- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06306664
Effect of Two Different Modes of Polarized Polychromatic Non-coherent Light Therapy on Jumper's Knee
March 10, 2024 updated by: Mahmoud Shahien, Cairo University
The purposes of this study are:
- To examine the combined effects of Yellow CPPNLT and conventional treatment on pain intensity, pain pressure threshold, functional disability, and muscle strength in athletic jumper knee.
- To examine the combined effects of Green CPPNLT and conventional treatment on pain intensity, pain pressure threshold, functional disability, and muscle strength in athletic jumper knee.
3 3- To compare between the effects of Yellow CPPNLT and Green CPPNLT on pain intensity, pain pressure threshold, functional disability, and muscle strength in athletic jumper knee.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Jumper's knee is an overuse injury of the tendon that alters the knee due to repeated stress of activities.
Symptoms include pain in the front of the knee.
The tears are typically caused by accumulated stress on the patellar or quadriceps tendon.
As the name implies, the condition is common in athletes from jumping sports, where there is a high demand for the speed and power of leg extensors.
These sports often lead to high eccentric quadriceps loadings, such as volleyball, track (long and high jump), basketball, long-distance running, and skiing.
The prevalence of jumper knee is not well examined so far.
For non-elite adult athletes the prevalence varies between 14.4% and 2.5% for different sports.Only 2.4% of adolescent professional soccer players sustain PT.
However, knee pain, focal tenderness or even acute episodes of PT have a major impact on each player's development, time off the pitch, and career.Bioptron was used for treatment of arthritis, neck&back pain by stimulating blood circulation, reducing inflammation and relieving muscle spasm.
There are some studies that have discussed the extent of the effect of the Bioptron Light Therapy on musculoskeletal disorders such as; rotator cuff tendinitis, tennis elbow, carpal tunnel syndrome, acute patellar tendinopathy and acute ankle sprain.
There is a lack of the evidence of the clinical guidelines of patellar tendinitis.
Up to our knowledge, there is no clear recommendation about efficiency of different colors of Bioptron light therapy on jumper knee.
So; this study will be conducted to determine efficiency of yellow and green colors of polychromatic non-coherent light.
Sixty subjects will participate in this study and will be divided randomly into three equal groups.Group A (Study group): Will receive green filter of bioptron light therapy and conventional treatment for jumper knee,group B (Study group): Will receive yellow filter of bioptron light therapy and conventional treatment for jumper knee and group C (Control group): Will receive conventional treatment (ice application+ exercise program) for jumper knee.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Dokki
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Giza, Dokki, Egypt, 12612
- Physical Therapy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- History of Patellar tendinitis and anterior knee pain.
- Age will be ranged from 15 to 35 years.
- Both genders.
- The onset of pain for over 3 months.
Exclusion Criteria:
- Knee surgery within the previous 6 months.
- Chronic joint diseases.
- Corticosteroid injection in the patellar tendon within the previous 3 months.
- Use of drugs 48 hours previously (e.g., NSAIDs).
- Any other concomitant treatment for PT.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
the patients will receive green filter of bioptron light therapy and conventional treatment((ice application+ exercise program)) for jumper knee three times a week for four weeks.
|
Bioptron safely treats arthritis, neck & back pain by stimulating blood circulation, reducing inflammation and relieving muscle spasms.
For just ten minutes per day, our life-transforming technology offers the highest levels of pain relief by reaching deep into joints, muscles and ligaments.
Other Names:
|
Experimental: Group B
the patients will receive yellow filter of bioptron light therapy and conventional treatment for jumper knee three times a week for four weeks.
|
Bioptron safely treats arthritis, neck & back pain by stimulating blood circulation, reducing inflammation and relieving muscle spasms.
For just ten minutes per day, our life-transforming technology offers the highest levels of pain relief by reaching deep into joints, muscles and ligaments.
Other Names:
|
Placebo Comparator: Control group
the patients will receive conventional treatment (ice application+ exercise program) for jumper knee three times a week for four weeks.
|
Patients will receive ice application+Exercises program designed for jumper knee
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain (Visual analogue scale).
Time Frame: Visual analogue scale will be investigated at baseline and after the treatment period of 4 weeks.
|
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain.
The VAS score for grading of pain consists of a 10 centimeters (cm) line with 10 mm (0.01 cm) to each point of the scale and two end-points representing no pain and worst possible pain.
|
Visual analogue scale will be investigated at baseline and after the treatment period of 4 weeks.
|
pain intensity (Pressure algometry)
Time Frame: Pressure algometry will be investigated at baseline and after the treatment period of 4 weeks.
|
Pressure pain threshold will be measured with algometry test FPX25 using 1-cm2 rubber tip on the knee extensors.10,
11 pressures will be applied slowly until the participant first feels the pain and response by saying stop there.
|
Pressure algometry will be investigated at baseline and after the treatment period of 4 weeks.
|
Disability questionnaire (Victorian institute of sport assessment-patella).
Time Frame: The VISA-P questionnaire will be investigated at baseline and after the treatment period of 4 weeks.
|
The VISA-P, formerly known as the Victorian institute of sport assessment -patella Questionnaire, The VISA-P is questionnaire that assesses symptoms, simple tests of function, and the ability to play sports.
|
The VISA-P questionnaire will be investigated at baseline and after the treatment period of 4 weeks.
|
Muscle strength (Hand held dynamometer)
Time Frame: The Lafayette hand held dynamometer will be investigated at baseline and after the treatment period of 4 weeks.
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The subjects will be positioned in sitting on chair and we will apply resistance when performing the dynamometer on patients and they will try to make maximal effort against resistance and we will record the change of length or resistance.
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The Lafayette hand held dynamometer will be investigated at baseline and after the treatment period of 4 weeks.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle strength and endurance ( Biodex-Isokinetic Dynamometer)
Time Frame: The Isokinetic dynamometer will be investigated at baseline and after the treatment period of 4 weeks.
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The subjects will be positioned in sitting on isokinetic chair and we will ask the subjects to perform maximal knee extension and we will record the change of muscle power or endurance
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The Isokinetic dynamometer will be investigated at baseline and after the treatment period of 4 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Adel R Ahmed, PHD, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Estimated)
November 29, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
February 25, 2024
First Submitted That Met QC Criteria
March 10, 2024
First Posted (Actual)
March 12, 2024
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 10, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT.REC/012/004881
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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 Jumper's Knee
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Bispebjerg HospitalRecruitingJumper's Knee | Patellar TendinopathyDenmark
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Bispebjerg HospitalRecruitingTendinopathy | Jumper's KneeDenmark
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Bispebjerg HospitalCompletedJumper's Knee | Patellar TendinopathyDenmark
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Wingate InstituteCompletedPatellar Tendonitis | Jumper's Knee | Patellar TendinopathyIsrael
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University of DelawareCompletedJumper's Knee | Patellar Tendinopathy | Patellar Tendinitis | Patellar Tendon Pain | Patellar TendinosisUnited States
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