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Efficacy of Focused Extracorporeal Shock Wave Therapy After Anterior Cruciate Ligament Reconstruction

NCT ID: NCT06688344

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2027-05-01

Brief Summary

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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

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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.

Conditions

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ACL Reconstruction Extracorpereal Shock Wave Therapy

Keywords

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Physiotherapy and rehabilitation ESWT ACL reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention group

fESWT

Group Type ACTIVE_COMPARATOR

fESWT

Intervention Type OTHER

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 Physiotherapy

Intervention Type OTHER

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

Control group

Group Type SHAM_COMPARATOR

Conventional Physiotherapy

Intervention Type OTHER

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

shamfESWT

Intervention Type OTHER

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.

Interventions

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fESWT

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.

Intervention Type OTHER

Conventional Physiotherapy

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

Intervention Type OTHER

shamfESWT

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.

Intervention Type OTHER

Other Intervention Names

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Rehabilitation

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 45 years
* Unilateral ACL rupture
* Isolated ACL injury
* Hamstring graft

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Berivan Beril Kılıç

OTHER

Sponsor Role lead

Responsible Party

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Berivan Beril Kılıç

assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Istanbul Faculy of Medicine-Department of Sports Medicine

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Berivan Beril Kılıç, Asst. Prof.

Role: CONTACT

Phone: +905069496158

Email: [email protected]

Facility Contacts

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Berivan Beril Kılıç, asst. prof

Role: primary

References

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Moya D, Ramon S, Schaden W, Wang CJ, Guiloff L, Cheng JH. The Role of Extracorporeal Shockwave Treatment in Musculoskeletal Disorders. J Bone Joint Surg Am. 2018 Feb 7;100(3):251-263. doi: 10.2106/JBJS.17.00661. No abstract available.

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Demange MK, de Almeida AM, Rodeo SA. Updates in biological therapies for knee injuries: tendons. Curr Rev Musculoskelet Med. 2014 Sep;7(3):239-46. doi: 10.1007/s12178-014-9230-2.

Reference Type RESULT
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Treatment of medial collateral ligament injuries of the knee with focused extracorporeal shockwave therapy: A case report.

Reference Type RESULT

Shultz SJ, Sander TC, Kirk SE, Perrin DH. Sex differences in knee joint laxity change across the female menstrual cycle. J Sports Med Phys Fitness. 2005 Dec;45(4):594-603.

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Medial patellofemoral ligament rekonstrüksiyonu sonrası kalça abduktör kas kuvvetlendirme egzersizlerinin diz fonksiyonu üzerine etkisi.

Reference Type RESULT

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.

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Reference Type RESULT
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Martin-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.

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Luc-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.

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Other Identifiers

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2982164

Identifier Type: -

Identifier Source: org_study_id