NCT05151627

Brief Summary

Knee osteoarthritis is the most common kind of arthritis that occurs due to degeneration of the joint articular cartilage, producing pain, stiffness, and impaired movement. Kinesio taping is a simple and inexpensive therapeutic procedure that can help with knee osteoarthritis symptoms. Kinesio taping is a high-stretch elastic adhesive material that allows the treated area to have free mobility. This technique was preferred by physical therapists for knee osteoarthritis rehabilitation because of its positive effects, such as decreased pain and increased mobility and muscular performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jun 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
Last Updated

December 9, 2021

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

November 20, 2021

Last Update Submit

December 8, 2021

Conditions

Keywords

KneeOsteoarthritisKinesio tapingTENSStretchingStrengthening exercise

Outcome Measures

Primary Outcomes (4)

  • NUMERICAL PAIN RATING SCALE

    The average pain intensity was measured during the past week, with zero representing no pain and ten representing the worst pain.

    6 weeks

  • GONIOMETRIC MEASUREMENT OF KNEE RANGE OF MOTION

    Both the knee flexion and extension ROM were measured while the subject was in a prone position. The measurement was done three times and the average result was obtained.

    6 weeks

  • WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX (WOMAC)

    The questionnaire was developed to measure treatment outcomes in patients with lower extremity osteoarthritis, such as pain, stiffness, and difficulty, and it employs a scale to categorize the difficulties in activities of daily living. For individuals with hip and knee osteoarthritis, the WOMAC scale is a valid and reliable outcome measurement.

    6 weeks

  • TIMED UP AND GO (TUG) TEST

    The test combines static and dynamic balance to assess a person's mobility. Getting out of a chair, walking three meters, turning around, and returning to the chair to sit. The international research OA society recommends a series of physical function measures (five performance-based) for individual with hip or knee OA, including the TUG test.24 The aforementioned outcome parameters are measured at three-time intervals: 0-week, 3-week, and 6-week.

    6 weeks

Study Arms (2)

KINESIO TAPING AND CONVENTIONAL PHYSICAL THERAPY

EXPERIMENTAL

Application of Kinesio taping following Transcutaneous Electrical Nerve Stimulation and Knee Exercises

Procedure: KINESIO TAPINGDevice: CONVENTIONAL PHYSICAL THERAPY

CONVENTIONAL PHYSICAL THERAPY

EXPERIMENTAL

Application of Transcutaneous Electrical Nerve Stimulation and Knee Exercises

Device: CONVENTIONAL PHYSICAL THERAPY

Interventions

Kinesio taping The patient is in a supine position with full knee flexion. Prior to application, the skin surface was cleaned. This technique involved the use of two Y-cut strips and two I-cut strips.

KINESIO TAPING AND CONVENTIONAL PHYSICAL THERAPY

Transcutaneous Electrical Nerve Stimulation TENS device settings, such as the frequency of 32-50 Hz, pulse width of 80 ms, and symmetrical biphasic waveform. The surface electrodes were placed on the medial and lateral superior borders of the patella, as well as the medial and lateral inferior borders of the patella. Exercise therapy program The total duration of each exercise session was about 50 minutes, including warm-up-10 minutes, resistance exercise-20 minutes, balance and stability exercise-10 minutes, lower-limb stretching exercise-5 minutes, and cool-down exercise-5 minutes. The same assigned physical therapist supervised all of the sessions.

CONVENTIONAL PHYSICAL THERAPYKINESIO TAPING AND CONVENTIONAL PHYSICAL THERAPY

Eligibility Criteria

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

You may qualify if:

  • Complaining of knee pain but no serious knee injuries
  • No Physical therapy treatment taken for the past 3 months
  • Painful range of motion (ROM)
  • Significant decrease in active and passive ROM.

You may not qualify if:

  • Knee surgery within the last three months
  • Neural, articular, or muscular conditions affecting lower limb function
  • Systemic arthritic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tabuk

Tabuk, 71491, Saudi Arabia

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSISTANT PROFESSOR

Study Record Dates

First Submitted

November 20, 2021

First Posted

December 9, 2021

Study Start

June 17, 2020

Primary Completion

December 28, 2020

Study Completion

January 22, 2021

Last Updated

December 9, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
3 MONTHS
Access Criteria
ON REQUEST

Locations