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fESWTOther
fESWT will be applied for 1 session between weeks 4-9. The device will be set to low intensity at 0.20 mJ/mm2 - 4 Hz, 500 pulses will be applied from the tibiofemoral interval to the center of the tibiofemoral joint, and 1000 pulses will be applied to the soft tissues around the patella.
Conventional PhysiotherapyOther
Also called Rehabilitation
Participants will be included in the traditional physiotherapy program for the first 9 weeks, and exercise progression will be provided in the form of weekly checks in the 10-12 week period. Between the 12-24th weeks, the exercise program will continue with face-to-face follow-up twice a month.
The traditional physiotherapy program to be applied in the first 9-week period will be as follows :
Week 1 Weight Transfer as Tolerable, NMES, Elevation, Cold Application, Ankle Pumping Exercises, Heel Slide Exercises, Isometric Quadriceps Exercises, Straight Leg Raise Exercises, Extension Brace
Week 2-3 Weight Transfer, Gait Training, NMES, Heel Slide Exercises, Straight Leg Raise, Quadriceps and Adductor Isometric Exercises, Extension Brace, Bicycle, Hip Abduction-Adduction Exercises
Week 4-8. week Mini Squat, Leg Press, Soft Ground Walking, Neuromuscular Training on Balance Board, Functional Strengthening with Elastic Band, Stair Climbing Up and Down
shamfESWTOther
Participants in the control group will receive sham fESWT once a week in weeks 4-9. Participants will be prepared in the same way as the fESWT procedure, but the application will be done with a sham device.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | fESWT Receives: Other: fESWT; Other: Conventional Physiotherapy |
| Control group | Sham comparator | Not described Receives: Other: Conventional Physiotherapy; Other: shamfESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee extansor muscle strength
The strength of the participants' knee flexor and knee extensor muscles will be measured with a hand held dynamometer.
Knee extensor muscle strength will be performed in a sitting position. Participants will be seated on an examination table with their knees bent at 60° and their feet off the ground. The dynamometer will be placed on the front of the distal tibia, just above the malleoli for extensor strength and the posterior aspect of the distal tibia, just above the malleoli for flexor strength . Participants will grip the examination table with their hands for stabilization and will be asked to apply force to the dynamometer for 5 seconds with maximum force. 3 repetitions will be performed and the average will be calculated by dividing by body weight in N/kg.
Measured: a time frame of 6,9,12 weeks
postural stability
Participants' single-leg and double-leg postural stability assessments will be performed with the Biodex brand balance system. General balance index (OSI), anteroposterior balance index (APSI) and mediolateral balance index (MLSI) will be recorded. Measurements will be performed without shoes, with eyes open and arms crossed over the body. While the level of the system drops from 12 to 10 in the double-leg assessment, it will drop from 12 to 10 in the single-leg assessment. Participants will proceed to the test protocol consisting of 3 2o seconds each after a single trial measurement. The average score from the three test assessments will be calculated and recorded. 5-minute rest breaks will be given between the tests.
Measured: a time frame of 6,9,12 weeks
Secondary outcomes (6)
range of motion
Knee extension and flexion joint range of motion will be performed in the prone position with the help of a goniometer. Measurements will be repeated 3 times and the average will be recorded.
Measured: a time frame of 6,9,12 weeks
pain assessment - VAS
The degree of pain of the participants will be assessed with a visual analog scale. Participants will be asked to give a value between 0-100 for the pain they feel in their knees and this score will be recorded. '0' means no pain is felt, while 100 means maximum pain is felt.
Measured: a time frame of 6,9,12 weeks
pain assessment-algometer
Another method to be used in pain assessment is to evaluate the pain pressure threshold of the participants with an algometer. In the assessment to be made with an algometer, the previous research was taken as a reference for the reference measurement points. Accordingly, the reference points are - 10 cm lateral to the middle point of the upper edge of the patella, - 3 cm medial to the upper middle point of the patella, - the middle point between the lower edge of the patella and the tibial tuberosity, - 3 cm proximal to the upper edge of the patella - 3 cm medial to the tuberosity of the tibia at the pes anserinus insertion. Three 10-second assessments will be performed with a 30-second rest at each point and the average (Kg) value will be recorded for analysis.
Measured: a time frame of 6,9,12 weeks
Functionality and daily living activity assessment-IKDC
IKDC (International Knee Documentation Committee): The IKDC Subjective Knee Form is designed to measure symptoms of various knee disorders such as ligament, meniscus and cartilage injuries and patellofemoral pain, and limitations in function and sports activities. It consists of 18 questions and 3 subscales. There are 7 questions for symptoms, 10 questions for sports activities and 1 question for function assessment. The total score range on the form varies between 0-100, with higher scores indicating fewer symptoms and a higher functional level. Its cultural adaptation was made by Çelik et al.
Measured: a time frame of 6,9,12 weeks
Functionality and daily living activity assessment-Lysholm Scale
The scale, consisting of 8 questions, was designed to evaluate the results of knee ligament surgery, especially instability symptoms, in patients with anteromedial, anterolateral, combined anteromedial/anterolateral, posterolateral rotator knee ligament injuries or straight posterior instability. Scoring is done out of 100. Scores between 95-100 are considered excellent, 84-94 good results, 65-83 moderate and values below 65 poor results. The scale has been validated in Turkish.
Measured: a time frame of 6,9,12 weeks
Kinesiophobia assessment
A scale consisting of 17 questions developed to assess the fear of pain associated with movement in patients with musculoskeletal pain. It includes occupational injury, re-injury and fearful avoidance parameters. The validity and reliability of the questionnaire in Turkish has been performed. The scale can be scored between 17 and 68. As the score on the scale increases, the level of kinesiophobia increases.
Measured: a time frame of 6,9,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Dec 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for ACL ReconstructionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berivan Beril Kılıç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Berivan Beril Kılıç, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688344
- Sponsor's protocol ID
- 2982164
- Status last verified
- Dec 2025
- First submitted
- 11 Nov 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tampa Kinezyofobi Ölçeği'nin Türkçe versiyonu ve test-tekrar test güvenirliği.
Hapidou EG, O'Brien MA, Pierrynowski MR, de Las Heras E, Patel M, Patla T. Fear and Avoidance of Movement in People with Chronic Pain: Psychometric Properties of the 11-Item Tampa Scale for Kinesiophobia (TSK-11). Physiother Can. 2012 Summer;64(3):235-41. doi: 10.3138/ptc.2011-10.
PubMed 23729957Celik D, Coskunsu D, Kilicoglu O. Translation and cultural adaptation of the Turkish Lysholm knee scale: ease of use, validity, and reliability. Clin Orthop Relat Res. 2013 Aug;471(8):2602-10. doi: 10.1007/s11999-013-3046-z. Epub 2013 May 11.
PubMed 23666590Lysholm J, Gillquist J. Evaluation of knee ligament surgery results with special emphasis on use of a scoring scale. Am J Sports Med. 1982 May-Jun;10(3):150-4. doi: 10.1177/036354658201000306.
PubMed 6896798Celik D, Coskunsu D, KiliCoglu O, Ergonul O, Irrgang JJ. Translation and cross-cultural adaptation of the international knee documentation committee subjective knee form into Turkish. J Orthop Sports Phys Ther. 2014 Nov;44(11):899-909. doi: 10.2519/jospt.2014.4865. Epub 2014 Oct 16.
PubMed 25323139Medial patellofemoral ligament rekonstrüksiyonu sonrası kalça abduktör kas kuvvetlendirme egzersizlerinin diz fonksiyonu üzerine etkisi.
Irrgang JJ, Anderson AF, Boland AL, Harner CD, Kurosaka M, Neyret P, Richmond JC, Shelborne KD. Development and validation of the international knee documentation committee subjective knee form. Am J Sports Med. 2001 Sep-Oct;29(5):600-13. doi: 10.1177/03635465010290051301.
PubMed 11573919Akbari A, Ghiasi F, Mir M, Hosseinifar M. The Effects of Balance Training on Static and Dynamic Postural Stability Indices After Acute ACL Reconstruction. Glob J Health Sci. 2015 Jul 31;8(4):68-81. doi: 10.5539/gjhs.v8n4p68.
PubMed 26573034Martin-Alguacil JL, Arroyo-Morales M, Martin-Gomez JL, Lozano-Lozano M, Galiano-Castillo N, Cantarero-Villanueva I. Comparison of knee sonography and pressure pain threshold after anterior cruciate ligament reconstruction with quadriceps tendon versus hamstring tendon autografts in soccer players. Acta Orthop Traumatol Turc. 2019 Jul;53(4):260-265. doi: 10.1016/j.aott.2019.04.012. Epub 2019 Jun 12.
PubMed 31201076Luc-Harkey BA, Safran-Norton CE, Mandl LA, Katz JN, Losina E. Associations among knee muscle strength, structural damage, and pain and mobility in individuals with osteoarthritis and symptomatic meniscal tear. BMC Musculoskelet Disord. 2018 Jul 27;19(1):258. doi: 10.1186/s12891-018-2182-8.
PubMed 30049269Sık Yapılan Ortopedik Ameliyatlar ve Rehabilitasyon Yaklaşımları. İstanbul Tıp Kitabevleri
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Rahim M, Ooi FK, Shihabudin MT, Chen CK, Musa AT. The Effects of Three and Six Sessions of Low Energy Extracorporeal Shockwave Therapy on Graft Incorporation and Knee Functions Post Anterior Cruciate Ligament Reconstruction. Malays Orthop J. 2022 Mar;16(1):28-39. doi: 10.5704/MOJ.2203.005.
PubMed 35519531Song Y, Che X, Wang Z, Li M, Zhang R, Wang D, Shi Q. A randomized trial of treatment for anterior cruciate ligament reconstruction by radial extracorporeal shock wave therapy. BMC Musculoskelet Disord. 2024 Jan 13;25(1):57. doi: 10.1186/s12891-024-07177-8.
PubMed 38216944Wang CJ, Ko JY, Chou WY, Hsu SL, Ko SF, Huang CC, Chang HW. Shockwave therapy improves anterior cruciate ligament reconstruction. J Surg Res. 2014 May 1;188(1):110-8. doi: 10.1016/j.jss.2014.01.050. Epub 2014 Jan 31.
PubMed 24560350
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Focused Extracorporeal Shock Wave Therapy Applied as an Addition to Conventional Physiotherapy Program After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06688344
- Acronym / sponsor ID
- 2982164
- Keywords
- Physiotherapy and rehabilitation, ESWT, ACL reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Berivan Beril KılıçUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 14 Nov 2024 (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 this clinical trial is to determine the effectiveness of fESWT in rehabilitation after ACL reconstruction. The main questions it aims to answer are:
Is fESWT applied in addition to conventional physiotherapy effective in physiotherapy-related parameters?
Researchers will compare conventional physiotherapy and conventional physiotherapy + fESWT to see if fESWT provides benefits in addition to conventional physiotherapy.
Participants:
They will receive the conventional physiotherapy program 2 days per week. In addition, the intervention group will receive low-intensity fESWT 1 day per week.
Participants' muscle strength, postural balance, range of motion, pain scores and functional status will be assessed.
Detailed description
Extracorporeal shock wave therapy (ESWT) is a safe, effective and non-invasive treatment option that can be used in different pathologies of the musculoskeletal system. It is based on the production of acoustic waves that interact directly with cells through mechanotransduction and activate the metabolic process that leads to tissue remodeling. ESWT can be classified as focused ESWT (fESWT) and radial ESWT (rESWT). While rESWT has a more superficial effect and reaches the maximum energy at the skin surface and distributes it radially to the tissue, fESWT develops the maximum energy at a focus located deeper in the body tissues. Studies have suggested that ESWT can be applied in combination with physiotherapy in patients affected by musculoskeletal disorders . In the literature, its effectiveness has been investigated in different musculoskeletal problems such as lateral epicondylitis, rotator cuff tendinopathy, Achilles tendinopathy, patellar tendinopathy, greater trochanteric pain syndrome, plantar fasciitis, and the best evidence supporting the use of ESWT has been obtained with low to medium energy levels for tendon disorders and high energy levels for tendon calcification and bone pathologies . The usability of ESWT treatment in knee-related pathologies has been discussed in the literature. In the treatment of ligament injuries such as the medial collateral ligament, fESWT has been shown to be a reliable and safe light energy shock wave treatment for the management of injuries without surgical indications . It has been reported that it is useful for inducing neovascularization in knee tendon injuries, improving blood flow in the bone-tendon junction, and supporting tissue repair. It has been thought that it has chondroprotective, anti-inflammatory, neovascularization, antiapoptotic and tissue regeneration effects on tissues, and therefore can be used in osteoarthritis. Another situation where the effect of ESWT on knee pathologies has been investigated is anterior cruciate ligament (ACL) surgeries. ACL reconstruction surgery aims to restore knee functions by providing the tightest possible repair so that the reconstruction of the torn ligament can be an excellent biological replacement. The functional outcome of this surgery depends on the solid healing of the graft-bone union in the bone tunnel. It is known that if the bone and tendon do not heal together, this may lead to knee pathology in the future. Although the studies on the use of ESWT after ACL surgery are quite limited, more focus has been placed on the effect of ESWT on the graft. Wang et al. applied 1 session of fESWT in operating room conditions during anterior cruciate ligament reconstruction surgery and reported that the patients had higher functional levels compared to the control group at 1 and 2 years. Song et al. included 72 patients who underwent anterior cruciate ligament reconstruction and applied ESWT once a week starting from the 2nd postoperative day in addition to the standard physiotherapy protocol for 6 weeks. Significant improvements in 6-week functionality and range of motion values compared to the control group, and no significant difference was found between the groups at the end of 6 months. Moi et al. compared graft healing and knee functional results in groups that received only physiotherapy, physiotherapy + ESWT once a week between weeks 6-8, and ESWT once a week between weeks 7-12. As a result, they reported that 6-session application had positive effects on graft healing; and there was no difference between knee functional scores at the end of 6 months . In another study, Weninger et al. applied ESWT at 1 and 6 weeks and evaluated the patients at 3, 6, 9 and 12 months. They reported that there were greater improvements in knee functionality, daily living and pain scores at all times in the ESWT group compared to the control group in the evaluation parameters. In addition, they reported that graft maturation was better in the ESWT group . Rehabilitation protocols commonly used after surgery aim to restore mobility and regain independence in daily living activities through muscle strengthening, functional exercises and proprioception training. When the studies conducted after anterior cruciate ligament surgery in the literature are examined, the effects of ESWT on outcomes such as muscle strength, proprioception and postural stability, which are targeted to be increased with rehabilitation protocols, have not been examined. No studies have been found in the literature examining the effects of ESWT on muscle strength, range of motion and postural stability, which are affected after surgery and targeted to be improved in the rehabilitation program, other than the effect of ESWT on graft healing after ACL reconstruction surgery. In this context, the aim of this study is to investigate the effects of fESWT applied in addition to the traditional rehabilitation protocol after anterior cruciate ligament surgery on muscle strength, range of motion, postural stability, pain and functionality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: fESWT, Other: Conventional PhysiotherapyfESWT |
| Control group | Sham comparator | Other: Conventional Physiotherapy, Other: shamfESWT |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 45 years
- Unilateral ACL rupture
- Isolated ACL injury
- Hamstring graft
Key exclusion criteria (8 listed)
- Previous knee injury and anterior cruciate ligament revision
- Synovitis, stiffness, tension
- History of systemic diseases such as rheumatoid arthritis, osteoarthritis, osteoporosis
- Presence of tumor
- Deep vein thrombosis or vascular pathology in the lower extremity
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 |
|---|---|---|
| fESWTfESWT will be applied for 1 session between weeks 4-9. The device will be set to low intensity at 0.20 mJ/mm2 - 4 Hz, 500 pulses will be applied from the tibiofemoral interval to the center of the tibiofemoral joint, and 1000 pulses will be applied to the soft tissues around the patella. | Other | Intervention group |
| Conventional PhysiotherapyAlso: RehabilitationParticipants will be included in the traditional physiotherapy program for the first 9 weeks, and exercise progression will be provided in the form of weekly checks in the 10-12 week period. Between the 12-24th weeks, the exercise program will continue with face-to-face follow-up twice a month. The traditional physiotherapy program to be applied in the first 9-week period will be as follows : Week 1 Weight Transfer as Tolerable, NMES, Elevation, Cold Application, Ankle Pumping Exercises, Heel Slide Exercises, Isometric Quadriceps Exercises, Straight Leg Raise Exercises, Extension Brace Week 2-3 Weight Transfer, Gait Training, NMES, Heel Slide Exercises, Straight Leg Raise, Quadriceps and Adductor Isometric Exercises, Extension Brace, Bicycle, Hip Abduction-Adduction Exercises Week 4-8. week Mini Squat, Leg Press, Soft Ground Walking, Neuromuscular Training on Balance Board, Functional Strengthening with Elastic Band, Stair Climbing Up and Down | Other | Control group, Intervention group |
| shamfESWTParticipants in the control group will receive sham fESWT once a week in weeks 4-9. Participants will be prepared in the same way as the fESWT procedure, but the application will be done with a sham device. | Other | Control group |
Primary outcome
Knee extansor muscle strength
Time frame: a time frame of 6,9,12 weeks
The strength of the participants' knee flexor and knee extensor muscles will be measured with a hand held dynamometer. Knee extensor muscle strength will be performed in a sitting position. Participants will be seated on an examination table with their knees bent at 60° and their feet off the ground. The dynamometer will be placed on the front of the distal tibia, just above the malleoli for extensor strength and the posterior aspect of the distal tibia, just above the malleoli for flexor strength . Participants will grip the examination table with their hands for stabilization and will be asked to apply force to the dynamometer for 5 seconds with maximum force. 3 repetitions will be performed and the average will be calculated by dividing by body weight in N/kg.
postural stability
Time frame: a time frame of 6,9,12 weeks
Participants' single-leg and double-leg postural stability assessments will be performed with the Biodex brand balance system. General balance index (OSI), anteroposterior balance index (APSI) and mediolateral balance index (MLSI) will be recorded. Measurements will be performed without shoes, with eyes open and arms crossed over the body. While the level of the system drops from 12 to 10 in the double-leg assessment, it will drop from 12 to 10 in the single-leg assessment. Participants will proceed to the test protocol consisting of 3 2o seconds each after a single trial measurement. The average score from the three test assessments will be calculated and recorded. 5-minute rest breaks will be given between the tests.
6 secondary outcomes
range of motion
Time frame: a time frame of 6,9,12 weeks
pain assessment - VAS
Time frame: a time frame of 6,9,12 weeks
pain assessment-algometer
Time frame: a time frame of 6,9,12 weeks
Functionality and daily living activity assessment-IKDC
Time frame: a time frame of 6,9,12 weeks
Functionality and daily living activity assessment-Lysholm Scale
Time frame: a time frame of 6,9,12 weeks
Kinesiophobia assessment
Time frame: a time frame of 6,9,12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publicationTampa Kinezyofobi Ölçeği'nin Türkçe versiyonu ve test-tekrar test güvenirliği.
- Results publication: PubMed 23729957Hapidou EG, O'Brien MA, Pierrynowski MR, de Las Heras E, Patel M, Patla T. Fear and Avoidance of Movement in People with Chronic Pain: Psychometric Properties of the 11-Item Tampa Scale for Kinesiophobia (TSK-11). Physiother Can. 2012 Summer;64(3):235-41. doi: 10.3138/ptc.2011-10.
- Results publication: PubMed 23666590Celik D, Coskunsu D, Kilicoglu O. Translation and cultural adaptation of the Turkish Lysholm knee scale: ease of use, validity, and reliability. Clin Orthop Relat Res. 2013 Aug;471(8):2602-10. doi: 10.1007/s11999-013-3046-z. Epub 2013 May 11.
- Results publication: PubMed 6896798Lysholm J, Gillquist J. Evaluation of knee ligament surgery results with special emphasis on use of a scoring scale. Am J Sports Med. 1982 May-Jun;10(3):150-4. doi: 10.1177/036354658201000306.
- Results publication: PubMed 25323139Celik D, Coskunsu D, KiliCoglu O, Ergonul O, Irrgang JJ. Translation and cross-cultural adaptation of the international knee documentation committee subjective knee form into Turkish. J Orthop Sports Phys Ther. 2014 Nov;44(11):899-909. doi: 10.2519/jospt.2014.4865. Epub 2014 Oct 16.
- Results publicationMedial patellofemoral ligament rekonstrüksiyonu sonrası kalça abduktör kas kuvvetlendirme egzersizlerinin diz fonksiyonu üzerine etkisi.
- Results publication: PubMed 11573919Irrgang JJ, Anderson AF, Boland AL, Harner CD, Kurosaka M, Neyret P, Richmond JC, Shelborne KD. Development and validation of the international knee documentation committee subjective knee form. Am J Sports Med. 2001 Sep-Oct;29(5):600-13. doi: 10.1177/03635465010290051301.
- Results publication: PubMed 26573034Akbari A, Ghiasi F, Mir M, Hosseinifar M. The Effects of Balance Training on Static and Dynamic Postural Stability Indices After Acute ACL Reconstruction. Glob J Health Sci. 2015 Jul 31;8(4):68-81. doi: 10.5539/gjhs.v8n4p68.
- Results publication: PubMed 31201076Martin-Alguacil JL, Arroyo-Morales M, Martin-Gomez JL, Lozano-Lozano M, Galiano-Castillo N, Cantarero-Villanueva I. Comparison of knee sonography and pressure pain threshold after anterior cruciate ligament reconstruction with quadriceps tendon versus hamstring tendon autografts in soccer players. Acta Orthop Traumatol Turc. 2019 Jul;53(4):260-265. doi: 10.1016/j.aott.2019.04.012. Epub 2019 Jun 12.
- Results publication: PubMed 30049269Luc-Harkey BA, Safran-Norton CE, Mandl LA, Katz JN, Losina E. Associations among knee muscle strength, structural damage, and pain and mobility in individuals with osteoarthritis and symptomatic meniscal tear. BMC Musculoskelet Disord. 2018 Jul 27;19(1):258. doi: 10.1186/s12891-018-2182-8.
- Results publicationSık Yapılan Ortopedik Ameliyatlar ve Rehabilitasyon Yaklaşımları. İstanbul Tıp Kitabevleri
- Results publication: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Individual participant dataSharing planned: Undecided
Related trials for ACL Reconstruction
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Interventions to Enhance Quadriceps Output After ACLR
ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fESWT and Conventional Physiotherapy in people with ACL Reconstruction and Extracorpereal Shock Wave Therapy, run by Berivan Beril Kılıç 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 19 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Berivan Beril Kılıç, Asst. Prof. (+905069496158, berilk@biruni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee extansor muscle strength (time frame: a time frame of 6,9,12 weeks). The study lists 2 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 NCT06688344, which also lists 27 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 19 Dec 2025.