Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
ID06688344

Effectiveness of Focused Extracorporeal Shock Wave Therapy Added to Conventional Physiotherapy After Anterior Cruciate Ligament Reconstruction

Led by Berivan Beril Kılıç · Updated on 2025-12-19

32

Participants Needed

1

Research Sites

21 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of focused extracorporeal shock wave therapy (fESWT) in rehabilitation after anterior cruciate ligament (ACL) reconstruction. This trial aims to determine whether adding fESWT to conventional physiotherapy improves muscle strength, postural balance, range of motion, pain, and functional status compared to physiotherapy alone. The study focuses on patients with isolated unilateral ACL ruptures who have undergone hamstring graft surgery. Participants will be randomly assigned to two groups. One group will receive conventional physiotherapy twice a week for 9 weeks, followed by exercise progression and face-to-face follow-up over the next several weeks. The intervention group will also receive one session per week of low-intensity fESWT between weeks 4 and 9, targeting specific knee areas. The control group will receive sham fESWT with a non-active device during the same period. During the study, researchers will assess outcomes including knee extensor muscle strength and postural stability at 6, 9, and 12 weeks. Secondary measures include range of motion, pain levels, functional ability, and fear of movement, all evaluated at the same time points. This trial uses double-blind masking and will monitor participants closely throughout the treatment and follow-up periods, with a total study duration extending to 12 weeks for primary assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 45 years
  • Unilateral ACL rupture
  • Isolated ACL injury
  • Hamstring graft
Not Eligible

You will not qualify if you...

  • 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
  • Rheumatoid arthritis or accompanying comorbidities
  • Having had intra-articular injection within 6 months
  • Cognitive impairment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 24 weeks

Participants undergo conventional physiotherapy for the first 9 weeks after ACL reconstruction surgery. Between weeks 4 and 9, participants receive either one session of focused extracorporeal shock wave therapy (fESWT) or sham fESWT in addition to physiotherapy. Exercise progression is checked weekly during weeks 10 to 12, followed by continued physiotherapy with face-to-face follow-ups twice a month between weeks 12 and 24.

Weekly visits during weeks 10 to 12; twice-monthly visits between weeks 12 and 24

Trial Site Locations

Total: 1 location

1

Istanbul Faculy of Medicine-Department of Sports Medicine

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

B

Berivan Beril Kılıç, Asst. Prof.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Fear and Avoidance of Movement in People with Chronic Pain: Psychometric Properties of the 11-Item Tampa Scale for Kinesiophobia (TSK-11).

Eleni G Hapidou, Mary Ann O'Brien, Michael Raymond Pierrynowski...

https://pubmed.ncbi.nlm.nih.gov/23729957

Translation and cross-cultural adaptation of the international knee documentation committee subjective knee form into Turkish.

Derya Çelik, Dilber Coşkunsu, Önder KiliÇoğlu...

https://pubmed.ncbi.nlm.nih.gov/25323139

Comparison of knee sonography and pressure pain threshold after anterior cruciate ligament reconstruction with quadriceps tendon versus hamstring tendon autografts in soccer players.

Jose L Martin-Alguacil, Manuel Arroyo-Morales, Jose Luis Martin-Gómez...

https://pubmed.ncbi.nlm.nih.gov/31201076

Associations among knee muscle strength, structural damage, and pain and mobility in individuals with osteoarthritis and symptomatic meniscal tear.

Brittney A Luc-Harkey, Clare E Safran-Norton, Lisa A Mandl...

https://pubmed.ncbi.nlm.nih.gov/30049269

The Effects of Three and Six Sessions of Low Energy Extracorporeal Shockwave Therapy on Graft Incorporation and Knee Functions Post Anterior Cruciate Ligament Reconstruction.

M Rahim, F K Ooi, M T Shihabudin...

https://pubmed.ncbi.nlm.nih.gov/35519531