NCT06327243

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2024

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

March 12, 2024

Last Update Submit

May 25, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • Knee range of motion

    the knee range of motion measured by goniometer

    At baseline (pre-intervention), and then repeated immediately after the intervention

  • 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

  • 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

  • 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

Study Arms (2)

Kineso taping group

EXPERIMENTAL
Other: Elastic tape ( kinesio tape)

Sham group

SHAM COMPARATOR
Other: Sham Taping

Interventions

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.

Kineso taping group

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.

Sham group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients clinically and radiologically diagnosed with unilateral or bilateral knee OA.
  • Independent gait
  • Any grade on the Kellgren-Lawrence scale

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taibah University

Madinah, 42353, Saudi Arabia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Marwan MA Aljohani, Phd

    Taibah University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not know if they are receiving the actual Kinesio Taping (KT) treatment or a sham taping. The KT will be applied following the correct standards for the rectus femoris muscle, including appropriate stretching. Conversely, the placebo taping will be applied horizontally across the muscle fibers without any stretching. The therapists applying the tape will know which treatment each participant is allocated to ensure that the application of either the real KT or the placebo taping aligns with the study's protocol.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 25, 2024

Study Start

March 1, 2024

Primary Completion

April 30, 2024

Study Completion

May 9, 2024

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations