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

NCT06688344 | Recruiting

• 1 other identifier: 2982164
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

ACL Reconstruction; Extracorpereal Shock Wave Therapy

Keywords

Physiotherapy and rehabilitation; ESWT; ACL reconstruction

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  a time frame of 6,9,12 weeks

Secondary Outcomes (6)

• range of motion

  a time frame of 6,9,12 weeks

• pain assessment - VAS

  a time frame of 6,9,12 weeks

• pain assessment-algometer

  a time frame of 6,9,12 weeks

• Functionality and daily living activity assessment-IKDC

  a time frame of 6,9,12 weeks

• Functionality and daily living activity assessment-Lysholm Scale

  a time frame of 6,9,12 weeks

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

fESWT

Other: fESWT; Other: Conventional Physiotherapy

Control group

SHAM COMPARATOR

Other: Conventional Physiotherapy; Other: shamfESWT

Interventions

fESWT 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.

Intervention group

Conventional Physiotherapy 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

Also known as: Rehabilitation

Control group; Intervention group

shamfESWT 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.

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Berivan Beril Kılıç: lead

Study Sites (1)

Istanbul Faculy of Medicine-Department of Sports Medicine

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (27)

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MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Berivan Beril Kılıç, Asst. Prof.

CONTACT

+905069496158; berilk@biruni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 14, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

TU (1)