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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06227078
Other study ID # RHPT/021/093
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date August 30, 2023

Study information

Verified date January 2024
Source Prince Sattam Bin Abdulaziz University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Degenerative meniscal tears are a common cause of osteoarthritis commonly diagnosed in football players and are considered a major risk factor for the development of knee osteoarthritis. This study aimed to investigate the Clinical and functional effects of kinesiotaping and physiotherapy in grade 2 osteoarthritis following degenerative meniscal tears in football players.


Description:

Degenerative meniscal tears represent a prevalent issue among football players and are frequently associated with an increased risk of developing knee osteoarthritis. This study seeks to explore the clinical and functional impacts of employing kinesiotaping and physiotherapy as interventions in grade 2 osteoarthritis resulting from degenerative meniscal tears in football players. Kinesiotaping is a therapeutic technique involving the application of specialized elastic tapes to targeted areas, aiming to support injured muscles and joints, enhance circulation, and alleviate pain. Physiotherapy, on the other hand, employs a range of exercises and modalities to promote healing and improve joint function. Both modalities are commonly used in sports medicine to manage musculoskeletal injuries. The investigation focuses on football players diagnosed with grade 2 osteoarthritis secondary to degenerative meniscal tears. Grade 2 osteoarthritis signifies moderate cartilage loss and potential joint instability. The participants will be divided into two groups: one receiving kinesiotaping in combination with physiotherapy and the other undergoing conventional physiotherapy alone. Clinical assessments will include pain levels, joint swelling, and range of motion. Functional outcomes such as strength, agility, and proprioception will be measured through standardized tests. The study's duration and follow-up periods will allow for a comprehensive evaluation of both short-term and long-term effects. The hypothesis underlying this research posits that the combined approach of kinesiotaping and physiotherapy will yield superior outcomes compared to traditional physiotherapy alone. Potential benefits may include reduced pain, improved joint stability, enhanced functional capacity, and a decreased risk of further degeneration. By shedding light on the efficacy of these interventions, this study aspires to contribute valuable insights to the field of sports medicine, aiding in the development of evidence-based strategies for managing degenerative meniscal tears and mitigating the risk of osteoarthritis in football players. The findings could inform clinical practice and potentially influence rehabilitation protocols for athletes facing similar challenges.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date August 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: Diagnosis of Knee Osteoarthritis: Individuals with a confirmed diagnosis of knee osteoarthritis based on clinical and/or radiological assessments. Mild to Moderate Knee OA: Kinesiotaping may be more appropriate for individuals with mild to moderate knee OA rather than severe cases. Presence of Pain and Discomfort: Individuals experiencing pain, discomfort, or limitations in function related to knee osteoarthritis. Functional Limitations: Those with functional limitations in activities of daily living or reduced mobility due to knee OA. No Contraindications: Individuals without contraindications to kinesiotaping, such as skin allergies, infections, or open wounds in the application area. Willingness to Participate: Individuals who are willing to participate in and adhere to the kinesiotaping intervention. Not Responsive to Other Conservative Treatments: Those who have tried and not responded adequately to other conservative treatments for knee OA, such as exercise, physical therapy, or oral medications. Absence of Serious Comorbidities: Individuals without serious comorbidities or medical conditions that may contraindicate the use of kinesiotaping. Individual Preferences: Consideration of individual preferences and acceptance of kinesiotaping as part of the treatment plan. Exclusion Criteria: - 1. Skin Conditions: - Active skin infections, allergies, or open wounds in the area where kinesiotape is to be applied. - Skin conditions that may be aggravated or worsened by the adhesive in the tape. 2. Vascular Disorders: - Conditions that affect blood circulation, such as peripheral vascular disease, deep vein thrombosis, or other vascular disorders, which may be worsened by the application of kinesiotape. 3. Peripheral Neuropathy: - Individuals with peripheral neuropathy or other nerve disorders, as kinesiotaping may affect sensation, and there is a risk of injury or discomfort. 4. Cancer or Tumors: - Active cancer or tumors in the region where kinesiotape is to be applied, as kinesiotaping could interfere with cancer treatment or exacerbate symptoms. 5. Joint Instability: - Individuals with severe joint instability, as kinesiotape may not provide sufficient support for highly unstable joints. 6. Allergies to Tape Components: - Known allergies to the materials or adhesive used in kinesiotape. 7. Circulatory Disorders: - Severe circulatory disorders, which may be exacerbated by the pressure or tension applied by kinesiotape.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Kinesiotaping
Kinesiotaping is commonly used in sports medicine and rehabilitation settings. It is applied by trained professionals, such as physiotherapists or athletic trainers, who are skilled in assessing individual needs and determining the appropriate taping technique for specific conditions. The tape is typically worn for several days, allowing for continuous therapeutic effects. It's important to note that while kinesiotaping has gained popularity, its effectiveness is still a subject of ongoing research, and its application should be part of a comprehensive treatment plan. Individual responses to kinesiotape may vary, and its use is often combined with other therapeutic interventions for optimal results.

Locations

Country Name City State
Saudi Arabia Saud Alrawilli Al Kharj Riyad

Sponsors (1)

Lead Sponsor Collaborator
Gopal Nambi

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity - Visual analog scale The VAS is usually presented as a straight line, often 10 centimeters (or another standard length), with two endpoints representing extreme points on a continuum. For example, one end may be labeled "No Pain" or "No Symptoms," and the other end labeled "Worst Pain Imaginable" or "Maximum Symptoms." Baseline
Primary Pain intensity - Visual analog scale The VAS is usually presented as a straight line, often 10 centimeters (or another standard length), with two endpoints representing extreme points on a continuum. For example, one end may be labeled "No Pain" or "No Symptoms," and the other end labeled "Worst Pain Imaginable" or "Maximum Symptoms." 8 weeks
Primary Pain intensity - Visual analog scale The VAS is usually presented as a straight line, often 10 centimeters (or another standard length), with two endpoints representing extreme points on a continuum. For example, one end may be labeled "No Pain" or "No Symptoms," and the other end labeled "Worst Pain Imaginable" or "Maximum Symptoms." 6 months
Secondary Functional disability - WOMAC The WOMAC scale consists of three subscales, each assessing a different dimension of health related to osteoarthritis. Baseline
Secondary Functional disability - WOMAC The WOMAC scale consists of three subscales, each assessing a different dimension of health related to osteoarthritis. 8 weeks
Secondary Functional disability - WOMAC The WOMAC scale consists of three subscales, each assessing a different dimension of health related to osteoarthritis. 6 months
Secondary Sports performance - Timed up and go test Ask the individual to sit in the chair with their back against the backrest and their arms on the chair arms (if available). On the "go" signal, instruct them to stand up, walk around the first cone, return to the chair, and sit back down. Use a stopwatch to measure the time it takes for the individual to complete the task. Faster times generally indicate better agility and functional mobility. Baseline
Secondary Sports performance - Timed up and go test Ask the individual to sit in the chair with their back against the backrest and their arms on the chair arms (if available). On the "go" signal, instruct them to stand up, walk around the first cone, return to the chair, and sit back down. Use a stopwatch to measure the time it takes for the individual to complete the task. Faster times generally indicate better agility and functional mobility. 8 weeks
Secondary Sports performance - Timed up and go test Ask the individual to sit in the chair with their back against the backrest and their arms on the chair arms (if available). On the "go" signal, instruct them to stand up, walk around the first cone, return to the chair, and sit back down. Use a stopwatch to measure the time it takes for the individual to complete the task. Faster times generally indicate better agility and functional mobility. 6 months
Secondary Sports performance - 40 Metre zig zag test Set up a zigzagging path using cones or markers. The path should be 40 meters in total length. The zigzag pattern should include sharp turns, requiring participants to change direction quickly. Explain the test to the participant, emphasizing the need to navigate through the zigzag path as quickly as possible.
Emphasize the importance of agility, speed, and quick changes in direction. Use a stopwatch or timer to measure the time it takes for the participant to complete the 40-meter zigzag course. On the "go" signal, the participant should start from the beginning and navigate through the zigzag path as quickly as possible.
Time should be recorded when the participant crosses the finishing line.
Baseline
Secondary Sports performance - 40 Metre zig zag test Set up a zigzagging path using cones or markers. The path should be 40 meters in total length. The zigzag pattern should include sharp turns, requiring participants to change direction quickly. Explain the test to the participant, emphasizing the need to navigate through the zigzag path as quickly as possible.
Emphasize the importance of agility, speed, and quick changes in direction. Use a stopwatch or timer to measure the time it takes for the participant to complete the 40-meter zigzag course. On the "go" signal, the participant should start from the beginning and navigate through the zigzag path as quickly as possible.
Time should be recorded when the participant crosses the finishing line.
8 weeks
Secondary Sports performance - 40 Metre zig zag test Set up a zigzagging path using cones or markers. The path should be 40 meters in total length. The zigzag pattern should include sharp turns, requiring participants to change direction quickly. Explain the test to the participant, emphasizing the need to navigate through the zigzag path as quickly as possible.
Emphasize the importance of agility, speed, and quick changes in direction. Use a stopwatch or timer to measure the time it takes for the participant to complete the 40-meter zigzag course. On the "go" signal, the participant should start from the beginning and navigate through the zigzag path as quickly as possible.
Time should be recorded when the participant crosses the finishing line.
6 months
Secondary Quality of life - SF-12 The Short Form Health Survey (SF-12) is a widely used and validated questionnaire designed to assess health-related quality of life (HRQoL) across various populations. It is a shorter version of the SF-36 and provides a quick and reliable measure of general health status. The SF-12 includes 12 questions covering eight health domains and yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Baseline
Secondary Quality of life - SF-12 The Short Form Health Survey (SF-12) is a widely used and validated questionnaire designed to assess health-related quality of life (HRQoL) across various populations. It is a shorter version of the SF-36 and provides a quick and reliable measure of general health status. The SF-12 includes 12 questions covering eight health domains and yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). 8 weeks
Secondary Quality of life - SF-12 The Short Form Health Survey (SF-12) is a widely used and validated questionnaire designed to assess health-related quality of life (HRQoL) across various populations. It is a shorter version of the SF-36 and provides a quick and reliable measure of general health status. The SF-12 includes 12 questions covering eight health domains and yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). 6 months
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