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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06327243
Other study ID # TUMRHS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date May 1, 2024

Study information

Verified date April 2024
Source Taibah University
Contact President of the University
Phone 00966148618888
Email tawasul@taibahu.edu.sa
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the effectiveness of Kinesio Taping in individuals with knee osteoarthritis (KOA). KOA is a common condition that can lead to pain, stiffness, and decreased mobility. The main questions it aims to answer are: - Does Kinesio Taping reduce pain in individuals with KOA? - Can Kinesio Taping improve the range of motion and functional performance in those suffering from KOA? Participants will be asked to: Attend assessment sessions at the outpatient Physical Therapy clinic at Taibah University. Undergo Kinesio Taping three times over 12 days. Complete specific physical tests and questionnaires before and after the intervention period to measure their pain and mobility. Researchers will compare the group that receives Kinesio Taping with the group that receives sham (placebo) taping to see if there are significant differences in pain reduction and improvements in movement and daily function.


Description:

Study Overview This clinical trial explores Kinesio Taping's (KT) effect on knee osteoarthritis (KOA) in adults. It delves into whether KT can alleviate pain and improve joint movement and daily functioning. The research, hosted at Taibah University's Physical Therapy clinic, focuses on practical benefits for patients with KOA, a condition that leads to significant discomfort and mobility issues, especially prevalent in Saudi Arabia. Study Design In a randomized and single-blinded approach, participants are divided into two groups. One group receives actual Kinesio taping, while the other undergoes a sham procedure, with neither group aware of their specific treatment type to ensure unbiased results. Intervention Procedures Participants undergo three Kinesio taping sessions spread over 12 days. The taping technique is performed according to prescribed methods that target the quadriceps femoris muscle, believed to influence pain perception and joint function positively. The study employs a before-and-after intervention assessment model. Initial data collection includes patients' demographic details and baseline characteristics related to their health status and disease severity. Following the intervention, the same measures are reassessed to evaluate any changes attributed to the KT.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 1, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria: - Patients clinically and radiologically diagnosed with unilateral or bilateral knee OA. - Independent gait - Any grade on the Kellgren-Lawrence scale Exclusion Criteria: - Previous fractures of the femur and/or tibia. - Comorbidities such as neurological diseases, malnutrition, and other inflammatory and/or infectious diseases. - Radicular pain in the lower limbs or diabetic neuritis. - Prior physiotherapy in the past month.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Elastic tape ( kinesio tape)
This group will receive the tape on their quadriceps femoris muscle. First, the tape will be cut in a Y-shaped Kinesio type and then applied over the quadriceps femoris muscle. The tape will be applied at a point of 5 cm inferior to the anterior superior iliac spine to the patella (origin to insertion), with the patient in a supine position with 25% tension on the tape. Then, each patient will flex his or her knee, and the Y-shaped tape (the end of the tape) will be circled around the patella, ending at its inferior side with no tension.
Sham Taping
Sham taping will be applied horizontally across the muscle fibers without any stretching. the tape here will be applied transverse to the quadriceps femoris muscle. The patients will be in a supine position with their hips flexed at 30 degrees and their knees flexed at 60 degrees.

Locations

Country Name City State
Saudi Arabia Taibah University Medina

Sponsors (1)

Lead Sponsor Collaborator
Taibah University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain (Visual analog scale) a tool that measures pain intensity. It consists of a straight line, typically 10 cm long, with "no pain" on one end and "severe pain" on the other. Participants mark a point on the line that represents their current level of pain, providing a quantitative measure of pain intensity. At baseline (pre-intervention), and then repeated immediately after the intervention
Primary Knee range of motion the knee range of motion measured by goniometer At baseline (pre-intervention), and then repeated immediately after the intervention
Primary Timed up and go test measures mobility by timing how long it takes a person to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Longer times suggest decreased mobility and a higher fall risk. At baseline (pre-intervention), and then repeated immediately after the intervention
Primary The 50-foot Walk measures walking speed over a short distance. Participants walk 50 feet as quickly and safely as possible, and the time taken is recorded. This test assesses functional mobility and endurance. At baseline (pre-intervention), and then repeated immediately after the intervention
Primary Knee Osteoarthritis Outcome Score (KOOS) is a patient-reported questionnaire developed to assess the patient's opinion about their knee and associated problems. It consists of five subscales: Pain, Other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. It is widely used in the assessment of the short-term and long-term consequences of knee osteoarthritis. At baseline (pre-intervention), and then repeated immediately after the intervention
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