NCT05320562

Brief Summary

The prevalence of knee osteoarthritis has been increasing in recent decades as the number of obese people has increased. Various interventions are used to improve the functional condition of patients, but it is still not clear which one is most effective. The primary aim of this study was to determine and compare the effects of kinesio taping and sham taping on the knee functional mobility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

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

February 20, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

March 25, 2022

Last Update Submit

April 2, 2022

Conditions

Keywords

kinesiotapingfunctional mobilityphysiotherapyknee pain

Outcome Measures

Primary Outcomes (5)

  • Change from Baseline Knee Pain at 1 week

    was evaluated using the Visual Analogue Pain Scale (VAS). Participants were asked to report "current" pain intensity. A higher score indicates greater pain intensity: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).

    Baseline and after 7 days

  • Change from Baseline Range of Motions at 1 week

    A goniometer was used to measure the flexion and extension of the knee joint. The initial position of the subject is prone lying, the axis of goniometer is placed on the lateral femoral epicondyle. The stationary part of goniometer is placed along the lateral midline of the thigh, the reference point being the greater trochanter of femur. The moving part of goniometer is placed along the midline of the lower leg, the reference point being the lateral ankle.

    Baseline and after 7 days

  • Change from Baseline Muscle Strength at 1 week

    Manual muscle strength testing. The strength of knee flexion and extension was evaluated (Cuthbert, \& Goodheart, 2007). The classic 5-point manual muscle strength assessment system is used to determine muscle strength. If for some reason participant could not perform the full range of motion, then the muscle strength test is performed at the possible amplitude.

    Baseline and after 7 days

  • Change from Baseline Walking Speed at 1 week

    A 10-meter straight line was marked in the start and finish points. The subject had to stand 2 meters in front of the start line, after the signal participant was told to walk at his/her own speed until he/she was 2 meters behind the finish line. The timer was turned on when the patient crossed the start line and stopped when he/she crossed the finish line. The test was performed 5 times and the average calculated. Time was recorded in seconds and converted to meters per second (Master et al., 2021).

    Baseline and after 7 days

  • Change from Baseline Functional Mobility at 1 week

    Initial position was participant sitting on the chair. The patient had to get up from the chair, walk three meters to the marked line, turn around 180 degrees, and return to the chair, and sit down on the chair. During the test, the person must wear normal footwear and use all means of movement normally required. The test was performed 5 times and the average of 5 tests was calculated. The height of the chair used was 46 cm and the test time was recorded in seconds (Alghadir et al., 2015).

    Baseline and after 7 days

Study Arms (3)

Control group

NO INTERVENTION

Participants underwent 3 exercise sessions for 60 minutes each. Exercise program was created to improve range of motion and muscle strength. Participants executed active exercise in lying, sitting, and standing positions, isometric exercise, exercise with resistance band. All exercises were repeated 12 times in 3 sets and depending on the capacity of the subject. Breaks between sets 10 sec.

Sham taping

SHAM COMPARATOR

Participants underwent 3 exercise sessions for 60 minutes each. Exercise program was created to improve range of motion and muscle strength. Participants executed active exercise in lying, sitting, and standing positions, isometric exercise, exercise with resistance band. All exercises were repeated 12 times in 3 sets and depending on the capacity of the subject. Breaks between sets 10 sec.

Procedure: Sham taping

Kinesio taping

EXPERIMENTAL

Participants underwent 3 exercise sessions for 60 minutes each. Exercise program was created to improve range of motion and muscle strength. Participants executed active exercise in lying, sitting, and standing positions, isometric exercise, exercise with resistance band. All exercises were repeated 12 times in 3 sets, 10 s breaks between sets.

Procedure: Kinesio taping

Interventions

Additionally, they received kinesio taping application for 7 days. Blue color kinesio tape (manufactured by "Theraband®", USA) was used. Kinesio taping was done by experienced physiotherapist with 5 years of experience. Two Y shape bands were applied for lymphatic taping and to improve anterior upper leg muscle function (lymphatic correction and muscle correction techniques were integrated together). Then two I shape bands (75-100% tension) were applied above the patella tendon and medial/lateral collateral ligaments in order to improve mechanoreceptor stimulation, proprioception and knee stability.

Kinesio taping
Sham tapingPROCEDURE

Additionally, they received sham (placebo) taping: usual white patch was applied to the painful knee for 7 days. The technique of taping used was the same as in kinesiotaping group, but without stretching.

Sham taping

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical and radiography diagnosis of osteoarthritis of the knee joint
  • patients with different degrees of severity of the knee osteoarthritis
  • consent to participate in the study.

You may not qualify if:

  • rheumatoid arthritis
  • systemic connective tissue disease
  • knee joint oedema
  • surgery intervention in recent 6 months
  • wearing of knee braces
  • skin problems
  • previous total or partial knee replacement surgery
  • inability to perform physical examination tests
  • oncology
  • use of medications, infection
  • previous experience of kinesio taping intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lithuanian Sports University

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 11, 2022

Study Start

February 20, 2021

Primary Completion

August 20, 2021

Study Completion

September 1, 2021

Last Updated

April 11, 2022

Record last verified: 2022-04

Locations