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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBerivan Beril Kılıç

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 45 years

Unilateral ACL rupture

Isolated ACL injury

Hamstring graft

Disqualifiers

Previous knee injury and anterior cruciate ligament revision

Synovitis, stiffness, tension

History of systemic diseases such as rheumatoid arthritis, osteoarthritis, osteoporosis

Presence of tumor

Trial design

Design model

Parallel

Treatments tested in this trial

  • fESWT

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Intervention groupActive comparator 2 interventions
Group B: Control groupSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
a time frame of 6,9,12 weeks
2

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.

Time frame
a time frame of 6,9,12 weeks

Secondary outcomes

1

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.

Time frame
a time frame of 6,9,12 weeks
2

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.

Time frame
a time frame of 6,9,12 weeks
3

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.

Time frame
a time frame of 6,9,12 weeks
4

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.

Time frame
a time frame of 6,9,12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Berivan Beril Kılıç

Lead sponsor

Biruni University

Sponsor institution