- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06995794
- Original Trial
Osgood-Schlatter Disease in Athletic Children
Effect Of Kinesio Tape Versus Knee Strap on Osgood Schlatter Disease in Athletic Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Osgood-Schlatter disease is a traction apophysitis of the tibial tuberosity caused by the repetitive pull of the patellar tendon on the tibia. This condition was described separately and simultaneously by Robert Osgood and Carl Schlatter in 1903 as a lesion where the tibial tubercle separates due to repetitive strain by the patellar tendon and becomes tender. Kicking, jumping, sprinting sports, a history of previous Sever's disease, and lower limb muscle tightness are among the risk factors that have been associated with Osgood-Schlatter disease. It is one of the leading causes of anterior knee pain in children and adolescents. Usually, patient history and physical examination are sufficient for diagnosis. It can be easily recognized by local pain, swelling, and tenderness on the tuberosity in one or both knees.
Osgood-Schlatter disease (OSD) is a common pediatric disorder. It is a growth- and sports-associated knee injury with pain around the tibial tuberosity and morphological alterations around the apophysis during adolescent growth. It often results from acute or chronic overload during sports activity, causing inflammation of the patellar tendon insertion on the tibial tuberosity. It was first described in 1903 independently by Osgood in the US and by Schlatter in Switzerland. Classically, the clinical presentation is associated with an insidious onset (usually atraumatic) of anterior functional knee pain over the tibial tuberosity along with a bony prominence, as well as tenderness at the patellar tendon insertion site.
Osgood-Schlatter disease occurs during the apophyseal phase between the ages of 12 and 15 in boys and 8 and 12 in girls. During the maturation phase, the cartilage cells of the proximal part of the tuberosity migrate distally, replacing the fibrocartilage in the middle part. This makes the tuberosity unable to withstand the force exerted by the quadriceps, resulting in micro-avulsions, with secondary ossification. These bone fragments are secondarily incorporated into the remainder of the tibial tuberosity, which can result in sequelae of an enlarged tuberosity. In rare cases, the fragments are not incorporated, and intratendinous bone fragments can remain after growth stops, requiring surgical removal. The pain usually occurs during and after physical activity and might be associated with local swelling. Many patients are completely asymptomatic, with less than 25% reporting pain at the tibial tuberosity apophysis. The age of onset is between 8 and 15 years. Boys experience it more often than girls, with a male-to-female ratio of 3:1. The prevalence of OSD is 9.8%, and it can be bilateral in 20-30% of patients. Many risk factors and activities have been associated with an increased incidence of the pathology.
Treatment is generally conservative, with rest, ice, and specific exercises recommended. It involves limiting activity until inflammation resolves and performing exercises that strengthen the surrounding musculature to reduce stress across the tibial tuberosity. Treatment with the PRICE protocol (Protection, Rest, Ice, Compression, Elevation), physical therapy, and strict activity modification is initiated. Surgical removal of ossicles may be considered. A knee strap can immobilize and protect joints, reduce pain, decrease swelling, and facilitate healing of acute injuries. Knee straps are also used for injury prevention and chronic pain reduction. Infrapatellar strapping is a treatment technique employed for various knee pathologies; however, its effect on pain and functional performance among young athletes has not been studied.
Kinesio Taping is effective in improving pain and joint function in patients with knee osteoarthritis. Kinesiology tape is used in the treatment of muscle, fascia, and tendon symptoms and for performance enhancement by way of continuous receptor stimulation. The natural healing process is instantly enhanced due to improved circulation in the taped area. When a muscle is inflamed, swollen, or stiff, the space between the skin and the muscle is compressed, resulting in constriction and congestion of lymphatic fluid and blood circulation. This compression applies pressure to pain receptors located in the space between the skin and the muscle, relaying discomfort signals to the brain and causing the sensation of pain. Stretching the skin of the affected area before applying Kinesiology Tape ensures that the taped area will form wrinkles when the applied area returns to its neutral position. This wrinkling effect is essential because the lifting of the skin creates more space for lymph and blood flow. Consequently, lymph drainage and blood circulation in the affected area are improved effectively through taping application. The friction between the tissues beneath the skin decreases due to the promoted movement of lymphatic fluid and blood circulation. Pain is reduced as the pressure on the pain receptors lessens. The end result is believed to be reduced muscle fatigue, an increased range of motion, and improved quality of muscle contraction.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ahmed hosny eldersy
- Phone Number: +201159523871
- Email: ahmed.eldersy@gmail.com
Study Contact Backup
- Name: samar t elbanna
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Children will be included in the study if they fulfil the following criteria:
- A medical diagnosis with Osgood Schlatter disease was made by paediatricians or paediatric orthopaedist.
- Number of the participate children will be 38 children.
- Age ranges from 9 to 15 years.
Exclusion Criteria:
Children will be excluded from the study if:
- They had a permanent deformity (bony or soft tissue contractures).
- Children have visual or auditory defects.
- Children with intelligence quotient less than 70.
- Children who had undergone a previous surgical intervention to knee joint.
- A history of epileptic seizure and any diagnosed cardiac or orthopaedic disability that may prevent the use of assessment methods.
- Children who are absent in two sessions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: effect of Kinesio tape application in Osgood Schlatter disease
will recieve kinesio tape in addition to traditional exercises program including ultrasoud therapy and heat application.
|
Kinesio tape a therapeutic tape that's applied strategically to the body to provide lessen pain, reduce swelling, improve performance.
|
|
Active Comparator: effect of knee strap application in Osgood Schlatter disease
knee strap in addition to traditional exercises program including ultrasoud therapy and heat application.
|
knee strap is used to support the tibial tuberosity which lessen the pain and enhance performance of the knee
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of the effect of knee strap with the effect of Kinesio tape on pain management in Osgood Schlatter disease
Time Frame: baseline
|
Pain assessment using visual analogue scale.
it is widely used to assess pain using straight horizontal line with a fixed length usually 100mm, the two ends of the line represent the extreme limits of the parameter being measured, the left end represents the worst condition while the right end represent the best condition.
zero to ten from left to right, zero means no pain and ten is the worest pain
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion assessment
Time Frame: baseline
|
Range of motion using electrical goniometer.
Universal goniometer in clinical evaluations of patients (as they are easy to be employed) and electro goniometer in laboratory studies (as they are more accurate) are reliable to test the knee range of motion.
|
baseline
|
|
muscle power assessment
Time Frame: baseline
|
Muscle strength in the quadriceps may be weaker due to limited exercise, as pain persists.
The Lafayette Manual Muscle Tester is used to measure maximal isometric knee extension and flexion.
A higher value indicates greater muscle strength
|
baseline
|
|
functional assessment
Time Frame: baseline
|
Single leg triple hops Functional scale to evaluate the activity pre and post treatment for both groups
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: samar t elbanna, Kafr Elshekh university
Publications and helpful links
General Publications
- Lu Z, Li X, Chen R, Guo C. Kinesio taping improves pain and function in patients with knee osteoarthritis: A meta-analysis of randomized controlled trials. Int J Surg. 2018 Nov;59:27-35. doi: 10.1016/j.ijsu.2018.09.015. Epub 2018 Sep 28.
- Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
- Shamsi M, Mirzaei M, Khabiri SS. Universal goniometer and electro-goniometer intra-examiner reliability in measuring the knee range of motion during active knee extension test in patients with chronic low back pain with short hamstring muscle. BMC Sports Sci Med Rehabil. 2019 Mar 22;11:4. doi: 10.1186/s13102-019-0116-x. eCollection 2019.
- Logan CA, Bhashyam AR, Tisosky AJ, Haber DB, Jorgensen A, Roy A, Provencher MT. Systematic Review of the Effect of Taping Techniques on Patellofemoral Pain Syndrome. Sports Health. 2017 Sep/Oct;9(5):456-461. doi: 10.1177/1941738117710938. Epub 2017 Jun 15.
- Greenberg EM, Dyke J, Leung A, Karl M, Lawrence JT, Ganley T. Uninjured Youth Athlete Performance on Single-Leg Hop Testing: How Many Can Achieve Recommended Return-to-Sport Criterion? Sports Health. 2020 Nov/Dec;12(6):552-558. doi: 10.1177/1941738120911662. Epub 2020 May 11.
- Knapik JJ, Wright JE, Mawdsley RH, Braun JM. Isokinetic, isometric and isotonic strength relationships. Arch Phys Med Rehabil. 1983 Feb;64(2):77-80.
- Davis J, Doyle B, Ishii H, Jayanthi N. S.P.O.R.R.T.-A Comprehensive Approach to the Assessment and Non-Operative Management of Overuse Knee Conditions in Youth Athletes. Curr Rev Musculoskelet Med. 2023 Dec;16(12):627-638. doi: 10.1007/s12178-023-09874-8. Epub 2023 Nov 24.
- van Leeuwen GJ, de Schepper EI, Rathleff MS, Bindels PJ, Bierma-Zeinstra SM, van Middelkoop M. Incidence and management of Osgood-Schlatter disease in general practice: retrospective cohort study. Br J Gen Pract. 2022 Mar 31;72(717):e301-e306. doi: 10.3399/BJGP.2021.0386. Print 2022 Apr.
- Launay F. Sports-related overuse injuries in children. Orthop Traumatol Surg Res. 2015 Feb;101(1 Suppl):S139-47. doi: 10.1016/j.otsr.2014.06.030. Epub 2014 Dec 30.
- Dar G, Mei-Dan E. Immediate effect of infrapatellar strap on pain and jump height in patellar tendinopathy among young athletes. Prosthet Orthot Int. 2019 Feb;43(1):21-27. doi: 10.1177/0309364618791619. Epub 2018 Aug 13.
- Lucenti L, Sapienza M, Caldaci A, Cristo C, Testa G, Pavone V. The Etiology and Risk Factors of Osgood-Schlatter Disease: A Systematic Review. Children (Basel). 2022 Jun 2;9(6):826. doi: 10.3390/children9060826.
- Corbi F, Matas S, Alvarez-Herms J, Sitko S, Baiget E, Reverter-Masia J, Lopez-Laval I. Osgood-Schlatter Disease: Appearance, Diagnosis and Treatment: A Narrative Review. Healthcare (Basel). 2022 May 30;10(6):1011. doi: 10.3390/healthcare10061011.
- Lyng KD, Rathleff MS, Dean BJF, Kluzek S, Holden S. Current management strategies in Osgood Schlatter: A cross-sectional mixed-method study. Scand J Med Sci Sports. 2020 Oct;30(10):1985-1991. doi: 10.1111/sms.13751. Epub 2020 Aug 26.
- Bezuglov EN, Tikhonova capital A, Cyrilliccapital A, Cyrillic, Chubarovskiy PV, Repetyuk capital A, CyrillicD, Khaitin VY, Lazarev AM, Usmanova EM. Conservative treatment of Osgood-Schlatter disease among young professional soccer players. Int Orthop. 2020 Sep;44(9):1737-1743. doi: 10.1007/s00264-020-04572-3. Epub 2020 Apr 28.
- Neuhaus C, Appenzeller-Herzog C, Faude O. A systematic review on conservative treatment options for OSGOOD-Schlatter disease. Phys Ther Sport. 2021 May;49:178-187. doi: 10.1016/j.ptsp.2021.03.002. Epub 2021 Mar 9.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Osgood-Schlatter disease
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osgood-Schlatter Disease
-
University Hospital, Basel, SwitzerlandCompletedOsgood-Schlatter DiseaseSwitzerland
-
Aalborg UniversityCompletedApophysitis | Osgood-Schlatter DiseaseDenmark
-
Universidad Nacional de RosarioCompleted
-
Benha UniversityCompletedOsgood-Schlatter DiseaseAlgeria
-
Cairo UniversityCompletedOsgood-Schlatter DiseaseEgypt
-
Medical University of GdanskRecruitingSever's Disease | Osgood-Schlatter DiseasePoland
-
Medical University of GdanskNot yet recruitingSever's Disease | Osgood-Schlatter Disease | Apophyseal PainPoland
-
Faculty of Medicine, SousseNot yet recruiting
-
Hospices Civils de LyonCompleted
-
Hvidovre University HospitalCompleted
Clinical Trials on kinesio tape
-
University Rovira i VirgiliCompleted
-
Haydarpasa Numune Training and Research HospitalCompletedMyofascial Pain Syndrome | Myofascial Trigger Point PainTurkey
-
Norwegian School of Sport SciencesCompletedMuscle Weakness | Shoulder PainNorway
-
Paulista UniversityCompleted
-
Izmir Katip Celebi UniversityEge UniversityNot yet recruitingBody Temperature Changes | Kinesio TapingTurkey
-
Cairo UniversityCompletedPost Mastectomy Complications
-
Paulista UniversityCompleted
-
Mayo ClinicCompleted
-
IRCCS San RaffaeleUnknownBreast Cancer | Edema | Seroma | Mastectomy | Breast ImplantationItaly
-
King Saud UniversityCompletedChronic Ankle InstabilitySaudi Arabia